An interventional study of Opt-In Recruitment and Opt-Out Recruitment in Hypertension, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-19.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Supportive care
A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).
The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN the investigators will:
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 425 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.
Behavioral: Opt-In Recruitment
All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program.
Behavioral: Opt-Out Recruitment
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.
Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.
Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.
Proportion Participating by Recruitment Method
The proportion of patients participating in each study arm out of the number randomized to that study arm.
Time frame: 6 months, from date of consent to end of remote monitoring program
Proportion Engaged by Recruitment Method
The proportion of patients recruited by each method who are actively engaged with the program
Time frame: 6 months, from date of consent to end of remote monitoring period
Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care
The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care).
Time frame: 6 months, from date of consent to end of remote monitoring program
Blood Pressure Trajectory by Recruitment Method
The systolic and diastolic blood pressure trajectory by recruitment arm.
Time frame: 6 months, from date of consent to end of remote monitoring program
Proportion of BP Measurements Submitted by Recruitment Method
The proportion of requested BP measurements submitted by each patient by recruitment arm
Time frame: 6 months, from date of consent to end of remote monitoring program
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania