ClinicalTrials.gg
Active, not recruitingNCT05560451VetASSISTUpdated Sep 14, 2026

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

An interventional study of Peer health coach intervention in Multimorbidity, sponsored by VA Office of Research and Development. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
298
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Multimorbidity

Keywords

  • Peer health coaching
  • Health-related quality of life
  • Veterans
  • Multimorbidity
  • Self-management
  • Social support
  • Multiple chronic conditions
  • Telemedicine
03

In context

Multiple Chronic Conditions

89 studies on the registry are indexed under Multiple Chronic Conditions; 16 are open to participants now.

This study's enrollment of 298 is above the median of 128 across 71 interventional studies indexed under Multiple Chronic Conditions.

Browse Multiple Chronic Conditions studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion criteria

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 Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) questions on eligibility screen
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
298 participants (actual)

Study arms

  • 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

  • No intervention
    Control group/no intervention

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

Interventions

  • BehavioralPeer 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.

    Also known as: VetASSIST

06

What researchers measure

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

    Time frame: Baseline to 12-months

Secondary outcomes

  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

    Time frame: 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.

    Time frame: Baseline to 12-months

Other outcomes

  1. Patient activation

    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.

    Time frame: Baseline to 12-months

  2. Social support

    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.

    Time frame: Baseline to 12-months

  3. Shared decision-making

    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.

    Time frame: Baseline to 12-months

  4. Diet quality

    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.

    Time frame: Baseline to 12-months

  5. Medication adherence

    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.

    Time frame: Baseline to 12-months

  6. Tobacco use

    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).

    Time frame: Baseline to 12-months

  7. Alcohol use

    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.

    Time frame: Baseline to 12-months

  8. Sleep impairment/disturbance

    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.

    Time frame: Baseline to 12-months

  9. Physical activity

    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.

    Time frame: Baseline to 12-months

07

Study locations

1 site
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Dec 2026, 38 months after the start.

Of 59 non-industry interventional studies with no phase under Multiple Chronic Conditions, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 37. This study's planned 38 months is above that.

Counting every sponsor, half of 59 studies reached it within 20 months; a quarter within 11 and three quarters within 37.

Multiple Chronic Conditions covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 26, 2022
First posted
Sep 29, 2022
StartActual
Oct 19, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 30, 2027
Last update
Sep 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05560451
Responsible party
Sponsor
First posted
Sep 29, 2022
Start date
Oct 19, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Kristen E. Gray, PhD MS BS
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA
Katherine D Hoerster, PhD MPH BA
principal investigator · VA Puget Sound Health Care System Seattle Division, Seattle, WA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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