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

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Opt-Out Recruitment; Behavioral: Opt-In Recruitment

• Registration Number: NCT04714398
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-19
• Study Start: 2021-02-26
• Primary Completion: 2022-03-21
• Study Completion: 2022-08-26
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 425

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opt-Out	Opt-Out 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.
Opt-In Recruitment	Opt-In Recruitment	All recruitment messaging will be framed for patients as they must opt-in to participate in the remote monitoring program.

Primary Outcome Measures

Name	Time	Method
Proportion Participating by Recruitment Method	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

Name	Time	Method
Blood Pressure Trajectory by Recruitment Method	6 months, from date of consent to end of remote monitoring program	The systolic and diastolic blood pressure trajectory by recruitment arm.
Proportion Engaged by Recruitment Method	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
Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care	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).
Proportion of BP Measurements Submitted by Recruitment Method	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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States