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Opt-In Recruitment for High Blood Pressure
N/A
Waitlist Available
Led By Shivan Mehta, MD, MBA
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 18 and 75 years old with HTN (ICD-10 code I10)
Has had at least one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if >60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, from date of consent to end of remote monitoring period
Awards & highlights
Study Summary
This study is evaluating whether different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN) are effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months, from date of consent to end of remote monitoring period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, from date of consent to end of remote monitoring period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion Participating by Recruitment Method
Secondary outcome measures
Blood Pressure Trajectory by Recruitment Method
Proportion Engaged by Recruitment Method
Proportion of BP Measurements Submitted by Recruitment Method
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Opt-OutExperimental Treatment1 Intervention
All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program.
Group II: Opt-In RecruitmentExperimental Treatment1 Intervention
All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.
Group III: Usual CareActive Control1 Intervention
Patients in the usual care arm will not be contacted by study staff, they will not receive a blood pressure cuff, and they will not be asked to participate in any component of the blood pressure monitoring program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opt-Out Recruitment
2021
N/A
~430
Opt-In Recruitment
2021
N/A
~430
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,993 Previous Clinical Trials
42,875,034 Total Patients Enrolled
Shivan Mehta, MD, MBAPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
22,510 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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