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NCT04041375 · ClinicalTrials.gov registry record · NA

Veteran Support and Resources for Diabetes

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
219
Enrollment target

NCT04041375: Completed NA study, sponsored by VA Office of Research and Development.

NCT04041375 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 219 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT04041375, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
219 participants
Enrollment target

Study Summary

Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs that help with medical problems and stress by teaching ways to better manage diabetes and stress may improve the lives of those with diabetes. Many excellent programs are available in the VA and in the community that help persons with diabetes better manage their medical problems and stress, but often times Veterans have trouble finding these programs. The purpose of the study is to see if a telephone-based coaching program improves the physical and emotional health of Veterans with diabetes more than use of a directory of community and VA resources and no coaching. The Veterans who receive the directory of community and VA resources will be given this at the beginning of the study and will access resources as they see fit. Those in the coaching program will be coached by a Veteran with knowledge of diabetes, mental health and community resources who will help them connect to care in the VA and/or community depending on their preference. Examples of resources available in the VA and community include mental health care and programs to help with diet, exercise and learning about how to better manage diabetes. Veterans who are interested in participating and pass screening will be enrolled in the study for about 6 months. Each enrolled Veteran will have a 50% chance of being enrolled in the coaching group and a 50% chance of being enrolled in the directory group (like the flip of a coin). Both groups will be asked to complete several questionnaires about their health and well-being by telephone. This will occur at the beginning of the study and three and six months later. The questionnaires will take about an hour to complete each time.

Primary Outcome

The content of the DDS17 was developed with the input of people with DM and clinicians with expertise in DM. Items are grouped into 4 subscales: Emotional Burden ("Feeling angry, scared and/or depressed when I think about living with diabetes"), Physician-related Distress ("Feeling that my doctor doesn't take my concerns seriously enough"), Regimen-related Distress ("Not feeling confident in my day-to-day ability to manage diabetes"), and Interpersonal Distress ("Feeling that friends or family d

Interventions

  • OTHER Usual Care
  • BEHAVIORAL iNSPiRED

Trial Details

FieldValue
Enrollment Target 219 participants
Start Date 2019-10-01
Est. Completion 2022-08-09
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT04041375 record still lists

NCT04041375 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (84% lower).

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

NCT04041375 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04041375 about?

NCT04041375 is a clinical study titled "Veteran Support and Resources for Diabetes". Patients with diabetes are often challenged by the routine of managing their diabetes, and may experience both stress and medical problems. Diabetes-related medical problems and stress often happen together and affect peoples' ability to live a full, happy and healthy life. Because of this, programs...

What is the current status of trial NCT04041375?

This trial is currently completed. It is a NA study. The enrollment target is 219 participants. The study started on 2019-10-01. Estimated completion is 2022-08-09.

What interventions are being tested in trial NCT04041375?

The interventions under investigation include: Usual Care (OTHER), iNSPiRED (BEHAVIORAL).

Who is sponsoring clinical trial NCT04041375?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04041375's enrollment target sits among peer trials

219 485th of 2000 higher than 1,516 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 NCT04041375, the US trial registry maintained by the National Library of Medicine. NCT04041375 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.