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NCT Number: NCT07662616

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

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Key information

Conditions

Hypertension (HTN) Body Weight Cardiovascular Diseases Cardiovascular-kidney-metabolic (CKM) Diabetes (DM) Diabetes Mellitus Dyslipidemias Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperlipidaemia Hyperlipidemias Hypertension Kidney Disease Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

30 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Team-based shared decision-making

Combination Product
  • 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).
  • 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

  1. Life's Essential 8 (LE8)

    Time frame: 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.

Secondary outcomes

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

    Time frame: 3 months and 6 months

    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.

  2. Patient satisfaction as assessed by the Patient Satisfaction Questionnaire - 18

    Time frame: 3 months and 6 months

    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.

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

    Time frame: 3 months and 6 months

    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.

  4. Medication adherence as assessed by the Medication Adherence Report Scale -10

    Time frame: 3 months and 6 months

    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.

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

    Time frame: 3 months and 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuling Chen, PhD

CONTACT

[email protected]

443-683-5040

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Acronym: SDM in CKM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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