MObile Support Adapted to Individual Contexts

NCT06828549 | Enrolling By Invitation DMC

• 2 other identifiers: 2420661R01DK140190-01
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 2

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. 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. 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.

Conditions

Type 2 Diabetes

Keywords

family support; social support; text message; mobile health; hemoglobin A1c

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c During Intervention Period

  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

  Baseline and 4, 8, and 12 months post-baseline

• Change in Hemoglobin A1c Sustained Post-intervention Effects

  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

  Baseline and 16 months post-baseline

Secondary Outcomes (4)

• Change in Diabetes Distress During Intervention Period

  Baseline and 4, 8, and 12 months post-baseline

• Change in Diabetes Distress Sustained Post-intervention Effect

  Baseline and 16 months post-baseline

• Change in Psychosocial Well-being During Intervention Period

  Baseline and 4, 8, and 12 months post-baseline

• Change in Psychosocial Well-being Sustained Post-intervention Effect

  Baseline 16 months post-baseline

Other Outcomes (8)

• Change in Diabetes Self-efficacy (Outcome & Mediator)

  Baseline and 4, 8, 12, and 16 months post-baseline

• Change in Diabetes Self-care Quality (Outcome & Mediator)

  Baseline and 4, 8, 12, and 16 months post-baseline

• Change in Dietary Behavior (Outcome & Mediator)

  Baseline and 4, 8, 12, and 16 months post-baseline

Study Arms (2)

MOSAIC

EXPERIMENTAL

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.

Behavioral: MOSAIC; Behavioral: Print Materials

Print Materials

PLACEBO COMPARATOR

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.

Behavioral: Print Materials

Interventions

MOSAIC BEHAVIORAL

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.

Also known as: Family/friend Activation to Motivate Self-Care (FAMS; NCT04347291), Family Diabetes Self-Management Education and Support (NCT04334109), Standard Diabetes Self-Management Education and Support (NCT04334109), Diabetes Distress Reduction

MOSAIC

Print Materials BEHAVIORAL

Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters

MOSAIC; Print Materials

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PERSONS WITH DIABETES:
• Speaks and reads in English
• 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
• years or older
• Owns a mobile phone

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Alabama at Birmingham: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Mosaicism; Palliative Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chromosome Aberrations; Mutation; Genetic Variation; Genetic Phenomena; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The labs analyzing A1c results (primary outcome, hemoglobin A1c) are masked to the study description or participants' assigned condition.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 21, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After study results are posted on clinical trials (required to occur within 1 year of final data collection), scientific data will be submitted to the Open Science Framework (OSF). Under the current repository policies, data will be preserved and available for the wider research community in perpetuity.
• Access Criteria: Survey, clinical, and laboratory data and associated study documentation (survey codebook; analytic code used in survey and clinical data analyses; standard citation and unique identifier to facilitate attribution of data use) will be shared and made publicly available through OSF as open access. Survey, clinical, and laboratory data will be made available in csv and text format and will not require the use of specialized tools to be accessed or manipulated. All shared data and documentation will be findable and identifiable using the standard data indexing tools in Open Science Framework.

Locations

US (2)