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CompletedNCT06264726ClinicalTrials.gov record

CommunityRx-Cardiovascular Disease

Cardiovascular Diseases · Self Efficacy

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
2 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
308 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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);
  • 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

Exclusion Criteria:

  • 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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
Intervention Group

This group will receive the intervention

Other: HealtheRx

HealtheRx OTHER

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

Change in Participant Knowledge of Community Resources

Time frame: Baseline, up to 6 months

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.

Change in Participant Utilization of Community Resources

Time frame: Baseline, up to 6 months

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.

Results are posted in the registry.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (2)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

2 locations

OIC Family Medical Center - FairviewRocky Mount, North Carolina, United StatesStatus unknown
OIC Family Medical Center - Happy HillRocky Mount, North Carolina, United StatesStatus unknown

Study team and timeline

Lead sponsor
University of North Carolina, Chapel Hill
Study start
Mar 12, 2024 Actual
Primary completion
Oct 28, 2025 Actual
Study completion
Oct 28, 2025 Actual
First posted
Feb 20, 2024 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

CommunityRx-Cardiovascular Disease: Implementation of the HealtheRx to Reduce Health Inequity in Rural Eastern North Carolina

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026