SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management

NCT ID: NCT04714398

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 425 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2022-08-26

Brief Summary

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).

Detailed Description

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:

1. Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.

2. Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Opt-In Recruitment

All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.

Group Type: EXPERIMENTAL

Opt-In Recruitment

Intervention Type: 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.

Opt-Out

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 Type: EXPERIMENTAL

Opt-Out Recruitment

Intervention Type: 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.

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Opt-In Recruitment

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.

Intervention Type: BEHAVIORAL

Opt-Out Recruitment

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Between 18 and 75 years old with HTN (ICD-10 code I10)

2. 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).

3. Must have a cellular phone with texting capabilities

4. Must be prescribed at least one medication for hypertension

Exclusion Criteria

1. Has metastatic (Stage IV) cancer

2. Has end stage renal disease

3. Has congestive heart failure

4. Has dementia

5. BMI >= 50

6. Is Non-English speaking requiring a translator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Shivan J Mehta

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shivan Mehta, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40892409 (View on PubMed)

Other Identifiers

844150

Identifier Type: -

Identifier Source: org_study_id