Type 2 Diabetes
Conditions
Keywords
family support, social support, text message, mobile health, hemoglobin A1c
Brief summary
This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.
Detailed description
The 9-month FAMS 2.0 intervention is an expansion and improvement of a previously evaluated intervention (FAMS; NCT02481596). FAMS components include: * Monthly coaching sessions (20-30 minutes each) with patient participants by phone focusing on helpful/unhelpful/desired family and friend behaviors relevant to the patients' self-identified diet, exercise, and/or stress management goal * Daily one-way and interactive text messages to the patient to support him/her in meeting the identified daily goal and medication adherence * Weekly interactive text messages asking the patient to reflect on goal progress followed by personalized feedback from the coach * The option to invite an adult support person to receive text messages (3 one-way per week and one interactive text per week) encouraging the support person to discuss the patient's self-care goal to provide opportunities for the patient to practice skills discussed during phone coaching Participants will be randomized in a parallel design to either FAMS 2.0 or an active control. Our target enrollment is N=334 dyads (patient participants and support persons). Patients are encouraged to invite a support person, but it is not required. Patients and their support person will be randomized together (if enrolled). The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects at 9 months (post-intervention) and 15 months (sustained effects). The investigators will impute missing data, including all participants completing at least two data collection periods in analyses. Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals).
Interventions
BEHAVIORALFAMS 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.
BEHAVIORALPrint Materials
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The investigators use mail-in A1c kits for the primary outcome - hemoglobin A1c - and the lab analyzing these samples is masked to study description or participants' assigned condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
PATIENTS: * Speaks and reads in English * 18-75 years old * Diagnosed with type 2 diabetes * Receiving outpatient care from a partnering clinic * Community dwelling (e.g., not in a nursing facility) * Prescribed at least one daily diabetes medication * Owns a mobile phone SUPPORT PERSONS: * Speaks and reads in English * 18 years or older * Owns a mobile phone
Exclusion criteria
PATIENTS: * Unable to communicate by phone * Pregnant currently * Currently undergoing treatment for cancer (e.g., radiation, chemotherapy) * Diagnosed with end-stage renal disease * Receiving hospice services * Diagnosed with congestive heart failure * Diagnosed with dementia * Diagnosed with schizophrenia * Reported current abuse during screening * Demonstrates inability to receive and respond to a text * Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS: \- Demonstrates inability to receive and respond to a text
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycemic Control (Patient Participants) During Intervention Period | Baseline and 6 and 9 months post-baseline | 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 |
| Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | Baseline and15 months post-baseline | 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) |
| Change in Psychosocial Well-being (Patient Participants) During Intervention Period | Baseline and 6 and 9 months post-baseline | 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) |
| Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | Baseline and 15 months post-baseline | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) |
| Change in Diabetes Distress (Patient Participants) During Intervention Period | Baseline and 6 and 9 months post-baseline | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more distress (worse) |
| Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | Baseline and 12 and 15 months post-baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Distress (Support Person Participants) During Intervention Period | Baseline and 6 and 9 months post-baseline | 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) |
| Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | Baseline and 15 months post-baseline | 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) |
| Change in Support Burden (Support Person Participants) During Intervention Period | Baseline and 6 and 9 months post-baseline | 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) |
| Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | Baseline and 15 months post-baseline | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Physical Activity (Patient Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | as assessed by a modified Rapid Assessment of Physical Activity with scores ranging 0 to 6533 with higher scores indicating more physical activity (better) |
| Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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) |
| Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | Baseline and 6, 9, and 15 months post-baseline | 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. |
| Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | Baseline and 6 and 9 months post-baseline | as assessed by the Perceived Diabetes Self-Management Scale with scores ranging 8 to 40 with higher scores indicating more self-efficacy (better) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 314 |
| 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. | 309 |
| Total | 623 |
Baseline characteristics
| Characteristic | FAMS 2.0 | Print Materials | Total |
|---|---|---|---|
| Age, Continuous Patient participants | 56.1 years STANDARD_DEVIATION 11 | 57.9 years STANDARD_DEVIATION 10.5 | 57.0 years STANDARD_DEVIATION 10.8 |
| Age, Continuous Support persons | 50.4 years STANDARD_DEVIATION 14.7 | 53.4 years STANDARD_DEVIATION 14 | 51.9 years STANDARD_DEVIATION 14.4 |
| Diabetes distress (patient participants) | 38.8 score on a scale STANDARD_DEVIATION 26.9 | 38.1 score on a scale STANDARD_DEVIATION 24.5 | 38.5 score on a scale STANDARD_DEVIATION 25.7 |
| Ethnicity (NIH/OMB) Patient participants Hispanic or Latino | 13 Participants | 12 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Patient participants Not Hispanic or Latino | 151 Participants | 152 Participants | 303 Participants |
| Ethnicity (NIH/OMB) Patient participants Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Support persons Hispanic or Latino | 8 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Support persons Not Hispanic or Latino | 135 Participants | 132 Participants | 267 Participants |
| Ethnicity (NIH/OMB) Support persons Unknown or Not Reported | 7 Participants | 6 Participants | 13 Participants |
| Hemoglobin A1c (patient participants) | 8.64 percent STANDARD_DEVIATION 1.79 | 8.53 percent STANDARD_DEVIATION 1.56 | 8.59 percent STANDARD_DEVIATION 1.68 |
| Psychosocial well-being (patient participants) | 55.6 score on a scale STANDARD_DEVIATION 23.4 | 56.5 score on a scale STANDARD_DEVIATION 23.1 | 56.1 score on a scale STANDARD_DEVIATION 23.2 |
| Race (NIH/OMB) Patient participants American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient participants Asian | 8 Participants | 8 Participants | 16 Participants |
| Race (NIH/OMB) Patient participants Black or African American | 35 Participants | 44 Participants | 79 Participants |
| Race (NIH/OMB) Patient participants More than one race | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Patient participants Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Patient participants Unknown or Not Reported | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) Patient participants White | 115 Participants | 105 Participants | 220 Participants |
| Race (NIH/OMB) Support persons American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Support persons Asian | 8 Participants | 6 Participants | 14 Participants |
| Race (NIH/OMB) Support persons Black or African American | 30 Participants | 36 Participants | 66 Participants |
| Race (NIH/OMB) Support persons More than one race | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Support persons Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Support persons Unknown or Not Reported | 9 Participants | 8 Participants | 17 Participants |
| Race (NIH/OMB) Support persons White | 97 Participants | 92 Participants | 189 Participants |
| Sex/Gender, Customized Patient participants Female | 77 Participants | 80 Participants | 157 Participants |
| Sex/Gender, Customized Patient participants Male | 85 Participants | 85 Participants | 170 Participants |
| Sex/Gender, Customized Patient participants Prefer to self-describe | 2 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Patient participants Unknown or not reported | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Support persons Female | 102 Participants | 103 Participants | 205 Participants |
| Sex/Gender, Customized Support persons Male | 42 Participants | 38 Participants | 80 Participants |
| Sex/Gender, Customized Support persons Prefer to self-describe | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Support persons Unknown or not reported | 6 Participants | 3 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 164 | 0 / 150 | 2 / 165 | 0 / 144 |
| other Total, other adverse events | 0 / 164 | 0 / 150 | 0 / 165 | 0 / 144 |
| serious Total, serious adverse events | 0 / 164 | 0 / 150 | 0 / 165 | 0 / 144 |
Outcome results
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)
Time frame: Baseline and 6 and 9 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Distress (Patient Participants) During Intervention Period | Baseline | 38.8 score on a scale | Standard Deviation 26.9 |
| FAMS 2.0 | Change in Diabetes Distress (Patient Participants) During Intervention Period | 6 months | 30.1 score on a scale | Standard Deviation 25.4 |
| FAMS 2.0 | Change in Diabetes Distress (Patient Participants) During Intervention Period | 9 months | 26.5 score on a scale | Standard Deviation 25.4 |
| Print Materials | Change in Diabetes Distress (Patient Participants) During Intervention Period | Baseline | 38.1 score on a scale | Standard Deviation 24.5 |
| Print Materials | Change in Diabetes Distress (Patient Participants) During Intervention Period | 6 months | 32.9 score on a scale | Standard Deviation 24.8 |
| Print Materials | Change in Diabetes Distress (Patient Participants) During Intervention Period | 9 months | 30.6 score on a scale | Standard Deviation 22.8 |
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)
Time frame: Baseline and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | Baseline | 38.8 score on a scale | Standard Deviation 26.9 |
| FAMS 2.0 | Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | 15 months | 26.2 score on a scale | Standard Deviation 25.5 |
| Print Materials | Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | Baseline | 38.1 score on a scale | Standard Deviation 24.5 |
| Print Materials | Change in Diabetes Distress (Patient Participants) Sustained Post-intervention Effect | 15 months | 27.8 score on a scale | Standard Deviation 22.4 |
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
Time frame: Baseline and 6 and 9 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) During Intervention Period | Baseline | 8.64 percent | Standard Deviation 1.79 |
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) During Intervention Period | 6 months | 8.00 percent | Standard Deviation 1.55 |
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) During Intervention Period | 9 months | 8.23 percent | Standard Deviation 1.72 |
| Print Materials | Change in Glycemic Control (Patient Participants) During Intervention Period | Baseline | 8.53 percent | Standard Deviation 1.56 |
| Print Materials | Change in Glycemic Control (Patient Participants) During Intervention Period | 6 months | 8.31 percent | Standard Deviation 1.55 |
| Print Materials | Change in Glycemic Control (Patient Participants) During Intervention Period | 9 months | 8.05 percent | Standard Deviation 1.41 |
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
Time frame: Baseline and 12 and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | Baseline | 8.64 percent | Standard Deviation 1.79 |
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | 12 months | 7.99 percent | Standard Deviation 1.55 |
| FAMS 2.0 | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | 15 months | 8.21 percent | Standard Deviation 1.62 |
| Print Materials | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | Baseline | 8.53 percent | Standard Deviation 1.56 |
| Print Materials | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | 12 months | 8.04 percent | Standard Deviation 1.41 |
| Print Materials | Change in Glycemic Control (Patient Participants) Sustained Post-intervention Effects | 15 months | 8.04 percent | Standard Deviation 1.4 |
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)
Time frame: Baseline and 6 and 9 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | Baseline | 55.6 score on a scale | Standard Deviation 23.4 |
| FAMS 2.0 | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | 6 months | 62.5 score on a scale | Standard Deviation 23.2 |
| FAMS 2.0 | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | 9 months | 62.2 score on a scale | Standard Deviation 22.2 |
| Print Materials | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | Baseline | 56.5 score on a scale | Standard Deviation 23.1 |
| Print Materials | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | 6 months | 57.5 score on a scale | Standard Deviation 22.9 |
| Print Materials | Change in Psychosocial Well-being (Patient Participants) During Intervention Period | 9 months | 61.4 score on a scale | Standard Deviation 22.2 |
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)
Time frame: Baseline and15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | Baseline | 55.6 score on a scale | Standard Deviation 23.4 |
| FAMS 2.0 | Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | 15 months | 62.0 score on a scale | Standard Deviation 23.1 |
| Print Materials | Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | Baseline | 56.5 score on a scale | Standard Deviation 23.1 |
| Print Materials | Change in Psychosocial Well-being (Patient Participants) Sustained Post-intervention Effect | 15 months | 65.3 score on a scale | Standard Deviation 23 |
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)
Time frame: Baseline and 6 and 9 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Distress (Support Person Participants) During Intervention Period | Baseline | 34.2 score on a scale | Standard Deviation 22.2 |
| FAMS 2.0 | Change in Diabetes Distress (Support Person Participants) During Intervention Period | 6 months | 31.9 score on a scale | Standard Deviation 22.4 |
| FAMS 2.0 | Change in Diabetes Distress (Support Person Participants) During Intervention Period | 9 months | 30.2 score on a scale | Standard Deviation 21.8 |
| Print Materials | Change in Diabetes Distress (Support Person Participants) During Intervention Period | Baseline | 31.4 score on a scale | Standard Deviation 21.6 |
| Print Materials | Change in Diabetes Distress (Support Person Participants) During Intervention Period | 6 months | 28.4 score on a scale | Standard Deviation 20.1 |
| Print Materials | Change in Diabetes Distress (Support Person Participants) During Intervention Period | 9 months | 28.3 score on a scale | Standard Deviation 22.2 |
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)
Time frame: Baseline and 15 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | Baseline | 34.2 score on a scale | Standard Deviation 22.2 |
| FAMS 2.0 | Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | 15 months | 28.9 score on a scale | Standard Deviation 22.5 |
| Print Materials | Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | Baseline | 31.4 score on a scale | Standard Deviation 21.6 |
| Print Materials | Change in Diabetes Distress (Support Person Participants) Sustained Post-intervention Effect | 15 months | 27.8 score on a scale | Standard Deviation 20.7 |
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)
Time frame: Baseline and 6 and 9 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Support Burden (Support Person Participants) During Intervention Period | Baseline | 0.392 score on a scale | Standard Deviation 0.76 |
| FAMS 2.0 | Change in Support Burden (Support Person Participants) During Intervention Period | 6 months | 0.341 score on a scale | Standard Deviation 0.69 |
| FAMS 2.0 | Change in Support Burden (Support Person Participants) During Intervention Period | 9 months | 0.392 score on a scale | Standard Deviation 0.71 |
| Print Materials | Change in Support Burden (Support Person Participants) During Intervention Period | Baseline | 0.360 score on a scale | Standard Deviation 0.674 |
| Print Materials | Change in Support Burden (Support Person Participants) During Intervention Period | 6 months | 0.368 score on a scale | Standard Deviation 0.746 |
| Print Materials | Change in Support Burden (Support Person Participants) During Intervention Period | 9 months | 0.366 score on a scale | Standard Deviation 0.716 |
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)
Time frame: Baseline and 15 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | Baseline | 0.392 score on a scale | Standard Deviation 0.76 |
| FAMS 2.0 | Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | 15 months | 0.301 score on a scale | Standard Deviation 0.664 |
| Print Materials | Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | Baseline | 0.360 score on a scale | Standard Deviation 0.674 |
| Print Materials | Change in Support Burden (Support Person Participants) Sustained Post-intervention Effect | 15 months | 0.368 score on a scale | Standard Deviation 0.75 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | Baseline | 15.3 score on a scale | Standard Deviation 4.38 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 6 months | 13.9 score on a scale | Standard Deviation 3.41 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 9 months | 13.7 score on a scale | Standard Deviation 3.2 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 15 months | 14.1 score on a scale | Standard Deviation 3.75 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 15 months | 14.2 score on a scale | Standard Deviation 3.87 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | Baseline | 14.9 score on a scale | Standard Deviation 3.36 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 9 months | 14.3 score on a scale | Standard Deviation 3.66 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 6 months | 14.3 score on a scale | Standard Deviation 3.27 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | Baseline | 6.22 score on a scale | Standard Deviation 1.55 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 6 months | 6.56 score on a scale | Standard Deviation 1.12 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 9 months | 6.39 score on a scale | Standard Deviation 1.57 |
| FAMS 2.0 | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 15 months | 6.44 score on a scale | Standard Deviation 1.33 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 15 months | 6.48 score on a scale | Standard Deviation 1.14 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | Baseline | 6.22 score on a scale | Standard Deviation 1.48 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 9 months | 6.29 score on a scale | Standard Deviation 1.54 |
| Print Materials | Change in Diabetes Medication Adherence (Patient Participants - Outcome & Mediator) | 6 months | 6.38 score on a scale | Standard Deviation 1.46 |
Other Pre-specified
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)
Time frame: Baseline and 6 and 9 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | Baseline | 25.7 score on a scale | Standard Deviation 6.74 |
| FAMS 2.0 | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | 6 months | 29.6 score on a scale | Standard Deviation 6.85 |
| FAMS 2.0 | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | 9 months | 30.2 score on a scale | Standard Deviation 6.65 |
| Print Materials | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | Baseline | 25.0 score on a scale | Standard Deviation 6.41 |
| Print Materials | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | 6 months | 26.4 score on a scale | Standard Deviation 6.74 |
| Print Materials | Change in Diabetes Self-efficacy (Patient Participants - Outcome & Mediator) | 9 months | 27.8 score on a scale | Standard Deviation 6.5 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | Baseline | 3.00 score on a scale | Standard Deviation 1.53 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 6 months | 3.43 score on a scale | Standard Deviation 1.61 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 9 months | 3.64 score on a scale | Standard Deviation 1.49 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 15 months | 3.30 score on a scale | Standard Deviation 1.43 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 15 months | 3.31 score on a scale | Standard Deviation 1.42 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | Baseline | 3.15 score on a scale | Standard Deviation 1.48 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 9 months | 3.37 score on a scale | Standard Deviation 1.43 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 6 months | 3.40 score on a scale | Standard Deviation 1.45 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | Baseline | 3.73 score on a scale | Standard Deviation 1.09 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 6 months | 3.23 score on a scale | Standard Deviation 0.898 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 9 months | 3.19 score on a scale | Standard Deviation 0.919 |
| FAMS 2.0 | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 15 months | 3.29 score on a scale | Standard Deviation 1.02 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 15 months | 3.44 score on a scale | Standard Deviation 1.08 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | Baseline | 3.78 score on a scale | Standard Deviation 0.983 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 9 months | 3.43 score on a scale | Standard Deviation 1.07 |
| Print Materials | Change in Dietary Behavior (Patient Participants - Outcome & Mediator) | 6 months | 3.58 score on a scale | Standard Deviation 1.01 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 1.66 score on a scale | Standard Deviation 0.547 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 1.62 score on a scale | Standard Deviation 0.588 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 1.53 score on a scale | Standard Deviation 0.589 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 1.54 score on a scale | Standard Deviation 0.516 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 1.60 score on a scale | Standard Deviation 0.649 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 1.67 score on a scale | Standard Deviation 0.63 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 1.55 score on a scale | Standard Deviation 0.532 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 1.62 score on a scale | Standard Deviation 0.621 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 4.15 score on a scale | Standard Deviation 4.06 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 3.26 score on a scale | Standard Deviation 3.59 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 3.00 score on a scale | Standard Deviation 3.57 |
| FAMS 2.0 | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 2.87 score on a scale | Standard Deviation 3.28 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 3.10 score on a scale | Standard Deviation 3.56 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 3.52 score on a scale | Standard Deviation 3.42 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 2.82 score on a scale | Standard Deviation 3.3 |
| Print Materials | Change in Harmful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 3.11 score on a scale | Standard Deviation 3.4 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline | 1.50 score on a scale | Standard Deviation 0.439 |
| FAMS 2.0 | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 6 months | 1.38 score on a scale | Standard Deviation 0.448 |
| FAMS 2.0 | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 9 months | 1.39 score on a scale | Standard Deviation 0.472 |
| FAMS 2.0 | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 15 months | 1.37 score on a scale | Standard Deviation 0.368 |
| Print Materials | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 15 months | 1.35 score on a scale | Standard Deviation 0.443 |
| Print Materials | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline | 1.49 score on a scale | Standard Deviation 0.492 |
| Print Materials | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 9 months | 1.39 score on a scale | Standard Deviation 0.472 |
