MObile Support Adapted to Individual Contexts (MOSAIC)

Vanderbilt University Medical Center

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Behavioral: Print Materials; Behavioral: MOSAIC

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06828549

1R01DK140190-01 (U.S. NIH Grant/Contract)

242066

Details and patient eligibility

About

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.

Full 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.

Enrollment: 547 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 daily 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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547 participants in 2 patient groups, including a placebo group

MOSAIC

Experimental group

Description:

PWD participants will receive MOSAIC components (monthly phone coaching and text message support for goals and medication adherence) for 12 months. PWD participants will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. All SP participants invited by PWD participants assigned to MOSAIC will receive high-quality print materials upon enrollment and quarterly newsletters on healthy living with diabetes. SPs may participate in monthly phone coaching and/or receive text message support tailored to the goal set by the linked PWD.

Treatment:

Behavioral: MOSAIC

Behavioral: Print Materials

Print Materials

Placebo Comparator group

Description:

PWD 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 health living with diabetes.

Treatment:

Behavioral: Print Materials