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Not yet recruiting NCT06963970

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

No phase Interventional Dementia Cancer Renal Disease Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote Community Health Worker support.
Who it may be relevant to
Registry conditions: Dementia, Cancer, Renal Disease, Obstructive Pulmonary Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other Remote Community Health Worker support
    trained/certified community health worker supporting care partner remotely

Primary outcome measures

  • Zarit-12 Cargiver Burden Interview [Time frame: baseline and 6 months]
Secondary outcome measures (3)
  • 1-item CAHPS Global Satisfaction Measure [Time frame: baseline and 6 months]
  • Warwick Edinburgh Mental Well-Being Scale [Time frame: baseline and 6 months]
  • Connection Measure [Time frame: baseline and 6 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Durham VA Medical Center, Durham, NC — Durham

Identifiers

NCT: NCT06963970 · SDR 24-078 · 1l01HX003922-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