N/A
N=218
Veteran Support and Resources for Diabetes
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04041375 ↗Enrolled (actual)
218
Serious AEs
10.5%
Results posted
Jul 2024
Primary outcome: Primary: Change in Diabetes Distress Screening Scale (DDS17) — 3.0; 3.1; 3.3; 3.3 score on a scale — p=0.42
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- iNSPiRED (Behavioral); Usual Care (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Diabetes Distress Screening Scale (DDS17) |
3.0; 3.1; 3.3; 3.3; 2.7; 2.6 | 0.42 |
| SECONDARY Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) |
3.3; 3.3; 2.8; 2.8; 3.7; 3.1 | 0.03 sig |
| SECONDARY Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked |
23; 23; 20; 24; 20; 23 | — |
| SECONDARY Change in Patient Health Questionnaire-8 (PHQ-8) |
11.4; 11.8; 9.3; 9.7; 9.6; 9.6 | 0.93 |
| SECONDARY Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) |
10.9; 11.4; 9.3; 9.3; 9.6; 9.2 | 0.66 |
| SECONDARY Change in Use of Community Resources (no to Yes) |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Veteran
- Diagnosis of type 2 DM, per self-report
- Moderate diabetes-related distress (Diabetes Distress Scale [DDS2] mean score of 3 or greater)
Exclusion Criteria
- Lack of reliable access to a telephone
- Cognitive, sensory, or other impairment that prevents use of a telephone
- Current participation in another diabetes-related counseling or self-management program
Data sourced from ClinicalTrials.gov (NCT04041375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.