An interventional study of Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN control and Nurse-led Team-Based SDM on health behavior change and medication management for HTN control in Hypertension (HTN) and Blood Pressure, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
In the Nurse-Led Team-Based SDM group, pharmacist will serve as a consultant to provide recommendations for medication regimens. Each participant will receive a home blood pressure monitor and continuous care from the patient's clinician at the usual care source. The intervention for all groups will last for 12 weeks. The results of this pilot study will offer valuable insights and will help shape the design of a larger randomized controlled trial (RCT) to evaluate the efficacy and effectiveness of the proposed Team-Based SDM Program in managing HTN. The investigators will enroll a total of 90 adults with uncontrolled HTN.
The primary aim of the study is to evaluate the feasibility and acceptability of the Team-Based SDM Program in supporting SDM for both medication management and health behavior change among patients with uncontrolled HTN.
The secondary aim of the study is to test the preliminary efficacy of the Team-Based SDM Program in change of mean systolic BP from baseline to 12-weeks post intervention among patients with uncontrolled HTN.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Care partners will not be enrolled in the study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the intervention arm will receive pharmacist-led team-based shared decision-making intervention and usual care focusing on health behavior change and medication management for hypertension management.
Behavioral: Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN control · Behavioral: Telehealth SDM visits focus on medication management and health behavior change · Behavioral: Self-monitored health behaviors and medications via Healthy Heart · Behavioral: Self-measured blood pressure (SMBP) · Behavioral: Care partners (family/caregivers) support
Participants in the intervention arm will receive a nurse-led with the support of a pharmacist team-based shared decision-making intervention and usual care focusing on health behavior change and medication management for hypertension management.
Behavioral: Nurse-led Team-Based SDM on health behavior change and medication management for HTN control · Behavioral: Telehealth SDM visits focus on medication management and health behavior change · Behavioral: Self-monitored health behaviors and medications via Healthy Heart · Behavioral: Self-measured blood pressure (SMBP) · Behavioral: Care partners (family/caregivers) support
Participants in the arm will receive usual care.
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.
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.
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.
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.
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.
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.
Recruitment rate
Percentage of eligible participants who enroll in the study.
Time frame: 12 weeks
Retention rate
Percentage of participants who complete the intervention and follow-up assessments.
Time frame: 12 weeks
Survey completion rate
Proportion of participants completing baseline and follow-up surveys.
Time frame: 12 weeks
Intervention completion rate
Proportion of participants who receive the shared decision-making intervention as intended.
Time frame: 12 weeks
Pharmacist/Nurse Intervention Fidelity Rate
Extent to which the decision aid and associated intervention components are delivered as planned.
Time frame: 12 weeks
Systolic blood pressure (SBP)
Change in systolic blood pressure (mmHg) from baseline to 12-week follow-up
Time frame: 12 weeks
Medication adherence as assessed by the Medication Adherence Report Scale-10 (MARS-10)
Scores range from 0 to 50, or 0 to 10 depending on the exact scoring format used. Higher scores consistently indicate a higher level of medication adherence.
Time frame: 12 weeks
Shared Decision-Making (SDM) level as assessed by the CollaboRATE survey
Shared Decision-Making (SDM) level will be measured by the CollaboRATE survey. The CollaboRATE scores range from 0-27, with higher scores indicating better SDM level.
Time frame: 12 weeks
Patients' perceptions of involvement in shared decision-making as assessed by the Patient SDM Questionnaire (SDM-Q-9)
Mean scores of patients' perceptions of involvement in SDM assessed by the Patient SDM Questionnaire (SDM-Q-9). Scores range from 0 to 45, and higher scores indicate better involvement in SDM.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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