Trial Outcomes & Findings for Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes (NCT NCT04347291)

Last Updated: 2024-01-17

Results Overview

Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control

Recruitment status

COMPLETED

Study phase

Target enrollment

638 participants

Primary outcome timeframe

Baseline and 6 and 9 months post-baseline

Results posted on

2024-01-17

Participant Flow

We recruited patient participants with a goal of 334 enrolled. Patient participants could invite a support person to enroll with them, but this was not required. 638 represents 338 patient participants and 300 support persons.

9 patient participants were administratively withdrawn prior to randomization; 6 of those participants also had a support person enrolled who was administratively withdrawn. These patient participants were unreachable during a pre-determined run-in period after enrollment and therefore withdrawn per protocol.

Participant milestones

Participant milestones
Measure	FAMS 2.0 Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	Print Materials All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Overall Study STARTED	314	309
Overall Study Patient Participants	164	165
Overall Study Support Persons	150	144
Overall Study COMPLETED	304	297
Overall Study NOT COMPLETED	10	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient participants were randomized with their support person (if enrolled). There were 329 patient participants and 294 support persons (294 patient/support person dyads; 35 patients participated without a support person).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Patient participants

Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Glycemic Control (Patient Participants) During Intervention Period Baseline	8.53 percent Standard Deviation 1.56	8.64 percent Standard Deviation 1.79
Change in Glycemic Control (Patient Participants) During Intervention Period 6 months	8.31 percent Standard Deviation 1.55	8.00 percent Standard Deviation 1.55
Change in Glycemic Control (Patient Participants) During Intervention Period 9 months	8.05 percent Standard Deviation 1.41	8.23 percent Standard Deviation 1.72

PRIMARY outcome

Timeframe: Baseline and 12 and 15 months post-baseline

Population: Patient participants

Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects Baseline	8.53 percent Standard Deviation 1.56	8.64 percent Standard Deviation 1.79
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects 12 months	8.04 percent Standard Deviation 1.41	7.99 percent Standard Deviation 1.55
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects 15 months	8.04 percent Standard Deviation 1.40	8.21 percent Standard Deviation 1.62

PRIMARY outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Patient participants

Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Distress (Patient Participants) During Intervention Period Baseline	38.1 score on a scale Standard Deviation 24.5	38.8 score on a scale Standard Deviation 26.9
Change in Diabetes Distress (Patient Participants) During Intervention Period 6 months	32.9 score on a scale Standard Deviation 24.8	30.1 score on a scale Standard Deviation 25.4
Change in Diabetes Distress (Patient Participants) During Intervention Period 9 months	30.6 score on a scale Standard Deviation 22.8	26.5 score on a scale Standard Deviation 25.4

PRIMARY outcome

Timeframe: Baseline and 15 months post-baseline

Population: Patient participants

Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect Baseline	38.1 score on a scale Standard Deviation 24.5	38.8 score on a scale Standard Deviation 26.9
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect 15 months	27.8 score on a scale Standard Deviation 22.4	26.2 score on a scale Standard Deviation 25.5

PRIMARY outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Patient participants

Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Psychosocial Well-being (Patient Participants) During Intervention Period Baseline	56.5 score on a scale Standard Deviation 23.1	55.6 score on a scale Standard Deviation 23.4
Change in Psychosocial Well-being (Patient Participants) During Intervention Period 6 months	57.5 score on a scale Standard Deviation 22.9	62.5 score on a scale Standard Deviation 23.2
Change in Psychosocial Well-being (Patient Participants) During Intervention Period 9 months	61.4 score on a scale Standard Deviation 22.2	62.2 score on a scale Standard Deviation 22.2

PRIMARY outcome

Timeframe: Baseline and15 months post-baseline

Population: Patient participants

Assessed by the World Health Organization - Five Well-Being Index (WHO-5) with scores ranging 0 to 100 where higher scores indicate more well-being (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect Baseline	56.5 score on a scale Standard Deviation 23.1	55.6 score on a scale Standard Deviation 23.4
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect 15 months	65.3 score on a scale Standard Deviation 23.0	62.0 score on a scale Standard Deviation 23.1

SECONDARY outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Support person participants

as assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 where higher scores indicate more diabetes distress experienced by the support person (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Distress (Support Person Participants) During Intervention Period Baseline	31.4 score on a scale Standard Deviation 21.6	34.2 score on a scale Standard Deviation 22.2
Change in Diabetes Distress (Support Person Participants) During Intervention Period 6 months	28.4 score on a scale Standard Deviation 20.1	31.9 score on a scale Standard Deviation 22.4
Change in Diabetes Distress (Support Person Participants) During Intervention Period 9 months	28.3 score on a scale Standard Deviation 22.2	30.2 score on a scale Standard Deviation 21.8

SECONDARY outcome

Timeframe: Baseline and 15 months post-baseline

Population: Support person participants

Assessed by the Problem Areas in Diabetes (PAID-5) Family Member Version. Scores range 0-100 with higher scores indicate more diabetes distress experienced by the support person (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect Baseline	31.4 score on a scale Standard Deviation 21.6	34.2 score on a scale Standard Deviation 22.2
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect 15 months	27.8 score on a scale Standard Deviation 20.7	28.9 score on a scale Standard Deviation 22.5

SECONDARY outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Support person participants

as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where higher scores indicate greater support burden (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Support Burden (Support Person Participants) During Intervention Period Baseline	0.360 score on a scale Standard Deviation 0.674	0.392 score on a scale Standard Deviation 0.760
Change in Support Burden (Support Person Participants) During Intervention Period 6 months	0.368 score on a scale Standard Deviation 0.746	0.341 score on a scale Standard Deviation 0.690
Change in Support Burden (Support Person Participants) During Intervention Period 9 months	0.366 score on a scale Standard Deviation 0.716	0.392 score on a scale Standard Deviation 0.710

SECONDARY outcome

Timeframe: Baseline and 15 months post-baseline

Population: Support person participants

as assessed by the Impact of Diabetes Profile-Family Members from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 100 where higher scores indicate greater support burden (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect Baseline	0.360 score on a scale Standard Deviation 0.674	0.392 score on a scale Standard Deviation 0.760
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect 15 months	0.368 score on a scale Standard Deviation 0.750	0.301 score on a scale Standard Deviation 0.664

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6 and 9 months post-baseline

Population: Patient participants

as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) Baseline	25.0 score on a scale Standard Deviation 6.41	25.7 score on a scale Standard Deviation 6.74
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) 6 months	26.4 score on a scale Standard Deviation 6.74	29.6 score on a scale Standard Deviation 6.85
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) 9 months	27.8 score on a scale Standard Deviation 6.50	30.2 score on a scale Standard Deviation 6.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by Personal Diabetes Questionnaire, Use of Information for Decision Making Scale with scores ranging 1-6 where higher scores indicate more use of dietary information for decision making (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) Baseline	3.15 score on a scale Standard Deviation 1.48	3.00 score on a scale Standard Deviation 1.53
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 6 months	3.40 score on a scale Standard Deviation 1.45	3.43 score on a scale Standard Deviation 1.61
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 9 months	3.37 score on a scale Standard Deviation 1.43	3.64 score on a scale Standard Deviation 1.49
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 15 months	3.31 score on a scale Standard Deviation 1.42	3.30 score on a scale Standard Deviation 1.43

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) Baseline	3.78 score on a scale Standard Deviation 0.983	3.73 score on a scale Standard Deviation 1.09
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 6 months	3.58 score on a scale Standard Deviation 1.01	3.23 score on a scale Standard Deviation 0.898
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 9 months	3.43 score on a scale Standard Deviation 1.07	3.19 score on a scale Standard Deviation 0.919
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) 15 months	3.44 score on a scale Standard Deviation 1.08	3.29 score on a scale Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Physical Activity (Patient Participants - Outcome & Mediator) Baseline	830 score on a scale Standard Deviation 969	670 score on a scale Standard Deviation 840
Change in Physical Activity (Patient Participants - Outcome & Mediator) 6 months	782 score on a scale Standard Deviation 982	873 score on a scale Standard Deviation 943
Change in Physical Activity (Patient Participants - Outcome & Mediator) 9 months	789 score on a scale Standard Deviation 1020	890 score on a scale Standard Deviation 1146
Change in Physical Activity (Patient Participants - Outcome & Mediator) 15 months	777 score on a scale Standard Deviation 941	782 score on a scale Standard Deviation 957

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the Summary of Diabetes Self-Care Activities medications subscale with scores ranging 0 to 7 representing days in the prior week with perfect adherence (higher better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) Baseline	6.22 score on a scale Standard Deviation 1.48	6.22 score on a scale Standard Deviation 1.55
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 6 months	6.38 score on a scale Standard Deviation 1.46	6.56 score on a scale Standard Deviation 1.12
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 9 months	6.29 score on a scale Standard Deviation 1.54	6.39 score on a scale Standard Deviation 1.57
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 15 months	6.48 score on a scale Standard Deviation 1.14	6.44 score on a scale Standard Deviation 1.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the Adherence to Refills and Medications in Diabetes scale, with scores ranging 11-44 with higher scores indicating more problems with adherence (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) Baseline	14.9 score on a scale Standard Deviation 3.36	15.3 score on a scale Standard Deviation 4.38
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 6 months	14.3 score on a scale Standard Deviation 3.27	13.9 score on a scale Standard Deviation 3.41
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 9 months	14.3 score on a scale Standard Deviation 3.66	13.7 score on a scale Standard Deviation 3.20
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) 15 months	14.2 score on a scale Standard Deviation 3.87	14.1 score on a scale Standard Deviation 3.75

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) Baseline	2.27 score on a scale Standard Deviation 1.04	2.33 score on a scale Standard Deviation 1.04
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 6 months	2.28 score on a scale Standard Deviation 1.07	2.86 score on a scale Standard Deviation 1.06
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 9 months	2.33 score on a scale Standard Deviation 1.01	2.74 score on a scale Standard Deviation 1.14
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 15 months	2.34 score on a scale Standard Deviation 1.06	2.48 score on a scale Standard Deviation 1.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the Important Others Climate Questionnaire, specific to diabetes management, with scores ranging 1 to 5 with higher scores indicating more autonomy supportive communication (better)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) Baseline	3.50 score on a scale Standard Deviation 0.871	3.45 score on a scale Standard Deviation 0.870
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 6 months	3.58 score on a scale Standard Deviation 0.961	3.81 score on a scale Standard Deviation 0.804
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 9 months	3.58 score on a scale Standard Deviation 0.947	3.79 score on a scale Standard Deviation 0.865
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 15 months	3.49 score on a scale Standard Deviation 0.962	3.66 score on a scale Standard Deviation 0.954

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes with scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) Baseline	1.67 score on a scale Standard Deviation 0.630	1.66 score on a scale Standard Deviation 0.547
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 6 months	1.62 score on a scale Standard Deviation 0.621	1.62 score on a scale Standard Deviation 0.588
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 9 months	1.55 score on a scale Standard Deviation 0.532	1.53 score on a scale Standard Deviation 0.589
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 15 months	1.60 score on a scale Standard Deviation 0.649	1.54 score on a scale Standard Deviation 0.516

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Patient participants

as assessed by the criticism items from the Family Emotional Involvement and Criticism Scale, specific to diabetes management, with scores ranging 0 to 16 with higher scores indicating more perceived criticism (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=165 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=164 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) Baseline	3.52 score on a scale Standard Deviation 3.42	4.15 score on a scale Standard Deviation 4.06
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 6 months	3.11 score on a scale Standard Deviation 3.40	3.26 score on a scale Standard Deviation 3.59
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 9 months	2.82 score on a scale Standard Deviation 3.30	3.00 score on a scale Standard Deviation 3.57
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) 15 months	3.10 score on a scale Standard Deviation 3.56	2.87 score on a scale Standard Deviation 3.28

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Support person participants

as assessed by the Helpful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more helpful involvement (better)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) Baseline	2.53 score on a scale Standard Deviation 1.03	2.66 score on a scale Standard Deviation 0.946
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) 6 months	2.47 score on a scale Standard Deviation 0.947	3.11 score on a scale Standard Deviation 1.01
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) 9 months	2.49 score on a scale Standard Deviation 0.997	3.04 score on a scale Standard Deviation 0.988
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) 15 months	2.37 score on a scale Standard Deviation 0.921	2.74 score on a scale Standard Deviation 0.974

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Support person participants

as assessed by the Harmful Involvement scale of Family/friend Involvement in Adults' Diabetes - support person version. Scores ranging 1 to 5 with higher scores indicating more harmful involvement (worse)

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) Baseline	1.49 score on a scale Standard Deviation 0.492	1.50 score on a scale Standard Deviation 0.439
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) 6 months	1.38 score on a scale Standard Deviation 0.453	1.38 score on a scale Standard Deviation 0.448
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) 9 months	1.39 score on a scale Standard Deviation 0.472	1.39 score on a scale Standard Deviation 0.472
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) 15 months	1.35 score on a scale Standard Deviation 0.443	1.37 score on a scale Standard Deviation 0.368

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and 6, 9, and 15 months post-baseline

Population: Support person participants

as assessed by items from the Family Experience of Patient Involvement measure from the Diabetes Attitudes Wishes and Needs Study-2 (DAWN2). Scores range 0 to 4 where a score of 2 indicates alignment between the support person's current level of involvement and their desired level of involvement. We will report change in the % aligned (reporting a 2) across conditions.

Outcome measures

Outcome measures
Measure	Print Materials n=144 Participants All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.	FAMS 2.0 n=150 Participants Patient participants will receive FAMS 2.0 components (monthly phone coaching and text message support for goals and medication adherence) for nine months. Linked support persons will receive text message support tailored to the goal set by the patient participant. All patient participants will receive text messages advising how to access their study A1c test results, and receive high-quality print materials including a book upon enrollment and quarterly newsletters on healthy living with diabetes. All support person participants will receive high-quality print materials including a book and information about providing quality social support upon enrollment and quarterly newsletters on healthy living with diabetes. FAMS 2.0: FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled. Print Materials: Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) Baseline	44 Participants	46 Participants
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) 6 months	70 Participants	67 Participants
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) 9 months	65 Participants	65 Participants
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) 15 months	69 Participants	65 Participants

Adverse Events

FAMS 2.0-Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

FAMS 2.0-Support Persons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Print Materials-Patient Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Print Materials-Support Persons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lindsay Mayberry

Vanderbilt University Medical Center

Phone: 615-875-5821

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place