Veteran Support and Resources for Diabetes

NCT04041375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2024-11-07

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

iNSPiRED

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.

OTHER

Usual Care

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Mark E. Kunik, MD MPH · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-08-09
Completion
2022-08-09

Countries

  • United States

Study Locations

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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 NCT04041375 on ClinicalTrials.gov