Veteran Support and Resources for Diabetes

Not Applicable

Completed

Conditions: Diabetes

Interventions: Behavioral: iNSPiRED
Other: Usual Care

Registration Number: NCT04041375

Lead Sponsor: VA Office of Research and Development

Brief 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.

Detailed Description: Diabetes-related distress, the negative emotional impact of living with diabetes (DM), is a powerful predictor of psychosocial functioning, treatment adherence, and glycemic control. Practice guidelines and consensus statements call for innovative approaches to address DM-related distress. Despite availability of self-management and psychosocial interventions to reduce DM related distress, these interventions are underutilized due to constraints in time, finances, motivation, and resource-awareness. Interventions that leverage traditional medical care and community-based health promotion programs (e.g., DM self-management education (DSME) programs) may enhance the ability of Veterans with DM to engage with a broad and accessible range of resources. Ensuring that Veterans with DM receive adequate self-care support requires interventions that (1) attend to both medical care and diabetes-related distress and (2) improve Veterans' access and engagement with DSME and traditional medical/mental care. Integrating VA and community health services and DSME resources is innovative and affords great opportunities to enhance Veteran outcomes and build VA community partnerships. Engagement of Veterans and community organizations in developing and delivering care responds to the 2016 HSR\&D high-priority domain of Health Care Systems Change and aligns with the 2017 VA Under Secretary's priorities of Greater Choice (offering community and VA resources), Efficiency (community and VA coordination), and Timeliness (telephone delivery).

This community-VA partnership and three-month Veteran peer coaching intervention (iNSPiRED) aims to enhance psychological well-being and diabetes self-management behavior in Veterans with DM by facilitating access to and use of healthcare and health promotion resources. The intervention focuses on reducing cognitive and practical barriers to use of services by engaging Veteran peers as coaches and navigators, and by encouraging engagement in health promotion and healthcare services in the VA and the greater community. A secondary goal, integral to the main goal, is to strengthen and integrate VHA partnerships with community-based organizations and Veteran Support Organizations (VSO's).

This is a single-blind, parallel group randomized trial of a 3-month peer navigation intervention for Veterans with DM and elevated levels of DM-related distress. The investigators will recruit Veterans with DM-related distress through existing help-seeking channels within and outside of the VA in partnership with community agencies, VSO's, and the Houston VAMC. Eligible Veterans will be assigned at random to the iNSPiRED intervention (peer navigation and coaching) versus usual care (written resource materials and encouragement to continue follow-up with healthcare providers). Consistent with the focus on the overall emotional impact of DM, the PRIMARY OUTCOME is DM-related distress (DM Distress Scale). In previous studies the DDS has shown strong relationships with psychological symptoms, self-management behaviors, and objective measures of glycemic control. SECONDARY OUTCOMES include anxiety symptoms (Generalized Anxiety Disorder Scale), depression symptoms (Patient Health Questionnaire-8), DM self-management behaviors (DM Self-Management Scale), and self-reported use and new use of VA or community resources. In addition to participant-level outcomes, the investigators will also assess STAKEHOLDER OUTCOMES through a mixed methods process evaluation. The objective will be to measure the impact of stakeholder engagement activities on development and sustainability of VA-community partnerships, trust and communication, and capacity building. Assessment of primary and secondary endpoints will occur at baseline, post-intervention, and at 6 months.

If this project meets intended goals, the investigators will partner with VHA Office of Community Engagement and VHA Specialty Care to implement the intervention for DM and other chronic diseases.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 219

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iNSPiRED	iNSPiRED	Peer coaching intervention
Usual Care	Usual Care	Directory of resources and encouragement to follow-up with Primary Care Physician

Primary Outcome Measures

Name	Time	Method
Change in Diabetes Distress Screening Scale (DDS17)	Baseline, Month 3, Month 6	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 don't give me the emotional support that I would like"). Items are rated on a Likert scale indicating the extent to which each factor is distressing, from 1 (no problem) to 6 (a serious problem). The instrument is scored by computing the average value across items to obtain a total score and four subscale scores. Minimum score 1. Maximum score 6. Higher scores indicate worse distress.

Secondary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-8 (PHQ-8)	Baseline, Month 3, Month 6	The PHQ-8 is an eight-item questionnaire that assesses the frequency of depression and mood-related symptoms (e.g., "Feeling down, depressed, or hopeless," "Trouble falling or staying asleep, or sleeping too much") over the past 2 weeks. Minimum score 0. Maximum score 24. Higher scores indicate worse depression.
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)	Baseline, Month 3, Month 6	The SDSCA measure is a brief self-report questionnaire of diabetes self-management. It assesses the number of days per week in which respondents engage in diabetes health-related behaviors in the areas of general diet, fruits and vegetable intake, fat intake, physical activity, blood-glucose testing, and foot care. and smoking. Minimum score 0. Maximum score 7 (for each area). Higher scores indicate better self care. Smoking in the last week is also assessed as a binary variable (see separate entry).
Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked	Baseline, Month 3, Month 6	The SDSCA measure is a brief self-report questionnaire of diabetes self-management. Any smoking in the last week is assessed as a binary variable. Minimum score 0 (did not smoke). Maximum score 1 (smoked). See separate entry for SDSCA items that measure the number of days per week an activity is performed. Reported counts reflect number of participants who indicated smoking in the last week.
Change in Use of Community Resources (no to Yes)	Baseline, Month 6	The investigators will record the Veteran's self-report of any use of community-based resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous. Yes = care in the community. No= no care in the community
Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)	Baseline, Month 3, Month 6	The GAD-7 is a 7-item questionnaire developed as a companion to the PHQ-9 to screen for generalized anxiety disorder and other common anxiety disorders. Items assess the frequency of anxiety symptoms (e.g., "Worrying too much about different things," "Feeling afraid as if something awful might happen") over the past 2 weeks. Minimum score 0. Maximum score 21. Higher scores indicate worse anxiety.