Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) |
as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better) |
Baseline and 6 and 9 months post-baseline |
|
| Other |
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Dietary Behavior (Patient Participants - Outcome & Mediator) |
as assessed by Personal Diabetes Questionnaire, Problem Eating Behavior scale with scores ranging 1-6 where higher scores indicate more problem eating behaviors (worse) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Physical Activity (Patient Participants - Outcome & Mediator) |
as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) |
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) |
Baseline and 6, 9, and 15 months post-baseline |
|
| Other |
Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) |
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. |
Baseline and 6, 9, and 15 months post-baseline |
|
| Primary |
Change in Glycemic Control (Patient Participants) During Intervention Period |
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 |
Baseline and 6 and 9 months post-baseline |
|
| Primary |
Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects |
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 |
Baseline and 12 and 15 months post-baseline |
|
| Primary |
Change in Diabetes Distress (Patient Participants) During Intervention Period |
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) |
Baseline and 6 and 9 months post-baseline |
|
| Primary |
Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect |
Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) |
Baseline and 15 months post-baseline |
|
| Primary |
Change in Psychosocial Well-being (Patient Participants) During Intervention Period |
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) |
Baseline and 6 and 9 months post-baseline |
|
| Primary |
Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect |
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) |
Baseline and15 months post-baseline |
|
| Secondary |
Change in Diabetes Distress (Support Person Participants) During Intervention Period |
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) |
Baseline and 6 and 9 months post-baseline |
|
| Secondary |
Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect |
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) |
Baseline and 15 months post-baseline |
|
| Secondary |
Change in Support Burden (Support Person Participants) During Intervention Period |
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) |
Baseline and 6 and 9 months post-baseline |
|
| Secondary |
Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect |
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) |
Baseline and 15 months post-baseline |
|
