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Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06963970
Acronym
PATH
Enrollment
480
Registered
2025-05-09
Start date
2026-11-02
Completion date
2028-09-30
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Dementia, Obstructive Pulmonary Disease, Renal Disease

Brief summary

The investigators aim to support care partner's well-being and satisfaction with VA care and decrease their work burden by offering extra support from a trained Community Health Worker who will help connect the care partner to helpful resources in their communities and in the VA. The investigators also hope to help Veterans well-being and satisfaction with VA care by supporting their care partner more sufficiently allowing the care partner to focus on caregiving tasks.

Detailed description

Aim 1: Determine CSNAV effectiveness in increasing rural Veterans' well-being, reducing rural care partner burden, and increasing rural care partner/Veteran satisfaction with VA care in the intervention group compared with the usual care Caregiver Support Program (CSP) group. The investigators will apply a 6-month intervention in a randomized control trial over 27 months. Primary Outcome: (H1) Care partners randomized to intervention group will have lower mean Zarit-1216 burden scores at 6 months compared to the control group. Secondary Outcomes: (H2) Care partners and Veterans randomized to the intervention group will have higher mean CAHPS Global Satisfaction17 scores at 6 months compared to the control group. (H3) Veterans randomized to the intervention group will have higher mean Warwick Edinburgh Mental Well-Being Scale18 scores at 6 months compared to the control group. Aim 2: Following intervention, the investigators explore Veterans' and care partners' experience of CHWs as a mode of VA support using semi-structured interviews. The investigators then facilitate Delphi Method sessions with the Community Advisory Board plus study Veterans/care partners, CHWs, and key operational partners to examine Aims 1 & 2 data for intervention improvements and implementation planning using updated CFIR.19 Aim 3: Conduct budget impact analysis from the VA perspective to evaluate cost-drivers and assess feasibility to inform adaptation and implementation of the intervention within a VA regional network.

Interventions

OTHERRemote Community Health Worker support

Trained/certified community health worker supporting care partner remotely

Sponsors

VA Office of Research and Development
Lead SponsorFED
Durham VA Medical Center
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Study staff collecting baseline and 6 month measures will be masked to the arm enrollment of participants.

Intervention model description

Enrolled Care Partners are randomized to the study. The control arm is care partners of seriously ill Veterans who are enrolled in the Caregiver Support Program and the intervention arm is care partners of seriously ill Veterans who are enrolled in the Caregiver Support Program PLUS receiving a study-provided community health worker for additional support.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Care Partner Inclusion Criteria * A relative, friend, or partner (18 years of age) with whom Veteran patient has a personal relationship who assists Veteran regularly with care and/or care coordination as defined under "Veterans" below * Residing in a rural area based on RUCC or Rural-Urban Continuum Codes 83 * Must be enrolled in Caregiver Support Program (CSP) Program of General Caregiver Support Services * Can live with or separately from the Veteran; able to communicate in English by phone Veteran Inclusion Criteria * Receiving care at Durham, Asheville, and Richmond VA Health Systems (e.g., at least 2 outpatient visits in past year; has a primary provider) and residing in a rural area. * Diagnosed with congestive heart failure, chronic obstructive pulmonary disease, cancer, dementia, or end-stage renal disease. * Requires assistance with at least one Activities of daily living (ADLs) (i.e., walking, feeding, toileting, transferring, bathing, or dressing) or Instrumental activities of daily living (IADL) (i.e., transport, medication, financial management, shopping, or meal preparation) * 50 years old or older and able to communicate in English by phone (for assessments)

Exclusion criteria

Veteran

Design outcomes

Primary

MeasureTime frameDescription
Zarit-12 Cargiver Burden Interviewbaseline and 6 monthsCare partners randomized to intervention will have lower mean Zarit-12 scores at 6 months compared to the control group. Each question is scored on a five-point Likert scale from 0 to 4, with higher scores representing a greater feeling of burden. The total ZBI-12 score is the summation of 12 items, with a total score range from 0 to 484. Higher indicates more burden. A cut-off score of 13 points on the ZBI-12 is suggested for screening burden in community-dwelling older caregivers, but should not be assumed as normative data. 5 categories: health, psychological well-being, finances, social life, relationship with impaired person. 12 item, α=0.88-0.91

Secondary

MeasureTime frameDescription
1-item CAHPS Global Satisfaction Measurebaseline and 6 monthsCare partners and Veterans randomized to intervention will have higher mean 1-item CAHPS Global Satisfaction scores at 6 months compared to the control group. Scale of 0 to 10 to measure respondents' overall assessments of a provider, care, and/or healthcare organization. Higher score means a more satisfied.
Warwick Edinburgh Mental Well-Being Scalebaseline and 6 monthsVeterans randomized to intervention will have higher mean Warwick Edinburgh Mental Well-Being Scale scores at 6 months compared to the control group. 14 item scale (scored 1-5) of mental well-being covering subjective well-being and psychological functioning, in which all items are worded positively and address aspects of positive mental health. The minimum scale score is 14 and the maximum is 70, higher is more positive well-being. α=0.89-0.91
Connection Measurebaseline and 6 months1. At baseline and 6 months. "When I need services at the VA, I was connected to those services" Strongly Agree-Agree-Disagree-Strongly Disagree Scale o At 6 months only: In what ways has connecting to services at VA changed for you since the beginning of the study? Open-ended response 2. At baseline and 6 months. "When I need services in my community, I was connected to those services" Strongly Agree-Agree-Disagree-Strongly Disagree Scale * At 6 months only: In what ways has connecting to services in the community changed for you since the beginning of the study? Open-ended response

Countries

United States

Contacts

CONTACTJennifer B Zervakis, PhD
jennifer.zervakis@va.gov(919) 286-0411
CONTACTNathan A Boucher, DrPH
nathan.boucher@va.gov(919) 286-0411
PRINCIPAL_INVESTIGATORNathan A Boucher, DrPH

Durham VA Medical Center, Durham, NC

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026