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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04714398
• Other study ID #: 844150
• Status: Completed
• Phase: N/A
• Start date: February 26, 2021
• Est. completion date: August 26, 2022

Study information

• Verified date: September 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: August 26, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion with Controlled Blood Pressure by Monitoring vs. Usual Care	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
Secondary	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
Secondary	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