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Veteran Support and Resources for Diabetes (iNSPiRED)

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ClinicalTrials.gov Identifier: NCT04041375
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: iNSPiRED Other: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Using Peer Navigators to Increase Access to VA and Community Resources for Veterans With Diabetes-related Distress
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Experimental: iNSPiRED
Peer coaching intervention
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 Name: Veteran Support and Resources for Diabetes

Active Comparator: Usual Care
Directory of resources and encouragement to follow-up with Primary Care Physician
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




Primary Outcome Measures :
  1. Change in Diabetes Distress Screening Scale (DDS17) [ Time Frame: Baseline, 3 months, 6 months ]
    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. Minimum score 17. Maximum score 102. Higher scores indicate worse distress.


Secondary Outcome Measures :
  1. Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA) [ Time Frame: Baseline, 3 months, 6 months ]
    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, diabetes-specific diet, physical activity, blood-glucose testing, foot care, and smoking. Minimum score 0. Maximum score 77. Higher scores indicate better self care.

  2. Change in Patient Health Questionnaire-8 (PHQ-8) [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  3. Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7) [ Time Frame: Baseline, 3 months, 6 months ]
    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.

  4. Change in Use of community resources [ Time Frame: From baseline until first change in care (yes to no or no to yes) assessed through 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


Other Outcome Measures:
  1. Change in PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Patient and Stakeholder Survey [ Time Frame: Baseline and every 6 months assessed up to month 60. ]
    The investigators will measure engagement from the community partner perspective using the PCORI WE-ENACT Patient and Stakeholder Survey. This measure includes items to describe engagement from the stakeholder point of view. Its design allows administration at multiple points to track engagement over time and detect changes in partnership development, communication, trust, and research capacity. One or two key representatives from each community partner agency will participate. Minimum score 0. Maximum score 48. Higher scores indicate greater engagement.

  2. Change in Patient Activation Measure (PAM) [ Time Frame: Baseline, 3 months, 6 months ]
    The Patient Activation Measure (PAM) is designed to measure the extent to which patients endorse subjective ability to self-manage their chronic health conditions. Items assess several aspects of self-management, including knowledge (e.g., "I know what each of my prescribed medications do"), skill (e.g., "I have been able to maintain the lifestyle changes for my health that I have made"), and confidence (e.g., "I am confident I can tell my health care provider concerns I have even when he or she does not ask"). Minimum score 13. Maximum score 52. Higher scores indicate more patient activation.

  3. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: Baseline, 3 months, 6 months ]
    PROMIS measures self-efficacy related to managing daily activities, emotions, and social interactions will be assessed. Items are rated on a 5-point scale corresponding to the respondent's degree of confidence for managing various problems or functions. Minimum score 12. Maximum score 60. Higher scores indicate higher self-efficacy.

  4. Change in PCORI Ways of Engaging-Engagement Activity Tool (WE-ENACT) Researcher Survey [ Time Frame: Baseline and every 6 months assessed up to month 60 ]
    The investigators will measure engagement from the researcher perspective using a modified version of the PCORI WE-ENACT Researcher Survey. Minimum score 0. Maximum score 33. Higher scores indicate more engagement.

  5. Change in Use of VHA resources [ Time Frame: From baseline until first change in care (yes to no or no to yes) assessed through month 6 ]
    The investigators will record the Veteran's self-report of use of VHA resources including mental health care and counseling, DM classes, nutrition services, primary care appointments, and other health-related services. Dichotomous Yes = care in VHA. No= no care in VHA.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041375


Contacts
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Contact: Mark E Kunik, MD MPH (713) 794-8646 kunik.marke@va.gov
Contact: Tracy L Evans, MPH RN (713) 440-4433 tracy.evans1@va.gov

Locations
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United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX Recruiting
Houston, Texas, United States, 77030
Contact: Mark E Kunik, MD MPH    713-794-8646    kunik.marke@va.gov   
Contact: Tracy L Evans, MPH RN    (713) 440-4433    tracy.evans1@va.gov   
Principal Investigator: Mark E. Kunik, MD MPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Mark E. Kunik, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04041375     History of Changes
Other Study ID Numbers: IIR 17-221
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final data sets underlying publications from this research will be made available to the public in electronic form. The investigators will provide a de-identified, quantitative dataset compliant with VA data security policy to the public upon request to the principal investigator. Qualitative data cannot be shared because it has identifiable, sensitive information that cannot be practicably de-identified. Notices advising the public of the availability of the dataset will appear in all publications authored by our research team.
Time Frame: After the data is analyzed and published

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
peer support
mental health
diabetes self-management
community-based participatory research
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases