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MultimorbidityVetASSISTNCT05560451

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

A study testing Peer health coach intervention in people with Multimorbidity, run by VA Office of Research and Development at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multimorbidity
What is being tested?
Peer health coach intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
1 siteUnited States
Study dates
19 Oct 2023to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Corporate Data Warehouse (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)
  • Inclusion criteria assessed via the phone screen includes frailty; treatment burden; and willingness to use a either a phone or an Internet-connected device with a web camera and an email address and/or ability to receive text messages to ensure receipt of VVC visit links
  • Agree to participate in the health coaching sessions and surveys if assigned to intervention group

Who cannot join

  • 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
Show all 15Show fewer
  • 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 Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questions on eligibility screen

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Seattle, Washington, 98108-1532

Other trials in United States

About this study

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.

Read the 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.

Conditions
Multimorbidity
Being tested
Peer health coach intervention
Keywords
Peer health coaching, Health-related quality of life, Veterans, Multimorbidity, Self-management, Social support, Multiple chronic conditions, Telemedicine
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peer health coach interventionBehavioural

    Also called VetASSIST

    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.

Study groups in NCT05560451
Study groupRoleWhat they receive
Peer health coach interventionExperimentalParticipants 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.
Receives: Behavioral: Peer health coach intervention
Control group/no interventionNo interventionParticipants will continue to receive their regular, usual primary care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to 12-months

Secondary outcomes (2)

  1. Change in mental health quality of life (HRQoL)

    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

    Measured: Baseline to 12-months

  2. Health care utilization

    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.

    Measured: Baseline to 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start19 Oct 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
298 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560451
Sponsor's protocol ID
IIR 21-100
Acronym
VetASSIST
Status last verified
Sep 2026
First submitted
26 Sep 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kramer CB, Nelson KM, Sayre G, Williams JL, Spruill L, Fennell T, Gray KE, Weiner BJ, Fan V, Jones-Smith J, Rao M. "Veteran to Veteran, There's Automatically a Trust": A Qualitative Study of Veterans' Experiences in a Peer Health-Coaching Program for Hypertension. AJPM Focus. 2024 Jul 3;3(6):100257. doi: 10.1016/j.focus.2024.100257. eCollection 2024 Dec.

    PubMed 39415799

  • 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.

    PubMed 40818733

Questions about this trial

What is this clinical trial studying?

A study testing Peer health coach intervention in people with Multimorbidity, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in physical health related quality of life (HRQoL) (time frame: Baseline to 12-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560451, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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