Trial Outcomes & Findings for Caring Others Increasing EngageMent in PACT (NCT NCT02328326)

NCT ID: NCT02328326

Last Updated: 2021-10-06

Results Overview

Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 478 participants
• Primary outcome timeframe: Baseline to 12 months
• Results posted on: 2021-10-06

Participant Flow

Participants were recruited from 11/16/16 to 5/22/18. Eligible patient participants were identified from one of two participating VHA sites. Once identified, they received an introductory letter about the study and indicated interest by phone or mail.

None. All patient-supporter dyads who enrolled in the study were randomized to one of two study arms.

Participant milestones

Measure	CO-IMPACT patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	PACT patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Overall Study STARTED	246	232
Overall Study 6-month Follow Up	221	221
Overall Study COMPLETED	224	224
Overall Study NOT COMPLETED	22	8

Reasons for withdrawal

Measure	CO-IMPACT patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	PACT patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Overall Study Withdrawal by Subject	10	3
Overall Study Death	2	1
Overall Study Lost to Follow-up	10	4

Baseline Characteristics

Care Partner participant age was not collected in this study. Therefore median ages reflect only patient participants' median age.

Baseline characteristics by cohort

Measure	CO-IMPACT n=246 Participants patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	PACT n=232 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits	Total n=478 Participants Total of all reporting groups
Age, Continuous Patient Participants	62 years n=123 Participants • Care Partner participant age was not collected in this study. Therefore median ages reflect only patient participants' median age.	64 years n=116 Participants • Care Partner participant age was not collected in this study. Therefore median ages reflect only patient participants' median age.	64 years n=239 Participants • Care Partner participant age was not collected in this study. Therefore median ages reflect only patient participants' median age.
Sex: Female, Male Patient Participants · Female	6 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	2 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	8 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Sex: Female, Male Patient Participants · Male	117 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	114 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	231 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Sex: Female, Male Care Partners · Female	14 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	10 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	24 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Sex: Female, Male Care Partners · Male	109 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	106 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	215 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Patient Participants · Hispanic or Latino	10 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	4 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	14 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Patient Participants · Not Hispanic or Latino	112 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	112 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	224 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Patient Participants · Unknown or Not Reported	1 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Care Partners · Hispanic or Latino	6 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	5 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	11 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Care Partners · Not Hispanic or Latino	117 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	111 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	228 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Ethnicity (NIH/OMB) Care Partners · Unknown or Not Reported	0 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · American Indian or Alaska Native	6 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	6 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · Asian	0 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · Native Hawaiian or Other Pacific Islander	0 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · Black or African American	12 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	18 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	30 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · White	90 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	92 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	182 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · More than one race	6 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	6 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Patient Participants · Unknown or Not Reported	9 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	5 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	14 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · American Indian or Alaska Native	1 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · Asian	0 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	1 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · Native Hawaiian or Other Pacific Islander	0 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	0 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · Black or African American	10 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	16 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	26 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · White	103 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	92 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	195 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · More than one race	5 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	2 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	7 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Race (NIH/OMB) Care Partners · Unknown or Not Reported	4 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	5 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	9 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Region of Enrollment United States	246 Participants n=246 Participants	232 Participants n=232 Participants	478 Participants n=478 Participants
Insulin Use among Patient Participants	78 Participants n=123 Participants • Insulin Use was only collected for patient participants, but not their care partners.	64 Participants n=116 Participants • Insulin Use was only collected for patient participants, but not their care partners.	142 Participants n=239 Participants • Insulin Use was only collected for patient participants, but not their care partners.
PAM-13 Cutoff PAM-13 Prorated Score <40	55 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	65 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	120 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
PAM-13 Cutoff PAM-13 Prorated Score >40	68 Participants n=123 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	51 Participants n=116 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.	119 Participants n=239 Participants • Participants were recruited in patient-care partner dyads. As such, each row population has half as many participants analyzed as the total sample. For CO-IMPACT dyads, 246 total participants becomes 123 patient participants and 123 care partners. For PACT dyads, 232 becomes 116 and 116.
Care Partner Lives with Patient Participant	86 Participants n=123 Participants • This measure is specific to the care partners only.	82 Participants n=116 Participants • This measure is specific to the care partners only.	168 Participants n=239 Participants • This measure is specific to the care partners only.
Patient Baseline Patient Activation Measure (PAM-13)	62.8 units on a scale STANDARD_DEVIATION 11.2 • n=123 Participants • This measure includes data from Patient Participants only	59.8 units on a scale STANDARD_DEVIATION 12.6 • n=116 Participants • This measure includes data from Patient Participants only	61.3 units on a scale STANDARD_DEVIATION 12.0 • n=239 Participants • This measure includes data from Patient Participants only
Baseline UKPDS 5-Year Cardiac Risk Score	14.7 units on a scale STANDARD_DEVIATION 10.0 • n=123 Participants • UKPDS Score only assessed among patient participants.	13.6 units on a scale STANDARD_DEVIATION 9.9 • n=116 Participants • UKPDS Score only assessed among patient participants.	14.2 units on a scale STANDARD_DEVIATION 9.9 • n=239 Participants • UKPDS Score only assessed among patient participants.
Enrolled at Hospital-based clinic (vs. community clinic site)	78 Participants n=123 Participants • This measure is only among patient participants.	87 Participants n=116 Participants • This measure is only among patient participants.	165 Participants n=239 Participants • This measure is only among patient participants.

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.

Patient Activation Measure-13. Range of potential values (0,100), higher scores mean a better outcome, Outcome is the participant's difference in the measure between baseline and 12 months, among patient participants

Outcome measures

Measure	CO-IMPACT n=123 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=116 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Patient Activation, as Measured by Patient Activation Measure - 13	2.94 units on a scale Standard Deviation 9.86	1.78 units on a scale Standard Deviation 10.84

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population.

UKPDS Risk Engine, among patient participants only, range is 0 to 100% risk of cardiac event over the next 5 years. Lower score equals a better outcome. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=123 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=116 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Cardiac Event 5-year Risk Score, as Measured by UKPDS Risk Engine	0.14 units on a scale Standard Deviation 6.77	-0.73 units on a scale Standard Deviation 6.51

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for healthy eating subscale (0 - 7 days per week), higher scores mean better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=116 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Healthy Eating	1.12 score on a scale Standard Deviation 2.30	0.50 score on a scale Standard Deviation 2.54

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Hemoglobin A1c, among patient participants. Common range is 4% to 14%, lower values indicate better outcomes. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=114 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Glycemic Control	-0.05 percent of glycosylated hemoglobin Standard Deviation 1.38	-0.28 percent of glycosylated hemoglobin Standard Deviation 1.43

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

mmHg, Average of two readings done at each time point. Common physiologic range is 80mmHg - 220mmHg. Lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=110 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=110 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Systolic Blood Pressure	-6.41 mmHg Standard Deviation 1.75	-2.46 mmHg Standard Deviation 1.77

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Problem Areas in Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=114 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=111 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Distress	-0.25 score on a scale Standard Deviation 4.06	-0.62 score on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Perceived Efficacy in Patient-Physician Interactions (PEPPI-5) - range of potential values (5, 25), higher scores indicate better outcomes (higher perceived self-efficacy in patient-physician interactions), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Activation in Health Encounters	0.23 score on a scale Standard Deviation 3.41	0.33 score on a scale Standard Deviation 4.01

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Total cholesterol mg/DL to HDL mg/DL Ratio, common range is 1-10, lower values indicate better outcomes, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=114 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Non-Fasting Lipid Levels	-0.11 mg/dL Standard Deviation 0.99	-0.21 mg/dL Standard Deviation 1.01

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Measured as percent of patient participants answering they were 'very satisfied' or 'satisfied' with healthcare system support for their Care Partner (family supporter)'s participation in their healthcare. Response options were 'very unsatisfied', 'unsatisfied', 'neither', 'satisfied', or 'very satisfied'. Increase in proportion of 'very satisfied' or 'satisfied' indicates better outcomes (higher satisfaction), among patient participants.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=111 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Patient Satisfaction With Healthcare System Support for Family Supporter Number moving from not satisfied/neither to satisfied	35 Participants	20 Participants
Change in Patient Satisfaction With Healthcare System Support for Family Supporter Those not changing or getting worse	80 Participants	91 Participants

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Important Other Climate Questionnaire (IOCQ) - patient rating of supporter communication. Range of potential values (1,7), higher scores indicate better outcomes (higher patient perception of supporter use of autonomy supportive communication), among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=110 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Supporter Use of Autonomy-Supportive Communication	0.27 score on a scale Standard Deviation 0.93	0.05 score on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Global Adult Tobacco Survey, values include 'current smoker', 'former smoker', or 'never smoker'. Change from current to former smoker over 12 months indicates a better outcome. Measured among patient participants.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Smoking Status Changed from active smoker at baseline to non-smoker at 12 months	2 Participants	3 Participants
Change in Smoking Status Changed from non-smoker at baseline to smoker at 12 months	1 Participants	5 Participants
Change in Smoking Status No change	112 Participants	105 Participants

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values for physical activity subscale (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Physical Activity	0.09 score on a scale Standard Deviation 2.46	0.46 score on a scale Standard Deviation 2.13

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=101 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=94 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Blood Sugar Home Testing	0.17 score on a scale Standard Deviation 1.75	0.19 score on a scale Standard Deviation 1.80

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: This outcome was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=75 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=62 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Blood Pressure Home Testing	0.51 score on a scale Standard Deviation 2.52	0.48 score on a scale Standard Deviation 1.88

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=99 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=96 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Take Oral Meds as Prescribed	0.14 score on a scale Standard Deviation 1.17	0.23 score on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=73 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=61 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Take Insulin as Prescribed	0.14 score on a scale Standard Deviation 1.34	0.48 score on a scale Standard Deviation 2.08

SECONDARY outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Summary of Diabetes Self-Care Activities (SDSCA) - range of potential values (0-7 days per week), higher scores mean better outcome, among patient participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Management Behavior - Check Feet	0.72 score on a scale Standard Deviation 2.06	0.72 score on a scale Standard Deviation 2.26

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Adapted Stanford Chronic Disease self-efficacy scale, among patient participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=115 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=113 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Diabetes Self-Efficacy	0.26 score on a scale Standard Deviation 1.38	0.23 score on a scale Standard Deviation 1.48

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Adapted Stanford Chronic Disease self-efficacy scale, among family supporter participants. Range of potential values (1,10), higher score indicates higher self-efficacy. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=108 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=110 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Supporter Self-Efficacy for Helping With Diabetes Care	0.19 score on a scale Standard Deviation 1.77	0.29 score on a scale Standard Deviation 1.83

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Caregiver Strain Index - range of potential values (0,13), higher scores (7 or more) mean worse outcomes, among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=108 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=108 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Caregiver Burden	0.18 score on a scale Standard Deviation 3.77	-0.54 score on a scale Standard Deviation 3.30

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Population: The outcomes was assessed only among patient participants and not among family supporters, so sample size for these analyses are approximately half of the total study population. Only participants with complete baseline and 12 month data for the outcome were included in that outcome's analysis.

Adapted Problem Areas In Diabetes Scale (PAID) - range of potential values (0,20), higher scores indicate worse outcomes (greater diabetes-related emotional distress), among family supporter participants. Outcome is the participant's difference in the measure between baseline and 12 months.

Outcome measures

Measure	CO-IMPACT n=107 Participants patient and supporter (dyad) receive one 45-minute coaching session on understanding care partner's role; understanding patient's diabetes-related health information; patient engagement (action planning, communicating with providers); effective supporter techniques; and how to navigate VA resources (explain what PACT team is, how to reach them, VA diabetes-related programs). Throughout the year of the CO-IMPACT intervention, patient-supporter dyads receive preparation by phone before patients' primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter.	PACT n=108 Participants patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which follow VA/DoD diabetes management guidelines. At the primary care team's discretion, patients in PACT may also receive: nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits. Participants will also be given access to the CO-IMPACT educational information on general diabetes management in web or hardcopy format. PACT: participants will receive PACT care for high-risk diabetes, which may include (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, and clinical pharmacist visits.
Change in Supporter Distress About Patient Participant's Diabetes	-0.50 score on a scale Standard Deviation 3.57	-1.08 score on a scale Standard Deviation 3.71

Adverse Events

CO-IMPACT

Serious events: 29 serious events

Other events: 0 other events

Deaths: 2 deaths

PACT

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	CO-IMPACT n=246 participants at risk patient and supporter (dyad) receive one coaching session on action planning, communicating with providers, navigation skills and support skills; preparation by phone before patients? primary care visits; after-visit summaries by mail; and biweekly automated phone calls to prompt action on new patient health concerns CO-IMPACT: Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter	PACT n=232 participants at risk patient and their health supporter (dyad) will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits PACT: participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
Cardiac disorders Cardiac Events	2.4% 6/246 • Number of events 6 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Vascular disorders Vascular Issues	1.2% 3/246 • Number of events 3 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.43% 1/232 • Number of events 1 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Infections and infestations Infection	1.6% 4/246 • Number of events 4 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Surgical and medical procedures Surgeries	1.6% 4/246 • Number of events 4 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Injury, poisoning and procedural complications Injury	1.6% 4/246 • Number of events 4 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Nervous system disorders Stroke	1.6% 4/246 • Number of events 4 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
General disorders General Diagnoses, Hospitalizations	0.81% 2/246 • Number of events 2 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.43% 1/232 • Number of events 1 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
Social circumstances Social Circumstances	0.41% 1/246 • Number of events 1 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.
General disorders Multiple Issues	0.41% 1/246 • Number of events 1 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.	0.00% 0/232 • Adverse event data were collected during the year participants were enrolled in the study. All participants participated between the dates of 01/03/17 to 06/03/19. Definitions of adverse event and serious adverse event used by study team were consistent with the clinicaltrials.gov definitions. Adverse events were collected when self-reported by participants or family members when study staff reached out to schedule or conduct intervention components or assessment visits.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ann-Marie Rosland

VA Pittsburgh Healthcare System, Center for Health Equity Research and Promotion

Phone: 4123602259

Email: Ann-Marie.rosland@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place