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Behavioural Intervention

Intervention Group for Cardiovascular Disease (CRx-CVD Trial)

N/A
Recruiting
Led By Gaurav Dave, MBBS, DrPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be age 2 or older
Patient must 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 to 130 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 to 126 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 to 150mg/dL), ICD-9 or 10 diagnostic code for hyperlipidemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 6 months
Awards & highlights

CRx-CVD Trial Summary

This trial aims to test how providing rural African American patients with information about community resources can help improve their confidence in using these resources. Participants will receive personalized information on resources related to food, housing, transportation

Who is the study for?
This trial is for rural African American patients with cardiovascular disease who are interested in improving their ability to use community resources. Participants should be willing to receive a personalized HealtheRx resource, interact with a community resource navigator if needed, and get reminder texts about these services.Check my eligibility
What is being tested?
The study tests the 'HealtheRx' intervention—a personalized list of local resources like food and housing support—on patient self-efficacy in managing health-related social needs. It's a pre-test post-test design where participants' confidence in using community resources is measured before and after receiving the HealtheRx.See study design
What are the potential side effects?
Since this trial involves providing information rather than medical treatment, traditional physical side effects are not expected. However, there may be indirect effects on stress or anxiety levels due to dealing with new information and navigating additional services.

CRx-CVD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am at least 2 years old.
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I have a condition like high blood pressure, diabetes, or am overweight.

CRx-CVD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in participant self-efficacy for finding community resources
Secondary outcome measures
Change in participant knowledge of community resources
Change in participant utilization of community resources

CRx-CVD Trial Design

1Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
This group will receive the intervention

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,841 Previous Clinical Trials
47,813,780 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,500 Total Patients Enrolled
Gaurav Dave, MBBS, DrPHPrincipal InvestigatorUnviersity of North Carolina at Chapel Hill

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still able to enroll in this research study at the moment?

"As per the details provided on clinicaltrials.gov, recruitment for this trial is presently closed. The initial posting date was 2/19/2024, with the latest update on 2/9/2024. Notwithstanding its current inactivity, there are currently 506 alternative studies actively seeking participant involvement."

Answered by AI
~217 spots leftby Mar 2025