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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06963970
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VA Office of Research and Development
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nathan A Boucher, DrPH
Principal Investigator Affiliation Durham VA Medical Center, Durham, NC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

U.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dementia, Cancer, Renal Disease, Obstructive Pulmonary Disease
Additional Details

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.

Arms & Interventions

Arms

Experimental: Community Health Worker support

Additional weekly remote support of care partner using a trained/certified community health worker along with regular support from Caregiver Support Program

No Intervention: Regular support

Regular support from Caregiver Support Program ONLY

Interventions

Other: - Remote Community Health Worker support

trained/certified community health worker supporting care partner remotely

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Durham VA Medical Center, Durham, NC, Durham 4464368, North Carolina 4482348

Status

Address

Durham VA Medical Center, Durham, NC

Durham 4464368, North Carolina 4482348, 27705-3875

Site Contact

David Edelman, MD MHS

[email protected]

919-286-6936

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