Your session is about to expire
← Back to Search
Behavioral Intervention
Intervention Program for Coronary Heart Disease
N/A
Recruiting
Led By Sanjay Rajagopalan, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
40 to 75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after cessation of intervention or 24 months after enrollment
Awards & highlights
Study Summary
This trial is reducing cardiometabolic health disparities & lifespan inequality in Detroit & Cleveland by providing an evidence-based intervention program & training to optimize CHW competence & adherence.
Who is the study for?
This trial is for Black or African American individuals aged 40-75 living in the Cleveland Metro Area, with certain risk factors like high body mass index (BMI), history of smoking, elevated blood pressure, high HbA1c or LDL levels. They must be able to undergo a coronary artery calcium score test and consent to treatment by a UH provider within their insurance coverage.Check my eligibility
What is being tested?
Project 3: ACHIEVE-CHD is testing an intervention program called PAL2 delivered by Community Health Workers. It's part of a larger effort to reduce health disparities in heart disease management among populations at risk in Detroit and Cleveland.See study design
What are the potential side effects?
Since this study involves non-drug interventions using community health workers and lifestyle modification programs, typical medication side effects are not expected. However, participants may experience stress or discomfort related to changes in diet or exercise routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 75 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after cessation of intervention or 24 months after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after cessation of intervention or 24 months after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Triple Goal
Secondary outcome measures
Change in HbA1c as measured by blood work
Change in LDL-C as measured by blood work
Change in blood pressure
+1 moreOther outcome measures
Health Visits and Lifestyle Changes - Activity
Health Visits and Lifestyle Changes - Diet
Health Visits and Lifestyle Changes - Medical/Mental Health Visits
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Low CVD riskExperimental Treatment1 Intervention
PAL2
Group II: High CVD riskExperimental Treatment1 Intervention
Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA)
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
318 Previous Clinical Trials
339,585 Total Patients Enrolled
Sanjay Rajagopalan, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center
2 Previous Clinical Trials
137 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is very high (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg).I need extra oxygen to breathe properly.I have a history of heart or blood vessel disease.I am currently receiving treatment for cancer.You live in the Cleveland Metro Area.I am between 40 and 75 years old.
Research Study Groups:
This trial has the following groups:- Group 1: High CVD risk
- Group 2: Low CVD risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being sought for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, the aforementioned medical trial is actively recruiting participants as of this time. Initially posted on August 15th 2022 and most recently edited on June 15th 2023, 500 volunteers are sought from one site."
Answered by AI
Does the trial accept senior citizens beneath a certain age limit?
"This research is open to individuals between the ages of 40 and 75."
Answered by AI
Is there still space available for participants in this investigation?
"As confirmed on clinicaltrials.gov, this trial is actively recruiting candidates and has undergone frequent updates since it was first posted on August 15th 2022. The latest update occured June 15th 2023."
Answered by AI
Who meets the requirements for joining this medical research?
"In order to participate in this experiment, candidates must have coronary heart disease and be within the age range of 40-75. This research endeavour is seeking to enrol a total of 500 participants."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger