MObile Support Adapted to Individual Contexts

Official title

MObile Support Adapted to Individual Contexts (MOSAIC Study)

Overview

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

• Behavioral MOSAIC
  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 t
• Behavioral Print Materials
  Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters

Primary outcome measures

• Change in Hemoglobin A1c During Intervention Period [Time frame: Baseline and 4, 8, and 12 months post-baseline]
• Change in Hemoglobin A1c Sustained Post-intervention Effects [Time frame: Baseline and 16 months post-baseline]

Secondary outcome measures (4)

• Change in Diabetes Distress During Intervention Period [Time frame: Baseline and 4, 8, and 12 months post-baseline]
• Change in Diabetes Distress Sustained Post-intervention Effect [Time frame: Baseline and 16 months post-baseline]
• Change in Psychosocial Well-being During Intervention Period [Time frame: Baseline and 4, 8, and 12 months post-baseline]
• Change in Psychosocial Well-being Sustained Post-intervention Effect [Time frame: Baseline 16 months post-baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• University of Alabama at Birmingham — Birmingham
• Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT06828549 · 242066 · 1R01DK140190-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