AzTrials
AzTrials

Hypertension (HTN)Early Phase 1SDM in CKMNCT07662616

Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health (Healthy Heart - CKM)

A Early Phase 1 study testing Team-based shared decision-making in people with Hypertension (HTN) and Diabetes (DM), run by Johns Hopkins University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension (HTN), Diabetes (DM), Hyperlipidaemia
What is being tested?
Team-based shared decision-making
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 30 Jun 2028
Phase
Early Phase 1
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,
  • Are in stage 2 CKM: the presence of metabolic risk factors (hypertension [stages 1 and 2], hypertriglyceridemia [≥135 mg/dL], diabetes, Metabolic Equivalents (MetS)*) and/or Chronic Kidney Disease (CKD) [moderate- to high-risk CKD which are stages 1-3 CKD]), and
  • Receive primary care at Johns Hopkins Community Physicians (JHCP).
  • Access to smart phone or tablet to use app.

Who cannot join

  • Have diagnosis of CVD,
  • Stage 4-5 CKD, kidney failure, or on dialysis
  • Have a serious medical condition such as cancer;
  • Have cognitive impairment;
  • Are currently involved in other programs on improving LE8; or
  • Unwillingness to provide informed consent
  • Unable to speak, read, or communicate in English.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yuling Chen, PhD contact

443-683-5040

ychen408@jh.edu

About this study

Official title: Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health

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.

Read the detailed description

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.

Being tested
Team-based shared decision-making
Keywords
shared decision-making, Cardiovascular-kidney-metabolic, Behavioral counseling, Team-based care
Medical subject headings
Hypertension, Diabetes Mellitus, Hyperlipidemias, Kidney Diseases, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Team-based shared decision-makingCombination product

    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.
Study groups in NCT07662616
Study groupRoleWhat they receive
Team-based shared decision-makingExperimentalParticipants in the intervention arm will receive team-based shared decision-making intervention and usual care.
Receives: Combination Product: Team-based shared decision-making
Usual careNo interventionParticipants in the arm will receive usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 months

Secondary outcomes (5)

  1. 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.

    Measured: 3 months and 6 months

  2. 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.

    Measured: 3 months and 6 months

  3. 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.

    Measured: 3 months and 6 months

  4. 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.

    Measured: 3 months and 6 months

  5. 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.

    Measured: 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662616
Sponsor's protocol ID
IRB00556549
Other IDs
26RIRA1635044
Acronym
SDM in CKM
Status last verified
Oct 2026
First submitted
17 Jun 2026
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Team-based shared decision-making in people with Hypertension (HTN) and Diabetes (DM), 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 4 inclusion and 7 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 19 Oct 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 (443-683-5040, ychen408@jh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Life's Essential 8 (LE8) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662616.

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 19 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in