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Multicomponent Intervention for High Blood Pressure (IMPACTS Trial)
N/A
Waitlist Available
Led By Jiang He, MD, PhD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 30 months
Awards & highlights
IMPACTS Trial Summary
This trial is testing a strategy to help lower blood pressure in people at risk for heart disease, while also assessing how well the strategy works in real-world settings.
Eligible Conditions
- High Blood Pressure
IMPACTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 30 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 30 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in a fidelity summary score for key implementation strategy components during the 18-month intervention.
Difference in mean change of systolic BP
Secondary outcome measures
Acceptance to intensive BP target by providers in intervention clinics
Adherence to clinical appointments in the intervention group
Adherence to health coach session in the intervention group
+11 moreOther outcome measures
Intensification of Treatment (fidelity)
Medication Adherence (fidelity)
Other implementation outcomes: acceptability, adoption, appropriateness, and feasibility
IMPACTS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Multicomponent InterventionExperimental Treatment1 Intervention
Protocol-based treatment using the SPRINT stepped-care intensive BP management algorithm, dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification
Group II: Enhanced Usual CareActive Control1 Intervention
Webinar education session for providers on the new ACC/AHA hypertensive clinical guideline and the SPRINT study findings
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multicomponent Intervention
2022
N/A
~1700
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Who is running the clinical trial?
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
225,296 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,833 Previous Clinical Trials
47,305,290 Total Patients Enrolled
Jiang He, MD, PhDPrincipal Investigator - Tulane University
Tulane University
9 Previous Clinical Trials
26,425 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are not planning to switch to a different primary healthcare provider outside of the clinic for the next 18 months.Your blood pressure is consistently high, even with medication.You have a history of heart problems, chronic kidney disease, diabetes, or a high risk of developing heart disease within the next 10 years.You cannot participate in the trial if your close family members work at the clinic where the study is being conducted.Men or women who are at least 40 years old and receive their main health care from the participating FQHC clinics.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: Multicomponent Intervention
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.
Is this study still enrolling patients?
"The clinicaltrial.gov website confirms that this study is still actively recruiting patients. This particular trial was first posted on June 27th, 2018 and the most recent update was September 19th, 2022. They are hoping to enroll 1260 people at 2 different locations."
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