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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt-In Recruitment | Experimental | All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program. |
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| Opt-Out | Experimental | All recruitment messaging will be framed as though participation is the default, and patients must opt-out of participating in the remote monitoring program. |
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| Usual Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opt-In Recruitment | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Participating by Recruitment Method | The proportion of patients participating in each study arm out of the number randomized to that study arm. | 6 months, from date of consent to end of remote monitoring program |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Engaged by Recruitment Method | The proportion of patients recruited by each method who are actively engaged with the program | 6 months, from date of consent to end of remote monitoring period |
| Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shivan Mehta, MD, MBA | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40892409 | Derived | Mehta SJ, Teel J, Okorie E, Reitz C, Purcell A, Snider CK, Clark K, Kersting RC, Glanz K, Putt M, Rareshide C, Volpp KG. Behavioral Economic Framing for Enrollment and Retention of Patients in Remote Blood Pressure Monitoring: A Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529825. doi: 10.1001/jamanetworkopen.2025.29825. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Opt-Out Recruitment | Behavioral | 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. |
|
The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care). |
| 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. | 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 | 6 months, from date of consent to end of remote monitoring program |