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NCT04347291 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
638
Enrollment target

NCT04347291: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT04347291 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 638 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04347291, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
638 participants
Enrollment target

Study 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.

Primary Outcome

Hemoglobin A1c assessed by mail-in A1c kits from CoreMedica and/or taken from electronic health record (venipuncture or point-of-care) where higher values indicate worse glycemic control

Interventions

  • BEHAVIORAL Print Materials
  • BEHAVIORAL FAMS 2.0

Trial Details

FieldValue
Enrollment Target 638 participants
Start Date 2020-04-28
Est. Completion 2023-02-17
Phase NA

What the finished NCT04347291 record still lists

NCT04347291 is an interventional study that assigns participants to a tested intervention. The registered 638 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower).

The record links to 0 conditions, and to 2 interventions - of which Print Materials is the first listed.

NCT04347291 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04347291 about?

NCT04347291 is a clinical study titled "Mobile Phone Support for Adults and Support Persons to Live Well With Diabetes". 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...

What is the current status of trial NCT04347291?

This trial is currently completed. It is a NA study. The enrollment target is 638 participants. The study started on 2020-04-28. Estimated completion is 2023-02-17.

What interventions are being tested in trial NCT04347291?

The interventions under investigation include: Print Materials (BEHAVIORAL), FAMS 2.0 (BEHAVIORAL).

Who is sponsoring clinical trial NCT04347291?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04347291's enrollment target sits among peer trials

638 157th of 2000 higher than 1,844 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04347291, the US trial registry maintained by the National Library of Medicine. NCT04347291 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.