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

NCT07662616 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-08-12

No results posted yet for this study

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. 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.

Conditions

Interventions

COMBINATION_PRODUCT

Team-based shared decision-making

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.

Sponsors & Collaborators

Principal Investigators

  • Cheryl Himmelfarb, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-10
Primary Completion
2028-03-31
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662616 on ClinicalTrials.gov