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

NCT07662616 | Not Yet Recruiting Early Phase 1

• 2 other identifiers: IRB0055654926RIRA1635044
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

shared decision-making; Cardiovascular-kidney-metabolic; Behavioral counseling; Team-based care

Outcome Measures

Primary Outcomes (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.

  6 months

Secondary Outcomes (5)

• Health-related quality of life as assessed by the Short Form Health Survey - 12

  3 months and 6 months

• Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18

  3 months and 6 months

• Shared Decision-Making (SDM) level as assessed by the Collaborate survey

  3 months and 6 months

• Medication adherence as assessed by the Medication Adherence Report Scale -10

  3 months and 6 months

• Patients' perceptions of involvement in SDM as assessed by the Patient SDM questionnaire - 9

  3 months and 6 months

Study Arms (2)

Team-based shared decision-making

EXPERIMENTAL

Participants in the intervention arm will receive team-based shared decision-making intervention and usual care.

Combination Product: Team-based shared decision-making

Usual care

NO INTERVENTION

Participants in the arm will receive usual care.

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.

Team-based shared decision-making

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus; Hyperlipidemias; Kidney Diseases; Obesity; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cheryl Himmelfarb, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuling Chen, PhD

CONTACT

443-683-5040; ychen408@jh.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share