DementiaPATHNCT06963970
Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans
A study testing Remote Community Health Worker support in people with Dementia and Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cancer, Renal Disease
- What is being tested?
- Remote Community Health Worker support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Can live with or separately from the Veteran; able to communicate in English by phone
- Veteran Inclusion Criteria Receiving VA care at HSA 2.1 (North Carolina and Virginia) (at least 2 encounters in past year, has a PACT/primary care provider)
- Residing in a rural area based on RUCA Rural Urban Commuting Codes
- Diagnosed with Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, cancer, dementia, or End-Stage Renal Disease.
- Requires assistance with at least one activities of daily living (ADLs) or instrumental activities of daily living (IADL)
- 65 years old or older and able to communicate in English by phone (for assessments)
Who cannot join
- Care partner Exclusion Criteria
- -Enrolled in Caregiver Support Program (CSP)
- Veteran Exclusion Criteria
- Flag or social work note indicating suspected Caregiver abuse
- Unable to communicate in English by phone for assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Jennifer B Zervakis, PhD, (919) 286-0411 ext. 176174, jennifer.zervakis@va.gov
Nathan A Boucher, DrPH
About this study
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.
Read the 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. 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-12 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 Satisfaction 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 Scale 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.
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.
- Conditions
- Dementia, Cancer, Renal Disease, Obstructive Pulmonary Disease
- Being tested
- Remote Community Health Worker support
- Medical subject headings
- Dementia, Neoplasms, Kidney Diseases, Lung Diseases, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Community Health Worker supportOther
Trained/certified community health worker supporting care partner remotely
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker support | Experimental | Additional weekly remote support of care partner using a trained/certified community health worker Receives: Other: Remote Community Health Worker support |
| Regular support | No intervention | Regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and 6 months
Secondary outcomes (3)
1-item CAHPS Global Satisfaction Measure
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.
Measured: baseline and 6 months
Warwick Edinburgh Mental Well-Being Scale
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
Measured: baseline and 6 months
Connection Measure
- 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
- 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
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start2 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dyads of seriously ill veterans and their care partners. Care Partners will receive the intervention. The control arm is care partners with usual care. The intervention arm is care partners receiving a study-provided community health worker for additional support along with usual care. Being enrolled in the Caregiver Support Program at time of enrollment is an exclusion. A total of 240 pairs of veteran and care partners will be enrolled (120 pairs in the intervention, and 120 pairs in the control arm). While only care partners receive the intervention and complete the primary outcome measure, the 480 enrollment number refers to the total number of care partners+veterans consented.
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Durham VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Nathan A Boucher, DrPH, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963970
- Sponsor's protocol ID
- SDR 24-078
- Other IDs
- 1l01HX003922-01A1
- Acronym
- PATH
- Status last verified
- Oct 2026
- First submitted
- 1 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Community Health Workers to Support Rural Care Partners of Seriously Ill Older Veterans
- ClinicalTrials.gov ID
- NCT06963970
- Acronym / sponsor ID
- PATH / SDR 24-078
- Conditions
- Dementia, Cancer, Renal Disease, Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Durham VA Medical Center
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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-12 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 Satisfaction 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 Scale 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dyads of seriously ill veterans and their care partners. Care Partners will receive the intervention. The control arm is care partners with usual care. The intervention arm is care partners receiving a study-provided community health worker for additional support along with usual care. Being enrolled in the Caregiver Support Program at time of enrollment is an exclusion. A total of 240 pairs of veteran and care partners will be enrolled (120 pairs in the intervention, and 120 pairs in the control arm). While only care partners receive the intervention and complete the primary outcome measure, the 480 enrollment number refers to the total number of care partners+veterans consented.
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker support | Experimental | Other: Remote Community Health Worker supportAdditional weekly remote support of care partner using a trained/certified community health worker |
| Regular support | No intervention | –Regular care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Can live with or separately from the Veteran; able to communicate in English by phone
- Veteran Inclusion Criteria Receiving VA care at HSA 2.1 (North Carolina and Virginia) (at least 2 encounters in past year, has a PACT/primary care provider)
- Residing in a rural area based on RUCA Rural Urban Commuting Codes
Key exclusion criteria (5 listed)
- Care partner Exclusion Criteria
- -Enrolled in Caregiver Support Program (CSP)
- Veteran Exclusion Criteria
- Flag or social work note indicating suspected Caregiver abuse
- Unable to communicate in English by phone for assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Community Health Worker supportTrained/certified community health worker supporting care partner remotely | Other | Community Health Worker support |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan A Boucher, DrPH principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Community Health Worker support in people with Dementia and Cancer, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer B Zervakis, PhD ((919) 286-0411 ext. 176174, jennifer.zervakis@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit-12 Cargiver Burden Interview (time frame: baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.