CommunityRx-Cardiovascular Disease

NCT06264726 | Completed

• 2 other identifiers: 23-0254R01HL150909
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 2

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

Conditions

Cardiovascular Diseases; Self Efficacy

Keywords

cardiovascular disease; social determinants of health; rural health; health related social needs; self efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (1)

Intervention Group

EXPERIMENTAL

This group will receive the intervention

Other: HealtheRx

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

OIC Family Medical Center - Fairview

Rocky Mount, North Carolina, 27801, United States

Location

OIC Family Medical Center - Happy Hill

Rocky Mount, North Carolina, 27804, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Gaurav Dave, MBBS, DrPH

  Unviersity of North Carolina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: March 12, 2024
• Primary Completion: October 28, 2025
• Study Completion: October 28, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC

Locations

US (2)