Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06963970

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dementia Brain Diseases Cancer Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders Obstructive Pulmonary Disease Renal Disease Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location contact

Jennifer B Zervakis, PhD

CONTACT

[email protected]

(919) 286-0411 ext. 176174

Nathan A Boucher, DrPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote Community Health Worker support

Other

trained/certified community health worker supporting care partner remotely

Primary outcomes

  1. Zarit-12 Cargiver Burden Interview

    Time frame: baseline and 6 months

    Care 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 outcomes

  1. 1-item CAHPS Global Satisfaction Measure

    Time frame: baseline and 6 months

    Care 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.

  2. Warwick Edinburgh Mental Well-Being Scale

    Time frame: baseline and 6 months

    Veterans 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

  3. Connection Measure

    Time frame: baseline and 6 months

    • 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

    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer B Zervakis, PhD

CONTACT

[email protected]

(919) 286-0411 ext. 176174

Nathan A Boucher, DrPH

CONTACT

[email protected]

(919) 286-0411 ext. 177764

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Durham VA Medical Center

Registry information

Acronym: PATH

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 9, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.