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

NCT ID: NCT05560451

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multimorbidity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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. Staff who complete outcomes assessment are masked to study assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Peer health coach intervention

Intervention Type BEHAVIORAL

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.

Control group/no intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VetASSIST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Veteran patient receiving primary care from VA Puget Sound
* Complex multimorbidity (\>=3 chronic conditions in \>=3 body systems based on AHRQ Chronic Condition Index)
* Meets \>=2 criterion from NICE multimorbidity guidelines: 1) have a chronic physical and mental health condition (via ICD-10 codes in CDW and the CCI); 2) frailty (determined by the JEN Frailty Index available in VA data, confirmed via self-reported PRISMA-7 during the eligibility screening; 3) frequent emergency care (\>=1 VA emergency department visit in past year via CDW); 4) polypharmacy (\>=10 prescribed medications via CDW), or 5) significant treatment burden (score \>22 on the self-reported Multimorbidity Treatment Burden Questionnaire at study screening).
* 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 and/or missing phone number
* Missing address
* Diagnosis of dementia or severe cognitive impairment within last year
* Diagnosis of end stage renal disease or on dialysis within last year
* Receipt of palliative or hospice care in the past year
* Receipt of nursing home care in past year (Stop codes: 650, 651,119,121)
* Currently living in a nursing home, skilled nursing facility, rehabilitation facility, or long-term care facility
* Behavior flags in EHR
* Active treatment for non-melanoma skin cancer diagnosis
* Diagnosis of substance use dependence/abuse disorder in last year (excluding tobacco)
* Diagnosis of psychotic disorder in last year
* Pregnant or planning to become pregnant in next 6 months
* Score of \>8 (severe risk) on self-reported AUDIT-C questions on eligibility screen
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kristen E. Gray, PhD MS BS

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Katherine D Hoerster, PhD MPH BA

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Gray KE, Williams JL, Rivera-Remines A, Fennell T, Rao M, Rogers T, Taylor L, Nelson KM, Hoerster KD. Protocol for VetASSIST: A randomized controlled trial to evaluate virtual peer health coaching for veterans with multimorbidity. Contemp Clin Trials. 2025 Oct;157:108045. doi: 10.1016/j.cct.2025.108045. Epub 2025 Aug 14.

Reference Type DERIVED
PMID: 40818733 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIR 21-100

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Value For Veterans (V4V)
NCT05026684 UNKNOWN NA
M2VA Pain Care Pathway
NCT06526143 RECRUITING NA
The Fit With Us Study
NCT06207084 RECRUITING NA