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

• ClinicalTrials.gov Identifier: NCT04714398
• Recruitment Status: Active, not recruiting
• First Posted: January 19, 2021
• Last Update Posted: December 15, 2021
• Sponsor: University of Pennsylvania
• Information provided by (Responsible Party): Shivan J Mehta, University of Pennsylvania

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Hypertension	Behavioral: Opt-In Recruitment; Behavioral: Opt-Out Recruitment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 425 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: SupportBP 2.0: Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management
• Actual Study Start Date: February 26, 2021
• Estimated Primary Completion Date: March 2022
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Opt-In Recruitment; All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.	Behavioral: 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.
Experimental: 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.	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.
No Intervention: 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.

Outcome Measures

Primary Outcome Measures :

1. Proportion Participating by Recruitment Method [ Time Frame: 6 months, from date of consent to end of remote monitoring program ]
   The proportion of patients participating in each study arm out of the number randomized to that study arm.

Secondary Outcome Measures :

1. Proportion Engaged by Recruitment Method [ Time Frame: 6 months, from date of consent to end of remote monitoring period ]
   The proportion of patients recruited by each method who are actively engaged with the program
2. Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care [ Time Frame: 6 months, from date of consent to end of remote monitoring program ]
   The proportion with controlled blood pressure by remote monitoring and the proportion with controlled blood pressure by clinic visits (usual care).
3. Blood Pressure Trajectory by Recruitment Method [ Time Frame: 6 months, from date of consent to end of remote monitoring program ]
   The systolic and diastolic blood pressure trajectory by recruitment arm.
4. Proportion of BP Measurements Submitted by Recruitment Method [ Time Frame: 6 months, from date of consent to end of remote monitoring program ]
   The proportion of requested BP measurements submitted by each patient by recruitment arm

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

• Principal Investigator: Shivan Mehta, MD, MBA; University of Pennsylvania

More Information

• Responsible Party: Shivan J Mehta, Principal Investigator, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04714398
• Other Study ID Numbers: 844150
• First Posted: January 19, 2021
• Last Update Posted: December 15, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shivan J Mehta, University of Pennsylvania:

blood pressure; remote monitoring

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases