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NOT YET RECRUITING
NCT07909161
NA

Team-Based Shared Decision-Making Program in Hypertension Control (Healthy Heart - BP Program)

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

The main goal of the study is to conduct a pilot trial to test the feasibility of the Team-Based Shared Decision-Making (SDM) Program, supported by Healthy Heart, involving 90 adults with uncontrolled hypertension (HTN) at primary care clinics. One group (Group A: 30 participants) will receive a pharmacist-led Team-Based SDM Program; one group (Group B: 30 participants) will receive a nurse-led, pharmacist-supported Team-Based SDM Program; and one group (Group C: 30 participants) will receive usual care.

Official title: Feasibility and Preliminary Efficacy of a Team-Based Shared Decision-Making Program to Improve Medication Adherence and Health Behaviors in Hypertension Control

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-10-30

Completion Date

2027-09-30

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BEHAVIORAL

Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN control

Patients and the patient's care partners will be considered to be an integral a multidisciplinary team, including Primary Care Physicians (PCPs) in the participating Johns Hopkins Community Physician (JHCP) practices, a pharmacist or a nurse, to discuss choices regarding health behaviors and medication regimens to improve BP control. The nature of SDM model of this intervention encourages patients to actively participate in healthcare decisions (focusing on health behavior change and medication management), as well as fostering an environment where the patient can express preferences and concerns. By being embedded in the team, patients will receive personalized support tailored to the patient's individual needs. The pharmacist serves a key role in promoting the SDM process.

BEHAVIORAL

Nurse-led Team-Based SDM on health behavior change and medication management for HTN control

Patients and the patient's care partners will be considered to be an integral a multidisciplinary team, including PCPs in the participating JHCP practices, a pharmacist or a nurse, to discuss choices regarding health behaviors and medication regimens to improve BP control. The nature of SDM model of this intervention encourages patients to actively participate in the patient's healthcare decisions (focusing on health behavior change and medication management), as well as fostering an environment where the patient can express preferences and concerns. By being embedded in the team, patients will receive personalized support tailored to individual needs. The nurse serves a key role in promoting the SDM process.

BEHAVIORAL

Telehealth SDM visits focus on medication management and health behavior change

Pharmacist-led or nurse-led telehealth SDM visits are flexible and personalized. The baseline telehealth visit is to provide participants with SDM training using the Healthy Heart, explain the details and duration of the intervention, and build rapport and trust. Patients will have access to the Healthy Heart during this visit, which will be used to discuss health behavior change preferences following the eight-step SDM process. ). Follow-up telehealth visits (via Zoom or telephone) will be conducted by the pharmacist or the nurse after the initial baseline visit at 2-week, 4-week, 6-week, 8-week, 10-week, and 12-week post baseline visits.

BEHAVIORAL

Self-monitored health behaviors and medications via Healthy Heart

Patients will be able to log health behaviors (e.g., dietary choices, physical activity) and medication adherence in real time. The Healthy Heart will provide pre-specified individualized feedback and recommendations based on the data entered, helping patients understand progress and areas needing improvement. A patient can also use the Healthy Heart to send messages to the pharmacist or the nurse.

BEHAVIORAL

Self-measured blood pressure (SMBP)

All participants will be provided with an Omron 10 series device which is included in the U.S. BP Validated Device Listing™ website and validated by the Association for the Advancement of Medical Instrumentation/International Organization for Standardization (AAMI/ISO) protocol. The investigators will mail the SMBP device to participants. Participant retain the SMBP device after the study has ended . A BP measurement protocol developed for LINKED-HEARTS project will be used. The participant will be asked to obtain 2 readings, 1-minute apart, in the morning after awakening, before eating and taking medications, and 2 readings, 1-minute apart, in the evening before going to bed.50 On each occasion (AM or PM), the SMBP device will automatically obtain 2 readings, 1-minute apart, after being triggered by the participant.

BEHAVIORAL

Care partners (family/caregivers) support

During baseline visits, the pharmacist or the nurse will identify family members or caregivers who play significant roles in the patient's life and can contribute to the SDM process. These individuals will be encouraged to participate in discussions about the patient's health goals and preferences. Once the care partners are added to the SDM team, patients will receive information on the patient's health condition, medication options, and the importance of health behavior change. Family members and caregivers will be invited to participate in telehealth visits, either by phone or video, allowing the patient to provide input and support during SDM discussions.