Cardiovascular DiseasesCRx-CVDNCT06264726
CommunityRx-Cardiovascular Disease
A study testing HealtheRx in people with Cardiovascular Diseases and Self Efficacy, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Cardiovascular Diseases, Self Efficacy
- What is being tested?
- HealtheRx
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2024to 28 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient
- African American
- age 2 or older
- Have at least one cardiometabolic condition:
- Overweight (BMI greater than or equal to 25 kg/m^2);
- Obesity (BMI greater than or equal to 30 kg/m^2);
Show all 17Show fewer
- ICD-9 or 10 diagnostic code for overweight or obesity
- Adult prehypertension (SBP 120 to 129 and DBP greater than 80 mmHg);
- Adult hypertension (SBP greater than or equal to130 or DBP = 80 mmHg);
- Pediatric Prehypertension (SBP or DBP greater than or equal to 90th but <95th percentile)
- Pediatric Hypertension (SBP or DBP greater than or equal to 95th percentile);
- ICD-9 or 10 diagnostic code for hypertension
- Adult and Pediatric Prediabetes (Fasting glucose 100-125 mg/dL or OGTT 140-199 mg/dL)
- Adult and Pediatric Diabetes (FPG greater than or equal to126 mg/dL (7.0 mmol/L) or OGTT greater than or equal to 200 mg/dL (11.1mmol/L) or HgbA1C greater than or equal to 6.5);
- ICD-9 or 10 diagnostic code for diabetes, pre-diabetes or elevated glucose, or gestational diabetes;
- Adult and Pediatric Total cholesterol (>200mg/dL; LDL >130mg/dL; HDL < 35 mg/dL; TG greater than or equal to150mg/dL);
- ICD-9 or 10 diagnostic code for hyperlipidemia
Who cannot join
- Unable to read, speak or understand English
- Unable to receive text message or email communications
- Living in the same household as someone already enrolled in the CRx-CVD study
- Adults with limited life expectancy (e.g., advanced cancer, end stage liver disease, hospice)
- Adults receiving treatment for cancer
- Adults living in skilled nursing facilities
- Dementia/other significant cognitive impairment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OIC Family Medical Center - Fairview
Rocky Mount, North Carolina, 27801
OIC Family Medical Center - Happy Hill
Rocky Mount, North Carolina, 27804
About this study
Official title: CommunityRx-Cardiovascular Disease: Implementation of the HealtheRx to Reduce Health Inequity in Rural Eastern North Carolina
The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:
- What is the effectiveness of community resource information on patient self-efficacy to use community resources?
Read more
Participants will be given:
- A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
- Access to a community resource navigator for support with using the HealtheRx upon request
- 2 text messages with reminders about the HealtheRx and access to the community resource navigator
- Conditions
- Cardiovascular Diseases, Self Efficacy
- Being tested
- HealtheRx
- Keywords
- cardiovascular disease, social determinants of health, rural health, health related social needs, self efficacy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealtheRxOther
CRx-CVD intervention provides participants with a HealtheRx, a tool developed by researchers with personalized listings of community resources with information about housing, food assistance, utility support, transportation and crisis support for patients. A HealtheRx may can be given directly, texted or emailed to patients and caregivers. All patients enrolled in this group will receive the HealtheRx either via text and/or email based on participant preference. Participants will receive contact information for a Community Resource Navigator who can provide support with using the HealtheRx, provide additional resources upon request, and answer any questions the participant may have. Participants will also receive a 2 reminder text messages over 2 months following their initial receipt of the HealtheRx. The SMS messages offer reminders about the HealtheRx and ongoing community resource navigation support.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | This group will receive the intervention Receives: Other: HealtheRx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Participant Self-efficacy for Finding Community Resources
Change in self-efficacy for finding community resources is measured using one item constructed from Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from 1= "not at all confident" to 5= "completely confident." Lower scores indicate lower levels of confidence, and higher scores indicate higher levels of confidence.
Measured: Baseline, up to 6 months
Secondary outcomes (2)
Change in Participant Knowledge of Community Resources
Change in participant knowledge of community resources is measured using 10 self-reported survey items adapted and tested in prior CommunityRx studies asking, "For each place that I list, please tell me if you know of places like this in your community: [insert community resource]." The change in the mean number of "yes" responses will be reported.
Measured: Baseline, up to 6 months
Change in Participant Utilization of Community Resources
Change in participant utilization of community resources is measured using 10 self-reported survey items adapted and tested in prior CommunityRx studies asking participants "Have you received services from places like this for you or your household in the last 6 months?" The change in the mean number of "yes" responses will be reported.
Measured: Baseline, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start12 Mar 2024
- Primary completion28 Oct 2025
- Study completion28 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Gaurav Dave, MBBS, DrPH, Principal investigator, Unviersity of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264726
- Sponsor's protocol ID
- 23-0254
- Other IDs
- R01HL150909
- Acronym
- CRx-CVD
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2024
- Last updated
- 24 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx-Cardiovascular Disease: Implementation of the HealtheRx to Reduce Health Inequity in Rural Eastern North Carolina
- ClinicalTrials.gov ID
- NCT06264726
- Acronym / sponsor ID
- CRx-CVD / 23-0254
- Conditions
- Cardiovascular Diseases, Self Efficacy
- Keywords
- cardiovascular disease, social determinants of health, rural health, health related social needs, self efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 28 Oct 2025 (actual)
- Study completion
- 28 Oct 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 24 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this single arm pre-test post-test design study is to test the impact of providing patients with information about community-based resources to address health-related social needs and cardiometabolic health in rural African American patients. The main question it aims to answer is:
- What is the effectiveness of community resource information on patient self-efficacy to use community resources?
Participants will be given:
- A personalized "HealtheRx" resource with information about community resources related to food, housing, utility support, transportation, and crisis support. The HealtheRx is personalized for patients based on their age and zip code.
- Access to a community resource navigator for support with using the HealtheRx upon request
- 2 text messages with reminders about the HealtheRx and access to the community resource navigator
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: HealtheRxThis group will receive the intervention |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- patient
- African American
- age 2 or older
- Have at least one cardiometabolic condition:
Key exclusion criteria (7 listed)
- Unable to read, speak or understand English
- Unable to receive text message or email communications
- Living in the same household as someone already enrolled in the CRx-CVD study
- Adults with limited life expectancy (e.g., advanced cancer, end stage liver disease, hospice)
- Adults receiving treatment for cancer
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 |
|---|---|---|
| HealtheRxCRx-CVD intervention provides participants with a HealtheRx, a tool developed by researchers with personalized listings of community resources with information about housing, food assistance, utility support, transportation and crisis support for patients. A HealtheRx may can be given directly, texted or emailed to patients and caregivers. All patients enrolled in this group will receive the HealtheRx either via text and/or email based on participant preference. Participants will receive contact information for a Community Resource Navigator who can provide support with using the HealtheRx, provide additional resources upon request, and answer any questions the participant may have. Participants will also receive a 2 reminder text messages over 2 months following their initial receipt of the HealtheRx. The SMS messages offer reminders about the HealtheRx and ongoing community resource navigation support. | Other | Intervention Group |
Primary outcome
Change in Participant Self-efficacy for Finding Community Resources
Time frame: Baseline, up to 6 months
Change in self-efficacy for finding community resources is measured using one item constructed from Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from 1= "not at all confident" to 5= "completely confident." Lower scores indicate lower levels of confidence, and higher scores indicate higher levels of confidence.
2 secondary outcomes
Change in Participant Knowledge of Community Resources
Time frame: Baseline, up to 6 months
Change in Participant Utilization of Community Resources
Time frame: Baseline, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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. This study is not recruiting at the moment.
Gaurav Dave, MBBS, DrPH principal investigator
Unviersity of North Carolina at Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealtheRx in people with Cardiovascular Diseases and Self Efficacy, run by University of North Carolina, Chapel Hill at 2 sites 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 17 inclusion and 7 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: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 24 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Participant Self-efficacy for Finding Community Resources (time frame: Baseline, up to 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 24 Sep 2026.