Trial Outcomes & Findings for Veteran Support and Resources for Diabetes (NCT NCT04041375)
NCT ID: NCT04041375
Last Updated: 2024-11-07
Results Overview
The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden ("Feeling angry, scared and/or depressed when I think about living with diabetes"), Physician-related Distress ("Feeling that my doctor doesn't take my concerns seriously enough"), Regimen-related Distress ("Not feeling confident in my day-to-day ability to manage diabetes"), and Interpersonal Distress ("Feeling that friends or family don't give me the emotional support that I would like"). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
219 participants
Primary outcome timeframe
Baseline, Month 3, Month 6
Results posted on
2024-11-07
Participant Flow
Of the 1,614 Veterans considered for study entry (1,499 referred from VA sources, 110 referred from community sources, 5 referred from both VA and community sources), 1,109 were contacted, 503 were screened, and 219 were eligible/provided informed consent for study participation.
One participant who provided informed consent withdrew prior to completing baseline/randomization.
Participant milestones
| Measure |
iNSPiRED
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Intervention Phase
STARTED
|
110
|
108
|
|
Intervention Phase
COMPLETED
|
108
|
106
|
|
Intervention Phase
NOT COMPLETED
|
2
|
2
|
|
Follow-up Phase
STARTED
|
108
|
106
|
|
Follow-up Phase
COMPLETED
|
101
|
105
|
|
Follow-up Phase
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
iNSPiRED
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Intervention Phase
Withdrawal by Subject
|
2
|
2
|
|
Follow-up Phase
Death
|
2
|
0
|
|
Follow-up Phase
Lost to Follow-up
|
2
|
1
|
|
Follow-up Phase
Too ill
|
3
|
0
|
Baseline Characteristics
Veteran Support and Resources for Diabetes
Baseline characteristics by cohort
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
53 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Age, Continuous
|
63.35 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
62.37 years
STANDARD_DEVIATION 11.13 • n=7 Participants
|
62.86 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
57 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
Education
High School/GED/No Diploma
|
35 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Education
Some College or Technical School
|
46 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Education
Bachelors Degree
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Education
Graduate or Professional Degree
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Annual Income
<$20k
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Annual Income
$20k-$39,999k
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Annual Income
$40k-$59,999k
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Annual Income
$60k +
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
17-item Diabetes Distress Scale (DDS17)--Total Score
|
3.04 units on a scale
STANDARD_DEVIATION 1.11 • n=5 Participants
|
3.06 units on a scale
STANDARD_DEVIATION 1.07 • n=7 Participants
|
3.05 units on a scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
|
Uses any diabetes medication
Yes
|
107 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
|
Uses any diabetes medication
No
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Uses insulin
Yes
|
56 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Uses insulin
No
|
54 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ever hospitalized for diabetes
Yes
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Ever hospitalized for diabetes
No
|
83 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample
The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden ("Feeling angry, scared and/or depressed when I think about living with diabetes"), Physician-related Distress ("Feeling that my doctor doesn't take my concerns seriously enough"), Regimen-related Distress ("Not feeling confident in my day-to-day ability to manage diabetes"), and Interpersonal Distress ("Feeling that friends or family don't give me the emotional support that I would like"). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Diabetes Distress Screening Scale (DDS17)
Baseline--Total Score
|
3.0 score on a scale
Standard Deviation 1.1
|
3.1 score on a scale
Standard Deviation 1.1
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Baseline--Emotional Burden Subscale
|
3.3 score on a scale
Standard Deviation 1.3
|
3.3 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Baseline--Physician-Related Distress Subscale
|
2.7 score on a scale
Standard Deviation 1.3
|
2.6 score on a scale
Standard Deviation 1.3
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Baseline--Regimen-Related Distress Subscale
|
3.5 score on a scale
Standard Deviation 1.3
|
3.5 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Baseline--Interpersonal Distress Subscale
|
2.4 score on a scale
Standard Deviation 1.4
|
2.6 score on a scale
Standard Deviation 1.5
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 3--Total Score
|
2.6 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation 1.4
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 3--Emotional Burden Subscale
|
2.7 score on a scale
Standard Deviation 1.2
|
2.8 score on a scale
Standard Deviation 1.1
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 3--Physician-Related Distress Subscale
|
2.4 score on a scale
Standard Deviation 1.2
|
2.4 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 3--Regimen-Related Distress Subscale
|
2.8 score on a scale
Standard Deviation 1.2
|
3.0 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 3--Interpersonal Distress Subscale
|
2.3 score on a scale
Standard Deviation 1.4
|
2.2 score on a scale
Standard Deviation 1.3
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 6--Total Score
|
2.6 score on a scale
Standard Deviation 1.0
|
2.6 score on a scale
Standard Deviation 1.0
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 6--Emotional Burden
|
2.7 score on a scale
Standard Deviation 1.2
|
2.7 score on a scale
Standard Deviation 1.1
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 6--Physician-Related
|
2.4 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 6--Regimen-Related
|
2.8 score on a scale
Standard Deviation 1.1
|
2.9 score on a scale
Standard Deviation 1.2
|
|
Change in Diabetes Distress Screening Scale (DDS17)
Month 6--Interpersonal
|
2.4 score on a scale
Standard Deviation 1.4
|
2.2 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample.
