VetASSIST: Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Not yet recruiting
CT.gov ID
NCT05560451
Collaborator
(none)
294
1
2
42
7

Study Details

Study Description

Brief Summary

The VetASSIST study is a randomized clinical trial testing whether receiving virtual health coaching from Veteran peers improves the physical and mental health-related quality of life of Veterans with multiple chronic health conditions and complex healthcare needs. VetASSIST will test the efficacy of an intervention that matches Veteran patients with multimorbidty with Veteran health coaches who will provide education, resources, guidance and support to help them manage their physical and mental health over the course of a year.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Peer health coach intervention
N/A

Detailed Description

The study objective is to evaluate the effectiveness of a virtual, Veteran peer-led self-management support program (VetASSIST) to improve health related quality of life (HRQoL) for Veterans with multimorbidity compared to usual care. The investigators will conduct a type 1 hybrid effectiveness-implementation randomized controlled trial of the intervention among VA Puget Sound patients with multimorbidity. Trained peer health coaches will virtually meet one-on-one with patients to assist in daily self-management by providing information; identifying patients' values and preferences; helping them set goals in alignment with their values and preferences and problem-solve barriers to those goals; modeling skills for effective management; providing social support; linking them to clinical care and community resources; and addressing self-management barriers. Veterans with multimorbidity will be randomized to receive the peer health coaching intervention or usual care. Outcomes will be assessed remotely at baseline and 12 months.

Specific aims are: 1) Test the effect of VetASSIST, compared to usual care, on the primary outcome of baseline to 12-month change in physical HRQoL, and secondary outcomes of mental HRQoL and health care utilization; 2a) Describe differences between VetASSIST and usual care on baseline to 12-month changes in intermediate outcomes reflecting the functions of peer support and intervention targets (self-efficacy, patient activation, health behaviors, social support, perceived access to care, patient-provider communication, and shared decision-making); 2b) Examine whether intermediate outcomes mediate intervention-associated differences in HRQoL; 3) Evaluate feasibility of translating VetASSIST into practice, including evaluation of per patient intervention costs and barriers and facilitators to implementation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Hybrid type 1 trial with 294 Veterans with multimorbidity. Participants will be randomized to one of two groups -- the control or intervention group -- in parallel for the duration of the study.Hybrid type 1 trial with 294 Veterans with multimorbidity. Participants will be randomized to one of two groups -- the control or intervention group -- in parallel for the duration of the study.
Masking:
None (Open Label)
Masking Description:
Concealment will be used to prevent the study staff from obtaining information on the sequence of assignment. Because of the nature of the intervention, we are unable to blind participants and staff to treatment assignment.
Primary Purpose:
Health Services Research
Official Title:
Telehealth-delivered Peer Support to Improve Quality of Life Among Veterans With Multimorbidity
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 31, 2026
Anticipated Study Completion Date :
Sep 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Peer health coach intervention

Participants will receive 20 virtual visits with a trained Veteran peer health coach over 12 months. Coaches will provide participants with brief health education, assist with goal setting and problem solving, enhance social support, and link participants to VA and community resources.

Behavioral: Peer health coach intervention
Eligible participants will be randomly assigned to receive a telehealth delivered peer health coach intervention to promote health outcomes and behavior change among Veterans with multimorbidty.
Other Names:
  • VetASSIST
  • No Intervention: Control group/no intervention

    Participants will continue to receive their regular, usual primary care.

    Outcome Measures

    Primary Outcome Measures

    1. Change in physical health related quality of life (HRQoL) [Baseline to 12-months]

      12 Item Short Form Health Survey (SF-12) Physical Component Summary: Summary scores for general health, physical functioning, role-physical, and bodily pain. Scaling scores will be assessed using published standardized scoring system procedures for the SF-12 found at: www.researchgate.net/publication/242636950_SF-12_How_to_Score_the_SF-12_Physical_and_Mental_Health_Summary_Scales

    Secondary Outcome Measures

    1. Change in mental health quality of life (HRQoL) [Baseline to 12-months]

      12 Item Short Form Health Survey (SF-12) Mental Component Summary: Summary scores for vitality, mental health, social functioning, and role-emotional. Scaling scores will be assessed using published standardized scoring system procedures for the SF-12 found at: www.researchgate.net/publication/242636950_SF-12_How_to_Score_the_SF-12_Physical_and_Mental_Health_Summary_Scales

    2. Health care utilization [Baseline to 12-months]

      Measured by VA clinical and administrative data and self-report responses (non-VA care), including primary care, specialty care, inpatient admissions, emergency department visits. A higher number of visits indicates greater utilization.

    Other Outcome Measures

    1. Self-efficacy [Baseline to 12-months]

      Measured by the Self-Efficacy to Manage Chronic Disease Scale to assess perceived capability to perform actions required to manage chronic diseases. Confidence is measured on a 10-point scale ranging from (1) not at all confident to (10) totally confident. A higher score indicates higher self-efficacy/confidence.

    2. Patient activation [Baseline to 12-months]

      Measured by the Consumer Health Activation Index (CHAI) to assess ability to take preventive actions, manage symptoms, find and use medical care, and work with health care providers. Responses are measured as low activation vs. not low activation on a 4-point scale ranging from almost always true (1) to almost never true (4). A higher score indicates lower activation.

