CommunityRx-Cardiovascular Disease

Not Applicable

Recruiting

• Conditions: Self Efficacy; Cardiovascular Diseases
• Interventions: Other: HealtheRx

• Registration Number: NCT06264726
• Lead Sponsor: University of North Carolina, Chapel Hill

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Study Start: 2024-03-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-03-12
• Study Completion: 2025-03-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 325

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	HealtheRx	This group will receive the intervention

Primary Outcome Measures

Name	Time	Method
Change in participant self-efficacy for finding community resources	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 Outcome Measures

Name	Time	Method
Change in participant knowledge of community resources	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 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.
Change in participant utilization of community resources	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 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

Trial Locations

Locations (2)

OIC Family Medical Center - Fairview; 🇺🇸 Rocky Mount, North Carolina, United States

OIC Family Medical Center - Happy Hill; 🇺🇸 Rocky Mount, North Carolina, United States