CommunityRx-Cardiovascular Disease (CRx-CVD)

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?

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 Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Self Efficacy
• Intervention / Treatment: Other: HealtheRx

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Rocky Mount, North Carolina, United States, 27801
      • OIC Family Medical Center - Fairview
    • Rocky Mount, North Carolina, United States, 27804
      • OIC Family Medical Center - Happy Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; This group will receive the intervention

Other: HealtheRx; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. We will report counts with percentages pre- and post-intervention.	Baseline, up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 following responses will be assessed: Yes, no, don't know, refused. We will report counts and percentages for knowledge of 0, 1, 2, 3 or 4 or more resource types pre- and post-intervention.	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 following responses will be assessed: Yes, no, don't know, refused. We will report counts and percentages for utilization of 0, 1, 2, 3 or 4 or more resource types pre- and post-intervention	Baseline, up to 6 months

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Gaurav Dave, MBBS, DrPH, Unviersity of North Carolina at Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2024
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: February 9, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular disease; social determinants of health; self efficacy; rural health; health related social needs
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 23-0254; R01HL150909 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No