Type 2 Diabetes
Conditions
Keywords
family support, social support, text message, mobile health, hemoglobin A1c
Brief summary
This behavioral clinical trial evaluates an adaptively tailored, mobile phone-delivered intervention (MOSAIC) designed to support adults managing their type 2 diabetes. Adaptive means the intervention can change over time. Tailored means the intervention may be different for different participants. The main questions the study will aim to answer are: 1. Does the diabetes education and support delivered via the MOSAIC adaptive mobile phone-delivered intervention improve outcomes more than diabetes education and support delivered via print materials alone? This aim compares the study arms on outcomes such as glycemic management (hemoglobin A1c), diabetes distress, and psychosocial well-being. This aim also compares the study arms on intervention targets (mediators) including diabetes self-efficacy and self-care behaviors. 2. For whom does the MOSAIC adaptive tailoring approach improve outcomes more than the print materials alone? This aim examines how well the tailoring rules used for the MOSAIC intervention worked for different participants on the outcomes examined in the first aim. Participants will enroll in a 16-month study with assessments every 4 months. Assessments include completion of an A1c test and a survey. For those assigned to MOSAIC, they will experience 12-months of mobile phone-delivered support with 3 opportunities for intervention tailoring.
Detailed description
MOSAIC intervention components include: * Monthly coaching sessions (\ 30 minutes each) - Persons with diabetes (PWD) will engage in goal setting and skill building relevant to their self-identified diet, exercise, and/or stress management goal * Daily one-way and interactive text messages to support the PWD in meeting their goal and supporting medication adherence * Weekly interactive text messages asking the PWD to reflect on goal progress followed by personalized feedback from their coach * The option to invite an adult support person (SP). SPs may be invited to participate in monthly phone coaching and/or receive text messages (3 one-way texts per week and one interactive text per week) pertaining to supporting the PWD, per the MOSAIC intervention adaptive tailoring rules PWD participants will be randomized in a parallel design to the MOSAIC adaptive mobile phone-delivered intervention or to print materials alone. The study is powered to detect a 0.5% reduction in hemoglobin A1c. Analyses will examine effects during the intervention (4 and 8 months) and post-intervention (12 months) and sustained effects (16 months). Participants will be analyzed as randomized regardless of withdrawal from the intervention (i.e., intention-to-treat principals) and missing data will be imputed.
Interventions
BEHAVIORALMOSAIC
All MOSAIC PWD participants receive monthly phone coaching following a semi-structured protocol plus daily automated text message support. MOSAIC uses the mobile phone-delivered structure and functionality developed for FAMS (NCT04347291). Tailoring rules novel to MOSAIC determine phone coaching protocol content, text message content, and the involvement of a SP. Semi-structured protocols used in prior studies (and in the case of NCT04334109 adapted for mobile phone-delivery) are employed. Per tailoring rules, enrolled SPs may be invited to participate in monthly coaching calls with the PWD and/or receive text messages about supporting the PWD. The study will not assess outcomes or effects among SPs.
BEHAVIORALPrint Materials
Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters
Sponsors
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The labs analyzing A1c results (primary outcome, hemoglobin A1c) are masked to the study description or participants' assigned condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
PERSONS WITH DIABETES: * 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 diabetes medication * Owns a mobile phone SUPPORT PERSONS: * Speaks and reads in English * 18 years or older * Owns a mobile phone
Exclusion criteria
PERSONS WITH DIABETES: * Unable to communicate by phone * Currently pregnant * 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 * Demonstrated an inability to receive and respond to a text * Does not take medication on his/her own/medication administered by someone else SUPPORT PERSONS: * Demonstrated inability to receive \& respond to a text * Unable to communicate by phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c During Intervention Period | Baseline and 4, 8, and 12 months post-baseline | Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management |
| Change in Hemoglobin A1c Sustained Post-intervention Effects | Baseline and 16 months post-baseline | Hemoglobin A1c assessed by mail-in A1c kits and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic management |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes Distress During Intervention Period | Baseline and 4, 8, and 12 months post-baseline | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse) |
| Change in Diabetes Distress Sustained Post-intervention Effect | Baseline and 16 months post-baseline | Assessed by the Problem Areas in Diabetes (PAID-5) with scores ranging 0-100 where higher scores indicate more emotional, psychological and social distress related to diabetes management (worse) |
| Change in Psychosocial Well-being During Intervention Period | Baseline and 4, 8, and 12 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 Sustained Post-intervention Effect | Baseline 16 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) |
Countries
United States
Outcome results
None listed