An interventional study of Remote Community Health Worker support in Dementia, Cancer and Renal Disease, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Supportive care
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.
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.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 480 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 22, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Care Partner Inclusion Criteria
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)
Exclusion Criteria:
Care partner Exclusion Criteria
-Enrolled in Caregiver Support Program (CSP)
Veteran Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Additional weekly remote support of care partner using a trained/certified community health worker
Other: Remote Community Health Worker support
Regular care
Trained/certified community health worker supporting care partner remotely
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
Time frame: baseline and 6 months
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.
Time frame: 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
Time frame: baseline and 6 months
Connection Measure
1. 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 2. 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
Time frame: baseline and 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 25 months is close to that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Apr 2028 → Dec 2028 and completion Sep 2028 → Sep 2029.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development →