| Print Materials | Change in Harmful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 6 months | 1.38 score on a scale | Standard Deviation 0.453 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 2.33 score on a scale | Standard Deviation 1.04 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 2.86 score on a scale | Standard Deviation 1.06 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 2.74 score on a scale | Standard Deviation 1.14 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 2.48 score on a scale | Standard Deviation 1.05 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 2.34 score on a scale | Standard Deviation 1.06 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 2.27 score on a scale | Standard Deviation 1.04 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 2.33 score on a scale | Standard Deviation 1.01 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 2.28 score on a scale | Standard Deviation 1.07 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 3.45 score on a scale | Standard Deviation 0.87 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 3.81 score on a scale | Standard Deviation 0.804 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 3.79 score on a scale | Standard Deviation 0.865 |
| FAMS 2.0 | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 3.66 score on a scale | Standard Deviation 0.954 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 15 months | 3.49 score on a scale | Standard Deviation 0.962 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | Baseline | 3.50 score on a scale | Standard Deviation 0.871 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 9 months | 3.58 score on a scale | Standard Deviation 0.947 |
| Print Materials | Change in Helpful Diabetes-specific Family/Friend Involvement (Patient Participants - Outcome & Mediator) | 6 months | 3.58 score on a scale | Standard Deviation 0.961 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline | 2.66 score on a scale | Standard Deviation 0.946 |
| FAMS 2.0 | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 6 months | 3.11 score on a scale | Standard Deviation 1.01 |
| FAMS 2.0 | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 9 months | 3.04 score on a scale | Standard Deviation 0.988 |
| FAMS 2.0 | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 15 months | 2.74 score on a scale | Standard Deviation 0.974 |
| Print Materials | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 15 months | 2.37 score on a scale | Standard Deviation 0.921 |
| Print Materials | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | Baseline | 2.53 score on a scale | Standard Deviation 1.03 |
| Print Materials | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 9 months | 2.49 score on a scale | Standard Deviation 0.997 |
| Print Materials | Change in Helpful Support Person Involvement (Support Person Participants - Outcome & Mediator) | 6 months | 2.47 score on a scale | Standard Deviation 0.947 |
Other Pre-specified
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)
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Patient participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FAMS 2.0 | Change in Physical Activity (Patient Participants - Outcome & Mediator) | Baseline | 670 score on a scale | Standard Deviation 840 |
| FAMS 2.0 | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 6 months | 873 score on a scale | Standard Deviation 943 |
| FAMS 2.0 | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 9 months | 890 score on a scale | Standard Deviation 1146 |
| FAMS 2.0 | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 15 months | 782 score on a scale | Standard Deviation 957 |
| Print Materials | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 15 months | 777 score on a scale | Standard Deviation 941 |
| Print Materials | Change in Physical Activity (Patient Participants - Outcome & Mediator) | Baseline | 830 score on a scale | Standard Deviation 969 |
| Print Materials | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 9 months | 789 score on a scale | Standard Deviation 1020 |
| Print Materials | Change in Physical Activity (Patient Participants - Outcome & Mediator) | 6 months | 782 score on a scale | Standard Deviation 982 |
Other Pre-specified
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.
Time frame: Baseline and 6, 9, and 15 months post-baseline
Population: Support person participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FAMS 2.0 | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | Baseline | 46 Participants |
| FAMS 2.0 | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 6 months | 67 Participants |
| FAMS 2.0 | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 9 months | 65 Participants |
| FAMS 2.0 | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 15 months | 65 Participants |
| Print Materials | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 15 months | 69 Participants |
| Print Materials | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | Baseline | 44 Participants |
| Print Materials | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 9 months | 65 Participants |
| Print Materials | Change in Support Person Involvement Alignment (Support Person Participants - Outcome & Mediator) | 6 months | 70 Participants |