CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 219 enrolled
Drug / intervention
iNSPiRED +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/NCT04041375
NCT04041375N/ACompleted

Using Peer Navigators to Increase Access to VA and Community Resources for Veterans With Diabetes-related Distress

VA Office of Research and Development·interventional·Posted Aug 1, 2019·Updated Nov 7, 2024

In Brief

A clinical study evaluating iNSPiRED and Usual Care for Diabetes. Completed, enrolled 219 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 1, 2019
Enrollment StartOct 1, 2019
Primary CompletionAug 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 6.9 years ago

Interventions

iNSPiREDbehavioral

The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.

Usual Careother

Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations