Clinical trial NCT04041375: Veteran Support and Resources for Diabetes
Official title: Using Peer Navigators to Increase Access to VA and Community Resources for Veterans With Diabetes-related Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: peer support
mental health
diabetes self-management
community-based participatory research
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-08-01
Enrollment: 219
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind, parallel group, randomized trial of a 3-month peer-navigation intervention for Veterans with DM and elevated levels of diabetes-related distress. Participants will be assigned at random (see below) to the intervention (peer navigation with follow-up) or usual care (print materials and encouragement to continue follow-up with health care providers). Assessment of primary, secondary and intermediate end points will occur pre-intervention at baseline and post-intervention at 3 and 6 months.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Diabetes Distress Screening Scale (DDS17)
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked
timeFrame: Baseline, Month 3, Month 6
measure: Change in Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Use of Community Resources (no to Yes)
timeFrame: Baseline, Month 6
Other outcomes:
measure: Change in Use of VHA Resources (no to Yes)
timeFrame: Baseline, Month 6
measure: Change in Patient Activation Measure (PAM)
timeFrame: Baseline, Month 3, Month 6
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a
timeFrame: Baseline, Month 3, Month 6
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Daily Activities 4a
timeFrame: Baseline, Month 3, Month 6
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Social Interactions 4a
timeFrame: Baseline, Month 3, Month 6
measure: Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey
timeFrame: Baseline and every 12 months assessed up to month 48
measure: Number of Participants Who Completed the PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey
timeFrame: Baseline and every 12 months assessed up to month 48.
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Mark E. Kunik, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cully JA, Hundt NE, Fletcher T, Sansgiry S, Zeno D, Kauth MR, Kunik ME, Sorocco K. Brief Cognitive-Behavioral Therapy for Depression in Community Clinics: A Hybrid Effectiveness-Implementation Trial. Psychiatr Serv. 2024 Mar 1;75(3):237-245. doi: 10.1176/appi.ps.20220582. Epub 2023 Sep 7.
citation: Dawson DB, Mohankumar R, Puran D, Nevedal A, Maguen S, Timko C, Kunik ME, Breland JY. Weight Management Treatment Representations: A Novel Use of the Common Sense Model. J Clin Psychol Med Settings. 2023 Dec;30(4):884-892. doi: 10.1007/s10880-023-09946-4. Epub 2023 Feb 24.
citation: Chen GJ, Kunik ME, Marti CN, Choi NG. Cost-effectiveness of Tele-delivered behavioral activation by Lay counselors for homebound older adults with depression. BMC Psychiatry. 2022 Oct 17;22(1):648. doi: 10.1186/s12888-022-04272-9.
citation: Mishra RK, Park C, Momin AS, Rafaei NE, Kunik M, York MK, Najafi B. Care4AD: A Technology-Driven Platform for Care Coordination and Management: Acceptability Study in Dementia. Gerontology. 2023;69(2):227-238. doi: 10.1159/000526219. Epub 2022 Sep 12.
citation: Boykin DM, Wray LO, Funderburk JS, Holliday S, Kunik ME, Kauth MR, Fletcher TL, Mignogna J, Roberson RB 3rd, Cully JA. Leveraging the ExpandNet framework and operational partnerships to scale-up brief Cognitive Behavioral Therapy in VA primary care clinics. J Clin Transl Sci. 2022 Jul 20;6(1):e95. doi: 10.1017/cts.2022.430. eCollection 2022.
citation: Choi NG, Choi BY, Marti CN, Kunik ME. Depression/anxiety symptoms and self-reported difficulty managing medication regimen among community-dwelling older adults. Gen Hosp Psychiatry. 2022 Sep-Oct;78:50-57. doi: 10.1016/j.genhosppsych.2022.07.005. Epub 2022 Jul 15.