[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053567":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":18,"responsibleParty":34,"collaborators":18,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":18,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":67,"whyStopped":18,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":18},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Team-based shared decision-making","EXPERIMENTAL","Participants in the intervention arm will receive team-based shared decision-making intervention and usual care.",[13],"Combination Product: Team-based shared decision-making",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Participants in the arm will receive usual care.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"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).\n2. 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.",[9],[25],{"name":26,"affiliation":5,"role":27},"Cheryl Himmelfarb, PhD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Yuling Chen, PhD","CONTACT","443-683-5040","ychen408@jh.edu",{"type":35,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100053567","early-phase-1-team-based-shared-decision-making-program-in-cardiovascular-kidney-metabolic-health-100053567",false,"NCT07662616","Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health","Feasibility and Efficacy Pilot of a Team-Based Shared Decision-Making Program in Cardiovascular-Kidney-Metabolic Health, Medication Adherence, and Cardiovascular Health","SDM in CKM","Inclusion Criteria:\n\n* Are adults aged 30 to 79 years (to use PREVENT equations to calculate 10- and 30-year risk estimates for total CVD),\n* Are in stage 2 CKM: the presence of metabolic risk factors (hypertension \\[stages 1 and 2\\], hypertriglyceridemia \\[≥135 mg\u002FdL\\], diabetes, Metabolic Equivalents (MetS)\\*) and\u002For Chronic Kidney Disease (CKD) \\[moderate- to high-risk CKD which are stages 1-3 CKD\\]), and\n* Receive primary care at Johns Hopkins Community Physicians (JHCP).\n* Access to smart phone or tablet to use app.\n\nExclusion Criteria:\n\n* Have diagnosis of CVD,\n* Stage 4-5 CKD, kidney failure, or on dialysis\n* Have a serious medical condition such as cancer;\n* On or planning to start Glucagon-like peptide-1 (GLP-1) receptor agonists in next 6 months;\n* Have cognitive impairment;\n* Are currently involved in other programs on improving LE8; or\n* Unwillingness to provide informed consent\n* Unable to speak, read, or communicate in English.","ALL","30 Years","79 Years",{"count":48,"type":49},94,"ESTIMATED","INTERVENTIONAL",[52],"EARLY_PHASE1","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.",[55,56,57,58,59,60,61],"Hypertension (HTN)","Diabetes (DM)","Hyperlipidaemia","Kidney Disease","Obesity","Cardiovascular-kidney-metabolic (CKM)","Overweight",[63,64,65,66],"shared decision-making","Cardiovascular-kidney-metabolic","Behavioral counseling","Team-based care","NOT_YET_RECRUITING","2026-07-10",{"date":70,"type":71},"2026-07-13","ACTUAL",{"date":73,"type":49},"2026-08-10",{"date":75,"type":49},"2028-06-30",{"name":5,"class":6}]