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Clinical Trials/NCT05560451
NCT05560451
Active, not recruiting
Not Applicable

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

VA Office of Research and Development1 site in 1 country298 target enrollmentOctober 19, 2023
ConditionsMultimorbidity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multimorbidity
Sponsor
VA Office of Research and Development
Enrollment
298
Locations
1
Primary Endpoint
Change in physical health related quality of life (HRQoL)
Status
Active, not recruiting
Last Updated
6 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2023
End Date
September 30, 2026
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).
  • 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

  • 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

Outcomes

Primary Outcomes

Change in physical health related quality of life (HRQoL)

Time Frame: 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 Outcomes

  • Change in mental health quality of life (HRQoL)(Baseline to 12-months)
  • Health care utilization(Baseline to 12-months)

Study Sites (1)

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