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FAMS Mobile Health Intervention for Diabetes Self-care Support

NCT02481596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 512

Last updated 2019-11-27

Study results available
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Summary

This study evaluates a family-focused mobile phone-delivered intervention, called FAMS (Family-focused Add-on for Motivating Self-care), in supporting adults with type 2 diabetes in their self-management relative to a control group. The goal of this study is to ascertain if family-focused content delivered to the patient can improve the patients' family support for diabetes self-care, self-efficacy, and adherence to diet and exercise recommendations.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

REACH + FAMS

The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.

BEHAVIORAL

REACH

The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).

BEHAVIORAL

Helpline & A1c results

Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Lindsay S Mayberry, MS, PhD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-23
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481596 on ClinicalTrials.gov