Veteran Support and Resources for Diabetes

NCT04041375 | Completed Results

• 1 other identifier: IIR 17-221
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

peer support; mental health; diabetes self-management; community-based participatory research

Outcome Measures

Primary Outcomes (1)

• Change in Diabetes Distress Screening Scale (DDS17)

  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.

  Baseline, Month 3, Month 6

Secondary Outcomes (5)

• Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)

  Baseline, Month 3, Month 6

• Change in Summary of Diabetes Self-Care Activities Assessment (SDSCA)--Number of Participants Who Smoked

  Baseline, Month 3, Month 6

• Change in Patient Health Questionnaire-8 (PHQ-8)

  Baseline, Month 3, Month 6

• Change in Generalized Anxiety Disorder-7 Questionnaire (GAD-7)

  Baseline, Month 3, Month 6

• Change in Use of Community Resources (no to Yes)

  Baseline, Month 6

Other Outcomes (7)

• Change in Use of VHA Resources (no to Yes)

  Baseline, Month 6

• Change in Patient Activation Measure (PAM)

  Baseline, Month 3, Month 6

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS)--PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions 4a

  Baseline, Month 3, Month 6

Study Arms (2)

iNSPiRED

EXPERIMENTAL

Peer coaching intervention

Behavioral: iNSPiRED

Usual Care

ACTIVE COMPARATOR

Directory of resources and encouragement to follow-up with Primary Care Physician

Other: Usual Care

Interventions

iNSPiRED BEHAVIORAL

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.

Also known as: Veteran Support and Resources for Diabetes

iNSPiRED

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran
• Diagnosis of type 2 DM, per self-report
• Moderate diabetes-related distress (Diabetes Distress Scale \[DDS2\] mean score of 3 or greater)

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

Related Publications (6)

• 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.

  PMID: 37674395 BACKGROUND

• 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.

  PMID: 36828990 BACKGROUND

• 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.

  PMID: 36253766 BACKGROUND

• 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.

  PMID: 36096091 BACKGROUND

• 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.

  PMID: 36003211 BACKGROUND

• 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.

  PMID: 35853418 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Psychological Well-Being

Interventions

Inhalation; Health Resources

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Connecting participants to medical care and resources for diabetes and mental health self-management was a primary component of the peer coaching intervention. The COVID-19 pandemic reduced the availability of these resources. The impact of reduced availability of resources on the study results is unknown.

Results Point of Contact

• Title: Dr. Natalie E. Hundt
• Organization: Michael E. DeBakey VAMC

natalie.hundt@va.gov

713-791-1414

Study Officials

• Mark E. Kunik, MD MPH

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 1, 2019
• Study Start: October 1, 2019
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: November 7, 2024
• Results First Posted: July 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the data is analyzed and published

Locations

US (1)