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

NCT04714398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2022-09-19

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Shivan Mehta, MD, MBA · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-26
Primary Completion
2022-03-21
Completion
2022-08-26

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714398 on ClinicalTrials.gov