CommunityRx-Cardiovascular Disease

NCT ID: NCT06264726

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2025-10-30

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

Conditions

Cardiovascular Diseases; Self Efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention Group

This group will receive the intervention

Group Type: EXPERIMENTAL

HealtheRx

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaurav Dave, MBBS, DrPH

Role: PRINCIPAL_INVESTIGATOR

Unviersity of North Carolina at Chapel Hill

Locations

OIC Family Medical Center - Fairview

Rocky Mount, North Carolina, United States

OIC Family Medical Center - Happy Hill

Rocky Mount, North Carolina, United States

Countries

United States

Other Identifiers

R01HL150909

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-0254

Identifier Type: -

Identifier Source: org_study_id