The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry).
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--General Diet
|
3.3 score on a scale
Standard Deviation 2.1
|
3.3 score on a scale
Standard Deviation 2.2
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--Specific Diet (Fruits and Vegetables)
|
2.8 score on a scale
Standard Deviation 2.2
|
2.8 score on a scale
Standard Deviation 2.4
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--Specific Diet (Fat)
|
3.7 score on a scale
Standard Deviation 2.0
|
3.1 score on a scale
Standard Deviation 2.0
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--Physical Activity
|
2.7 score on a scale
Standard Deviation 2.4
|
2.4 score on a scale
Standard Deviation 2.3
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--Blood Glucose Testing
|
3.0 score on a scale
Standard Deviation 2.7
|
3.3 score on a scale
Standard Deviation 2.7
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Baseline--Foot Care
|
4.0 score on a scale
Standard Deviation 2.2
|
3.7 score on a scale
Standard Deviation 2.5
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--General Diet
|
4.2 score on a scale
Standard Deviation 1.6
|
3.7 score on a scale
Standard Deviation 2.1
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--Specific Diet (Fruits and Vegetables)
|
3.2 score on a scale
Standard Deviation 2.2
|
3.1 score on a scale
Standard Deviation 2.6
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--Specific Diet (Fat)
|
3.9 score on a scale
Standard Deviation 1.9
|
3.8 score on a scale
Standard Deviation 2.0
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--Physical Activity
|
3.3 score on a scale
Standard Deviation 2.2
|
2.7 score on a scale
Standard Deviation 2.2
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--Blood Glucose Testing
|
3.5 score on a scale
Standard Deviation 2.6
|
3.9 score on a scale
Standard Deviation 2.6
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 3--Foot Care
|
4.3 score on a scale
Standard Deviation 2.2
|
4.1 score on a scale
Standard Deviation 2.4
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--General Diet
|
4.0 score on a scale
Standard Deviation 1.6
|
3.8 score on a scale
Standard Deviation 1.8
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--Specific Diet (Fruits and Vegetables)
|
3.2 score on a scale
Standard Deviation 2.2
|
3.0 score on a scale
Standard Deviation 2.2
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--Specific Diet (Fat)
|
4.0 score on a scale
Standard Deviation 1.7
|
3.6 score on a scale
Standard Deviation 2.0
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--Physical Activity
|
3.1 score on a scale
Standard Deviation 2.3
|
2.6 score on a scale
Standard Deviation 2.0
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--Blood Glucose Testing
|
3.5 score on a scale
Standard Deviation 2.6
|
4.0 score on a scale
Standard Deviation 2.4
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
Month 6--Foot Care
|
4.4 score on a scale
Standard Deviation 2.2
|
3.9 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Variation in cell sizes due to missing data.
The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked
Yes - Baseline
|
23 Participants
|
23 Participants
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked
Yes - Month 3
|
20 Participants
|
24 Participants
|
|
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked
Yes - Month 6
|
20 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample
The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., "Feeling down, depressed, or hopeless," "Trouble falling or staying asleep, or sleeping too much") over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Patient Health Questionnaire-8 (PHQ-8)
Baseline
|
11.4 score on a scale
Standard Deviation 6.8
|
11.8 score on a scale
Standard Deviation 6.6
|
|
Change in Patient Health Questionnaire-8 (PHQ-8)
Month 3
|
9.3 score on a scale
Standard Deviation 6.5
|
9.7 score on a scale
Standard Deviation 6.1
|
|
Change in Patient Health Questionnaire-8 (PHQ-8)
Month 6
|
9.6 score on a scale
Standard Deviation 6.7
|
9.6 score on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample
The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., "Worrying too much about different things," "Feeling afraid as if something awful might happen") over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
Baseline
|
10.9 units on a scale
Standard Deviation 7.0
|
11.4 units on a scale
Standard Deviation 6.4
|
|
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
Month 3
|
9.3 units on a scale
Standard Deviation 6.8
|
9.3 units on a scale
Standard Deviation 6.7
|
|
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
Month 6
|
9.6 units on a scale
Standard Deviation 6.9
|
9.2 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Full sample
The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community
Outcome measures
| Measure |
iNSPiRED
n=101 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=105 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Use of Community Resources (no to Yes)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 6Population: Full sample
The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA.
Outcome measures
| Measure |
iNSPiRED
n=101 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=105 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Use of VHA Resources (no to Yes)
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample
The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., "I know what each of my prescribed medications do"), skill (e.g., "I have been able to maintain the lifestyle changes for my health that I have made"), and confidence (e.g., "I am confident I can tell my health care provider concerns I have even when he or she does not ask"). Raw scores: Minimum 13. Maximum 52. Scaled scores ("Activation" scores): Minimum 0.0. Maximum 100.0. Higher scores indicate more patient activation.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Patient Activation Measure (PAM)
Baseline
|
55.2 score on a scale
Standard Deviation 14.3
|
53.2 score on a scale
Standard Deviation 12.7
|
|
Change in Patient Activation Measure (PAM)
Month 3
|
60.1 score on a scale
Standard Deviation 15.6
|
56.5 score on a scale
Standard Deviation 12.4
|
|
Change in Patient Activation Measure (PAM)
Month 6
|
59.1 score on a scale
Standard Deviation 15.6
|
56.4 score on a scale
Standard Deviation 13.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a measures self-efficacy related to managing emotions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 24.82 Maximum score 63.45. Higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a
Baseline
|
42.9 T-score
Standard Deviation 4.1
|
43.0 T-score
Standard Deviation 4.1
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a
Month 3
|
43.6 T-score
Standard Deviation 4.5
|
43.7 T-score
Standard Deviation 4.3
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a
Month 6
|
43.5 T-score
Standard Deviation 4.3
|
43.5 T-score
Standard Deviation 3.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a measures self-efficacy related to managing daily activities. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 26.02 Maximum score 59.26. Higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a
Baseline
|
41.9 T-scores
Standard Deviation 3.2
|
41.3 T-scores
Standard Deviation 2.9
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a
Month 3
|
42.5 T-scores
Standard Deviation 3.0
|
41.8 T-scores
Standard Deviation 3.2
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a
Month 6
|
41.9 T-scores
Standard Deviation 3.3
|
41.6 T-scores
Standard Deviation 3.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Month 3, Month 6Population: Full sample; number analyzed in one or more rows differs from the overall number analyzed due to missing data.
PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a measures self-efficacy related to managing social interactions. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Raw scores: Minimum score 4. Maximum score 20. Scaled scores (T-scores with population mean of 50 and a standard deviation of 10): Minimum score 23.08 Maximum score 58.19. Higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
iNSPiRED
n=110 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 Participants
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a
Baseline
|
39.3 T-scores
Standard Deviation 3.9
|
39.8 T-scores
Standard Deviation 4.2
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a
Month 3
|
40.5 T-scores
Standard Deviation 3.9
|
40.6 T-scores
Standard Deviation 4.2
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a
Month 6
|
40.4 T-scores
Standard Deviation 3.5
|
40.2 T-scores
Standard Deviation 4.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and every 12 months assessed up to month 48The investigators will measure stakeholder engagement from the researcher's perspective using a modified version of the PCORI WE-ENACT Researcher Survey, completed annually. One group of researchers (the primary investigator and three team members) involved in stakeholder engagement completed the survey together at each time point. The Outcome Measure Data Table includes the number of participants who completed the survey (1 group of researchers).
Outcome measures
| Measure |
iNSPiRED
n=1 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and every 12 months assessed up to month 48.The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey, completed annually. This measure includes items to describe engagement from the stakeholder's point of view. One or two key representatives from each community partner agency will participate. The Outcome Measure Data Table includes the number of participants who completed the survey.
Outcome measures
| Measure |
iNSPiRED
n=7 Participants
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey
|
7 Participants
|
—
|
Adverse Events
iNSPiRED
Serious events: 12 serious events
Other events: 1 other events
Deaths: 2 deaths
Usual Care
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iNSPiRED
n=110 participants at risk
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 participants at risk
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Vascular disorders
Hospitalization
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.93%
1/108 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Skin and subcutaneous tissue disorders
Death
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.00%
0/108 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Gastrointestinal disorders
Hospitalization
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.93%
1/108 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Cardiac disorders
Hospitalization
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
2.8%
3/108 • Number of events 4 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Cardiac disorders
Death
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.00%
0/108 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
2.8%
3/108 • Number of events 3 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
General disorders
Hospitalization
|
2.7%
3/110 • Number of events 3 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.00%
0/108 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Psychiatric disorders
Hospitalization
|
1.8%
2/110 • Number of events 2 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.00%
0/108 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Metabolism and nutrition disorders
Hospitalization
|
0.00%
0/110 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.93%
1/108 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Nervous system disorders
Hospitalization
|
0.00%
0/110 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.93%
1/108 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
|
Surgical and medical procedures
Hospitalization
|
0.00%
0/110 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.93%
1/108 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
Other adverse events
| Measure |
iNSPiRED
n=110 participants at risk
Peer coaching intervention
iNSPiRED: The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
|
Usual Care
n=108 participants at risk
Directory of resources and encouragement to follow-up with Primary Care Physician
Usual Care: Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
|
|---|---|---|
|
Social circumstances
Homicidal ideation
|
0.91%
1/110 • Number of events 1 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
0.00%
0/108 • Adverse events (AEs) were captured from informed consent through the last follow-up assessment (Month 6) or participant withdrawal.
The following types of events were considered adverse events (AEs) for this minimal-risk study. No other AEs were captured. Specific AE terms were not captured. 1. Marked deterioration in depressed or anxious mood 2. Development of manic or psychotic symptoms 3. Suicidal and homicidal ideation 4. Suicide attempt 5. Incident of violence toward others 6. Hospitalization for acute medical or psychological illness 7. Any other life-threatening or potentially disabling event 8. Death
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place