Clinical Trials Directory

Trials / Completed

CompletedNCT04714398

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
425 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALOpt-In RecruitmentPatients 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.
BEHAVIORALOpt-Out RecruitmentPatients 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.

Timeline

Start date
2021-02-26
Primary completion
2022-03-21
Completion
2022-08-26
First posted
2021-01-19
Last updated
2022-09-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04714398. Inclusion in this directory is not an endorsement.