    3. Social support [Baseline to 12-months]

      Medical Outcomes Study (MOS) 8-Item Social Support Survey Instrument will measure emotional, instrumental, informational, and appraisal of social support. Social Support is scored using a 5-point response scale ranging from none of the time (1) to all of the time (5). A higher score for an individual scale or overall support index indicates greater support.

    4. Loneliness [Baseline to 12-months]

      Three-Item UCLA Loneliness Scale will measure subjective feelings of being lonely or isolated. Responses are measured using a 3-point response scale ranging from hardly ever (1) to often (3). A higher score indicates greater loneliness.

    5. Access to care [Baseline to 12-months]

      Consumer Assessment of Healthcare Providers and Systems (CAHPS) - access to care- will measure getting timely appointments, care, and information. Responses are measured using a 4-point response scale ranging from never (1) to always (4). A higher score indicates increased access to care.

    6. Patient-provider communication [Baseline to 12-months]

      Consumer Assessment of Healthcare Providers and Systems (CAHPS) - patient-provider communication- will measure communication with physician and health care team. Responses are measured using a 4-point response scale ranging from never (1) to always (4). A higher score indicates greater communication.

    7. Shared decision-making [Baseline to 12-months]

      CollaboRATE will measure explanation of health issues; elicitation and integration of patient preferences. Responses are measured using a 10-point response scale ranging from no effort was made (0) to every effort was made (9). A higher score indicates greater shared decision making.

    8. Diet quality [Baseline to 12-months]

      Starting the Conversation brief dietary assessment and intervention scale will measure diet quality. Responses are measured using a 3-point response scale. Items have a score range of 0, 1, 2. The total ranges from scores of 0 to 16. A higher score indicates a less healthful diet.

    9. Medication adherence [Baseline to 12-months]

      Voils Domains of Subjective Extent of Nonadherence (DOSE-Nonadherence) Reasons for Nonadherence measure will identify possible reasons for nonadherence to prescribed treatment. Medication adherence is scored using a 5-point response scale ranging from none of the time (1) to all of the time (5). Higher scores indicate greater nonadherence.

    10. Tobacco use [Baseline to 12-months]

      Behavioral Risk Factor Surveillance System (BRFSS) Questionnaire will measure tobacco use. Questions will assess current tobacco use and frequency of use. Current tobacco use includes individuals who report having smoked at least 100 cigarettes in their entire life and who report smoking cigarettes now (every day or some days).

    11. Alcohol use [Baseline to 12-months]

      AUDIT Alcohol Consumption questionnaire (AUDIT-C) will measure alcohol use. A total of 5+ indicates increased or higher risk drinking. An overall total score of 5 or above is AUDIT-C positive.

    12. Sleep impairment/disturbance [Baseline to 12-months]

      PROMIS Sleep Related Impairment and Sleep Disturbance survey will measure sleep disturbance related impairment. Responses are measured on a 5-point scale ranging from not at all (1) to very much (5). A higher score indicates greater sleep disturbance.

    13. Physical activity [Baseline to 12-months]

      International Physical Activity Questionnaire (IPAQ) Short form assessment will measure physical activity. We will examine total physical activity in minutes per week, totaling all time from walking, moderate, and vigorous activity in the past 7 days. We will also examine physical activity dichotomously, identifying those meeting recommendations of at least 150 minutes total physical activity per week. We will use standard data cleaning procedures outlined by IPAQ developers, available at www.ipaq.ki.se.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Veteran VA Puget Sound patient with >=1 primary care visit within last year

    • Complex multimorbidity (>=3 chronic conditions in >=3 body systems based on AHRQ Chronic Condition Index)

    • Meets >=2 criterion from NICE multimorbidity guidelines:

      1. diagnosis of a mental and physical health condition,
      1. frailty based on JEN Frailty Index, confirmed with self-reported PRISMA-7 score,
      1. one or more visits to the VA emergency department within the past 12 months,
      1. 10 or more regularly prescribed medications,
      1. difficulties managing treatment defined by a score of at least 22 on the self-reported Multimorbidity Treatment Burden Questionnaire Valid e-mail address
    • Reliable access to the Internet

    • Access to a device (personal/VA supplied) compatible with the VA video conferencing platform

    • Agree to participate in the health coaching sessions and surveys if assigned to intervention group

    Exclusion Criteria:
    • Not fluent in English, severe hearing loss, no phone access

    • Dementia or cognitive impairment (diagnosis or six-item cognitive screener score >=2)

    --Pregnant or planning to become pregnant in the next 6 months

    • End stage renal disease and on dialysis

    • Receipt of palliative or hospice care

    • Enrollment in VA Home Based Primary Care

    • Living in a care facility (nursing home or assisted living)

    • Behavior flags in the VA electronic health record

    • Active treatment for non-skin cancer diagnosis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 VA Puget Sound Health Care System Seattle Division, Seattle, WA Seattle Washington United States 98108

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Kristen E. Gray, PhD MS BS, VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT05560451
    Other Study ID Numbers:
    • IIR 21-100
    First Posted:
    Sep 29, 2022
    Last Update Posted:
    Oct 3, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Oct 3, 2022