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Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes

NCT04347291 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2024-01-17

Study results available
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Summary

This study evaluates a mobile phone-delivered intervention (FAMS 2.0; Family/friend Activation to Motivate Self-care) designed to help adults with type 2 diabetes set and achieve self-care goals and improve the quality of family/friend support for their goals. The investigators hypothesize that FAMS 2.0 will improve glycemic control and reduce diabetes distress among patients and reduce support burden and diabetes distress in enrolled support persons. The investigators hypothesize the mechanisms by which FAMS 2.0 will affect these outcomes for the patient include (a) increased helpful and reduced harmful family/friend involvement, (b) increased self-care (i.e., diet, physical activity, medication adherence), and (c) increased diabetes self-efficacy.

Conditions

Interventions

BEHAVIORAL

FAMS 2.0

FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.

BEHAVIORAL

Print Materials

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

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-28
Primary Completion
2023-02-17
Completion
2023-02-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04347291 on ClinicalTrials.gov