Clinical trial NCT06264726: CommunityRx-Cardiovascular Disease
Official title: CommunityRx-Cardiovascular Disease: Implementation of the HealtheRx to Reduce Health Inequity in Rural Eastern North Carolina
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Self Efficacy
Keywords: cardiovascular disease
social determinants of health
rural health
health related social needs
self efficacy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-02-20
Enrollment: 325
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in participant self-efficacy for finding community resources
timeFrame: Baseline, up to 6 months
Secondary outcomes:
measure: Change in participant knowledge of community resources
timeFrame: Baseline, up to 6 months
measure: Change in participant utilization of community resources
timeFrame: Baseline, up to 6 months
Other outcomes:
Locations:
city: Rocky Mount
country: United States
facility: OIC Family Medical Center - Fairview
state: North Carolina
city: Rocky Mount
country: United States
facility: OIC Family Medical Center - Happy Hill
state: North Carolina
Study officials:
affiliation: Unviersity of North Carolina at Chapel Hill
name: Gaurav Dave, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
References: