CommunityRx-Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

— CRx-CVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264726
• Other study ID #: 23-0254
• Secondary ID: R01HL150909
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: March 12, 2025

Study information

• Verified date: April 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Gaurav Dave, MBBS, DrPH
• Phone: (919) 843-8271
• Email: gjdave[@]unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 325
• Est. completion date: March 12, 2025
• Est. primary completion date: March 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Self Efficacy

Intervention

Other:
• HealtheRx
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.

Locations

Country	Name	City	State
United States	OIC Family Medical Center - Fairview	Rocky Mount	North Carolina
United States	OIC Family Medical Center - Happy Hill	Rocky Mount	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in participant knowledge of community resources	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.	Baseline, up to 6 months
Secondary	Change in participant utilization of community resources	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	Baseline, up to 6 months