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

NCT04714398 | Completed

• 1 other identifier: 844150
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

blood pressure; remote monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Proportion Engaged by Recruitment Method

  6 months, from date of consent to end of remote monitoring period

• Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care

  6 months, from date of consent to end of remote monitoring program

• Blood Pressure Trajectory by Recruitment Method

  6 months, from date of consent to end of remote monitoring program

• Proportion of BP Measurements Submitted by Recruitment Method

  6 months, from date of consent to end of remote monitoring program

Study Arms (3)

Opt-In Recruitment

EXPERIMENTAL

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

Behavioral: Opt-In Recruitment

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.

Behavioral: Opt-Out Recruitment

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.

Interventions

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.

Opt-In Recruitment

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.

Opt-Out

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Must have a cellular phone with texting capabilities
• Must be prescribed at least one medication for hypertension

You may not qualify if:

• Has metastatic (Stage IV) cancer
• Has end stage renal disease
• Has congestive heart failure
• Has dementia
• BMI \>= 50
• Is Non-English speaking requiring a translator

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 40892409 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shivan Mehta, MD, MBA

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: February 26, 2021
• Primary Completion: March 21, 2022
• Study Completion: August 26, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)