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OpenTrials
Completed

NCT Number: NCT06264726

CommunityRx-Cardiovascular Disease

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

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Key information

Conditions

Cardiovascular Diseases Self Efficacy

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Change in participant knowledge of community resources

    Time frame: 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.

  2. Change in participant utilization of community resources

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: CRx-CVD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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