Hypertension (HTN)SDM in BPNCT07909161
Team-Based Shared Decision-Making Program in Hypertension Control (Healthy Heart - BP Program)
A study testing Telehealth SDM visits focus on medication management and health behavior change, Self-monitored health behaviors and medications via Healthy Heart and Self-measured blood pressure (SMBP) in people with Hypertension (HTN) and Blood Pressure, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN), Blood Pressure
- What is being tested?
- Telehealth SDM visits focus on medication management and health behavior change, Self-monitored health behaviors and medications via Healthy Heart and Self-measured blood pressure (SMBP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are adults aged 18 years or older,
- Diagnosis of HTN (defined by ICD-10 code),
- Have elevated systolic blood pressure measure (≥140/90 mm Hg) on the most recent clinic visit,
- Receives primary medical care at participating JHCP practices.
- Access to smart phone or tablet to use app.
Who cannot join
- Have a diagnosis of cardiovascular disease
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer),
- Cognitive impairment or other condition preventing participation in the intervention
- Currently participating in other program to reduce BP,
- Planning to leave the practice or move out of the geographic area in 3 months,
- Unwillingness to provide informed consent
- Unable to speak, read, or communicate in English.
- Care partners will not be enrolled in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Preliminary Efficacy of a Team-Based Shared Decision-Making Program to Improve Medication Adherence and Health Behaviors in Hypertension Control
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.
Read the detailed description
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.
- Conditions
- Hypertension (HTN), Blood Pressure
- Being tested
- Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN control, Nurse-led Team-Based SDM on health behavior change and medication management for HTN control, Telehealth SDM visits focus on medication management and health behavior change, Self-monitored health behaviors and medications via Healthy Heart, Self-measured blood pressure (SMBP)
- Keywords
- Shared decision-making, Hypertension, Behavioral counseling, Medication adherence
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN controlBehavioural
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.
Nurse-led Team-Based SDM on health behavior change and medication management for HTN controlBehavioural
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.
Telehealth SDM visits focus on medication management and health behavior changeBehavioural
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.
Self-monitored health behaviors and medications via Healthy HeartBehavioural
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.
Self-measured blood pressure (SMBP)Behavioural
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.
Care partners (family/caregivers) supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| A. Pharmacist-led team-based shared decision-making program | Experimental | 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. Receives: 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 |
| B. Nurse-led, pharmacist-supported team-based shared decision-making program | Experimental | 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. Receives: 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 |
| Usual care | No intervention | Participants in the arm will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percentage of eligible participants who enroll in the study.
Measured: 12 weeks
Retention rate
Percentage of participants who complete the intervention and follow-up assessments.
Measured: 12 weeks
Survey completion rate
Proportion of participants completing baseline and follow-up surveys.
Measured: 12 weeks
Intervention completion rate
Proportion of participants who receive the shared decision-making intervention as intended.
Measured: 12 weeks
Pharmacist/Nurse Intervention Fidelity Rate
Extent to which the decision aid and associated intervention components are delivered as planned.
Measured: 12 weeks
Systolic blood pressure (SBP)
Change in systolic blood pressure (mmHg) from baseline to 12-week follow-up
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheryl R. Himmelfarb, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909161
- Sponsor's protocol ID
- IRB00533674
- Acronym
- SDM in BP
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Team-Based Shared Decision-Making Program to Improve Medication Adherence and Health Behaviors in Hypertension Control
- ClinicalTrials.gov ID
- NCT07909161
- Acronym / sponsor ID
- SDM in BP / IRB00533674
- Conditions
- Hypertension (HTN), Blood Pressure
- Keywords
- Shared decision-making, Hypertension, Behavioral counseling, Medication adherence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A. Pharmacist-led team-based shared decision-making program | Experimental | 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) supportParticipants 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. |
| B. Nurse-led, pharmacist-supported team-based shared decision-making program | Experimental | 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) supportParticipants 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. |
| Usual care | No intervention | –Participants in the arm will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are adults aged 18 years or older,
- Diagnosis of HTN (defined by ICD-10 code),
- Have elevated systolic blood pressure measure (≥140/90 mm Hg) on the most recent clinic visit,
- Receives primary medical care at participating JHCP practices.
- Access to smart phone or tablet to use app.
Key exclusion criteria (8 listed)
- Have a diagnosis of cardiovascular disease
- Serious medical condition which either limits life expectancy or requires active management (e.g., cancer),
- Cognitive impairment or other condition preventing participation in the intervention
- Currently participating in other program to reduce BP,
- Planning to leave the practice or move out of the geographic area in 3 months,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led Team-Based SDM on health behavior change and medication management for HTN controlPatients 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. | Behavioural | A. Pharmacist-led team-based shared decision-making program |
| Nurse-led Team-Based SDM on health behavior change and medication management for HTN controlPatients 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. | Behavioural | B. Nurse-led, pharmacist-supported team-based shared decision-making program |
| Telehealth SDM visits focus on medication management and health behavior changePharmacist-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. | Behavioural | A. Pharmacist-led team-based shared decision-making program, B. Nurse-led, pharmacist-supported team-based shared decision-making program |
| Self-monitored health behaviors and medications via Healthy HeartPatients 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. | Behavioural | A. Pharmacist-led team-based shared decision-making program, B. Nurse-led, pharmacist-supported team-based shared decision-making program |
| 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. | Behavioural | A. Pharmacist-led team-based shared decision-making program, B. Nurse-led, pharmacist-supported team-based shared decision-making program |
| Care partners (family/caregivers) supportDuring 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. | Behavioural | A. Pharmacist-led team-based shared decision-making program, B. Nurse-led, pharmacist-supported team-based shared decision-making program |
Primary outcome
Recruitment rate
Time frame: 12 weeks
Percentage of eligible participants who enroll in the study.
Retention rate
Time frame: 12 weeks
Percentage of participants who complete the intervention and follow-up assessments.
Survey completion rate
Time frame: 12 weeks
Proportion of participants completing baseline and follow-up surveys.
Intervention completion rate
Time frame: 12 weeks
Proportion of participants who receive the shared decision-making intervention as intended.
Pharmacist/Nurse Intervention Fidelity Rate
Time frame: 12 weeks
Extent to which the decision aid and associated intervention components are delivered as planned.
Systolic blood pressure (SBP)
Time frame: 12 weeks
Change in systolic blood pressure (mmHg) from baseline to 12-week follow-up
3 secondary outcomes
Medication adherence as assessed by the Medication Adherence Report Scale-10 (MARS-10)
Time frame: 12 weeks
Shared Decision-Making (SDM) level as assessed by the CollaboRATE survey
Time frame: 12 weeks
Patients' perceptions of involvement in shared decision-making as assessed by the Patient SDM Questionnaire (SDM-Q-9)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryl R. Himmelfarb, PhD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth SDM visits focus on medication management and health behavior change, Self-monitored health behaviors and medications via Healthy Heart and Self-measured blood pressure (SMBP) in people with Hypertension (HTN) and Blood Pressure, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuling Chen, PhD (4436835040, ychen408@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.