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

NCT06963970 | Not Yet Recruiting

• 2 other identifiers: SDR 24-0781l01HX003922-01A1
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Cancer; Renal Disease; Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Zarit-12 Cargiver Burden Interview

  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

  baseline and 6 months

Secondary Outcomes (3)

• 1-item CAHPS Global Satisfaction Measure

  baseline and 6 months

• Warwick Edinburgh Mental Well-Being Scale

  baseline and 6 months

• Connection Measure

  baseline and 6 months

Study Arms (2)

Community Health Worker support

EXPERIMENTAL

Additional weekly remote support of care partner using a trained/certified community health worker

Other: Remote Community Health Worker support

Regular support

NO INTERVENTION

Regular care

Interventions

Remote Community Health Worker support OTHER

trained/certified community health worker supporting care partner remotely

Community Health Worker support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• years old or older and able to communicate in English by phone (for assessments)

You may not qualify if:

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

Sponsors & Collaborators

• Durham VA Medical Center: collaborator
• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Dementia; Neoplasms; Kidney Diseases; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nathan A Boucher, DrPH

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer B Zervakis, PhD

CONTACT

(919) 286-0411; jennifer.zervakis@va.gov

Nathan A Boucher, DrPH

CONTACT

(919) 286-0411; nathan.boucher@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study staff collecting baseline and 6 month measures will be masked to the arm enrollment of participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)