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Clinical Trials/NCT06264726
NCT06264726
Completed
Not Applicable

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

University of North Carolina, Chapel Hill4 sites in 1 country308 target enrollmentMarch 12, 2024

Overview

Phase
Not Applicable
Intervention
HealtheRx
Conditions
Cardiovascular Diseases
Sponsor
University of North Carolina, Chapel Hill
Enrollment
308
Locations
4
Primary Endpoint
Change in participant self-efficacy for finding community resources
Status
Completed
Last Updated
11 days ago

Overview

Brief 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. 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
Registry
clinicaltrials.gov
Start Date
March 12, 2024
End Date
October 28, 2025
Last Updated
11 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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);

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

Arms & Interventions

Intervention Group

This group will receive the intervention

Intervention: HealtheRx

Outcomes

Primary Outcomes

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. We will report counts with percentages pre- and post-intervention.

Secondary Outcomes

  • Change in participant knowledge of community resources(Baseline, up to 6 months)
  • Change in participant utilization of community resources(Baseline, up to 6 months)

Study Sites (4)

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