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Heart to Heart for High Blood Pressure
N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants: Age 18 or older
Participants: Has blood pressure readings with uncontrolled blood pressure, defined as exceeding the blood thresholds for initiation of antihypertensive medication according to the 2017 American College of Cardiology/ American Heart Association (ACC/AHA) guidelines
Must not have
Participants: Has a medical condition that prohibits or severely restricts ability to eat vegetables (i.e., renal disease, Crohn's disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at baseline and 6 months and 12 months after start of the intervention
Awards & highlights
Summary
This trial is testing whether a church-based intervention can reduce blood pressure in African Americans with uncontrolled blood pressure.
Who is the study for?
This trial is for African American adults with uncontrolled high blood pressure who attend church regularly and can join weekly Zoom meetings. Eligible churches must have a majority of African American members and be able to recruit participants. People unable to make dietary changes or give informed consent, planning to move soon, or with certain medical conditions are excluded.
What is being tested?
The study tests 'Heart to Heart', a heart health intervention, and 'Money Smart', a financial wellness program in churches over 12 months. It's randomized, meaning participants are put into groups by chance to compare the effects on blood pressure control among African Americans.
What are the potential side effects?
Since this trial focuses on behavioral interventions like education and lifestyle changes rather than medication, side effects may include discomfort from lifestyle adjustments or stress from participating in regular meetings.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My blood pressure is higher than the recommended levels.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot eat vegetables due to a severe medical condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at baseline and 6 months and 12 months after start of the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at baseline and 6 months and 12 months after start of the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Blood pressure
Secondary study objectives
Change in Barriers to medication use
Change in DASH diet adherence
Change in Hypertension knowledge
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Heart to HeartExperimental Treatment1 Intervention
Group II: Money SmartActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Heart to Heart
2012
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
431 Previous Clinical Trials
158,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot eat vegetables due to a severe medical condition.I am 18 years old or older.I can attend weekly meetings on Zoom.This criterion refers to the inclusion of churches where the majority of the members are African American.My blood pressure is higher than the recommended levels.You can't change your diet because you don't have control over where your food comes from (for example, you eat meals at a shelter or nursing home).It seems like the given statement is not a clinical trial exclusion criterion. If you have a different clinical trial exclusion criterion that needs to be rewritten, feel free to provide it and I will be happy to help!You have participated in a previous ALIVE intervention.I attend church services at least once a month.You have a medical condition that makes it hard to predict your health for the next six months.
Research Study Groups:
This trial has the following groups:- Group 1: Heart to Heart
- Group 2: Money Smart
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.
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