Clinical trial

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

Opening soon · Early Phase 1 · 0 countries · Registry ID NCT07662616

Opening soonEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 79 Years

SexAll

Healthy volunteersNot accepted

ConditionHypertension (HTN), Diabetes (DM), Hyperlipidaemia, Kidney Disease, Obesity, Cardiovascular-kidney-metabolic (CKM), Overweight

Full registry criteria

Inclusion Criteria: * Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD), * 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. Exclusion Criteria: * Have diagnosis of CVD, * Stage 4-5 CKD, kidney failure, or on dialysis * Have a serious medical condition such as cancer; * On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months; * 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.

Treatments and study arms

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.

Primary outcomes

Life's Essential 8 (LE8)6 months

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.

Study locations

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No public site location was included in this record. Check the original registry for updates.