Clinical trial NCT06963970: Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans
Official title: Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia
Cancer
Renal Disease
Obstructive Pulmonary Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-05-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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 (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.

Eligibility criteria: 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 Codes83
* Must be enrolled in 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 ADL (i.e., walking, feeding, toileting, transferring, bathing, or dressing) or 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 Exclusion Criteria

* Flag or social work note indicating suspected Caregiver abuse.
* Unable to communicate in English by phone for assessments.

Primary outcomes:
measure: Zarit-12 Cargiver Burden Interview
timeFrame: baseline and 6 months
Secondary outcomes:
measure: 1-item CAHPS Global Satisfaction Measure
timeFrame: baseline and 6 months
measure: Warwick Edinburgh Mental Well-Being Scale
timeFrame: baseline and 6 months
measure: Connection Measure
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Nathan A Boucher, DrPH
role: PRINCIPAL_INVESTIGATOR
References: