NCT05560451

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Oct 2023Sep 2026

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 19, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

October 21, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

September 26, 2022

Last Update Submit

October 16, 2025

Conditions

Keywords

Peer health coachingHealth-related quality of lifeVeteransMultimorbiditySelf-managementSocial supportMultiple chronic conditionsTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Change in physical health related quality of life (HRQoL)

    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

    Baseline to 12-months

Secondary Outcomes (2)

  • Change in mental health quality of life (HRQoL)

    Baseline to 12-months

  • Health care utilization

    Baseline to 12-months

Other Outcomes (13)

  • Self-efficacy

    Baseline to 12-months

  • Patient activation

    Baseline to 12-months

  • Social support

    Baseline to 12-months

  • +10 more other outcomes

Study Arms (2)

Peer health coach intervention

EXPERIMENTAL

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

Control group/no intervention

NO INTERVENTION

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

Interventions

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.

Also known as: VetASSIST
Peer health coach intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kristen E. Gray, PhD MS BS

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

    PRINCIPAL INVESTIGATOR
  • Katherine D Hoerster, PhD MPH BA

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

October 19, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

October 21, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations