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CommunityRx-Cardiovascular Disease (CRx-CVD)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Active, not recruiting

Conditions

Self Efficacy
Cardiovascular Diseases

Treatments

Other: HealtheRx

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06264726
R01HL150909 (U.S. NIH Grant/Contract)
23-0254

Details and patient eligibility

About

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

Enrollment

325 estimated patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

325 participants in 1 patient group

Intervention Group
Experimental group
Description:
This group will receive the intervention
Treatment:
Other: HealtheRx

Trial contacts and locations

2

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Central trial contact

Giselle Corbie, MD, MSc; Gaurav Dave, MBBS, DrPH

Data sourced from clinicaltrials.gov

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