CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 638 enrolled
Drug / intervention
FAMS 2.0 +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04347291
NCT04347291N/ACompleted

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

Vanderbilt University Medical Center·interventional·Posted Apr 15, 2020·Updated Jan 17, 2024

In Brief

A clinical study evaluating FAMS 2.0 and Print Materials for Type 2 Diabetes. Completed, enrolled 638 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 15, 2020
Enrollment StartApr 28, 2020
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.2 years ago

Interventions

FAMS 2.0behavioral

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.

Print Materialsbehavioral

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