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
Conditions:
🦠 Cardiovascular Diseases 🦠 Self Efficacy
🗓️ Study Start (Actual) 12 March 2024
🗓️ Primary Completion (Estimated) 12 March 2025
✅ Study Completion (Estimated) 12 March 2025
👥 Enrollment (Estimated) 325
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Rocky Mount, North Carolina, United States
📍 Rocky Mount, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 2 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 February 2024
  • First Submitted that Met QC Criteria 9 February 2024
  • First Posted 20 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 April 2024
  • Last Update Posted 12 April 2024
  • Last Verified April 2024