An Early Phase 1 interventional study of Team-based shared decision-making in Hypertension (HTN), Diabetes (DM) and Hyperlipidaemia, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Johns Hopkins University · Early Phase 1, Interventional, and Prevention
The investigators are proposing a new team-based shared decision-making (SDM) program. The goal of this study is to see whether this program is practical and whether it may help adults with cardiometabolic risk factors and cardiovascular-kidney-metabolic syndrome. The investigators will enroll adults from a primary care clinic in Maryland. People in the intervention group will take part in the 6-month program in addition to usual care. People in the control group will receive usual care only.
The investigators proposed a novel team-based shared decision-making (SDM) program. The overall goal of this proposal is to conduct a pilot randomized controlled trial to evaluate the SDM intervention compared to usual care among 94 adult patients with cardiometabolic factors and cardiovascular-kidney-metabolic (CKM) syndrome at a primary care clinic in Maryland. Participants in the intervention group will receive the 6-month intervention and usual care, while those in the control group will receive usual care. Specific aims include:
Aim 1: To evaluate the feasibility of the Team-Based SDM Program. Feasibility outcomes include recruitment, retention, intervention adherence, and fidelity.
Aim 2: To assess the preliminary efficacy of the Team-Based SDM Program versus usual care in improving clinical, patient-reported, and patient-centered outcomes at 12 weeks post-intervention
Aim 3: To examine the preliminary efficacy of the Team-Based SDM Program versus usual care in improving patients' life's essential 8 and medication adherence from baseline to 6 months.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 94 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.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 19, 2026. See what changed
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:
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.
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.
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 team-based shared decision-making intervention and usual care.
Combination Product: Team-based shared decision-making
Participants in the arm will receive usual care.
1. Patients use the Healthy Heart Patient Decision Aid (PtDA) to prepare for the SDM and track progress: Patients will use the Healthy Heart to self-assess baseline LE8 scores, medication adherence, preferences, and Social Determinants of Health (SDOH) before meeting with pharmacist and primary care providers (PCPs). 2. Pharmacist-led telehealth SDM visits focus on medication management and lifestyle modifications. The baseline telehealth visit (30-45 minutes) will provide participants with SDM training and the use of Healthy Heart PtDA and assess patients' medications and lifestyle. Follow-up telehealth visits (30 minutes) will be conducted biweekly in the first 2 months and monthly in 3-6 months. Follow-ups will discuss available options, goals, and strategies tailored to the patient's needs and preferences based on the AHA's CKM management algorithm for stage 2 CKM.4 Pharmacist will engage patients in discussions about alternative medication options for metabolic risk factors.
Life's Essential 8 (LE8)
Change in mean LE8 scores from baseline to 6 months post-randomization compared to usual care. LE8 scores ranged from 0 to 100, with higher scores indicating better cardiovascular health.
Time frame: 6 months
Health-related quality of life as assessed by the Short Form Health Survey - 12
Patient-centered and patient-reported outcomes - health-related quality of life as measured by the 12-item Short Form Health Survey (SF-12). The SF-12 scores ranged from 0 to 100 and higher scores indicate better health.
Time frame: 3 months and 6 months
Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18
The Patient Satisfaction Questionnaire (PSQ-18) Short Form. The PSQ-18 scores ranged from 18 to 90, and higher scores reflect better satisfaction with medical care.
Time frame: 3 months and 6 months
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 ranged from 0-27, with higher scores indicating better SDM level.
Time frame: 3 months and 6 months
Medication adherence as assessed by the Medication Adherence Report Scale -10
Mean scores of medication adherence 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: 3 months and 6 months
Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9
Mean scores of patients' perceptions of involvement in SDM assessed by the Patient SDM Questionnaire (SDM-Q-9). The scores ranged from 0 to 45, and higher scores indicate better involvement in SDM.
Time frame: 3 months and 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Mar 2028, 17 months later.
Of 44 non-industry phase 1 interventional studies under Hypertension, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12. This study's planned 17 months is below that.
Counting every sponsor, half of 175 studies reached it within 4 months; a quarter within 1 and three quarters within 17.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, on Oct 19, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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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