Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health

Sponsor
Johns Hopkins University
Study ID
NCT07662616
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular-kidney-metabolic (CKM)
  • Diabetes (DM)
  • Hyperlipidaemia
  • Hypertension (HTN)
  • Kidney Disease
  • Obesity
  • Overweight

Eligibility Criteria

Sex
ALL
Age
30 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Team-based shared decision-making — COMBINATION_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 Details

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.

Key Dates

First listed
Jun 23, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Team-based shared decision-making
    Participants in the intervention arm will receive team-based shared decision-making intervention and usual care.
  • No Intervention: Usual care
    Participants in the arm will receive usual care.

Primary Outcome Measure

Life's Essential 8 (LE8) [ Time Frame: 6 months ]

Central Contacts

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