Skip to main content
Clinical Trials/NCT06264726
NCT06264726CompletedNot Applicable

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

University of North Carolina, Chapel Hill2 sites in 1 country308 target enrollmentStarted: March 12, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
308
Locations
2
Primary Endpoint
Change in Participant Self-efficacy for Finding Community Resources

Study 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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);
  • •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

Arms & Interventions

Intervention Group

Experimental

This group will receive the intervention

Intervention: HealtheRx (Other)

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.

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials