[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06114615":3,"trial-entities:NCT06114615":108,"trial-summary:NCT06114615":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":49,"secondary_outcomes":66,"sex":72,"minimum_age":73,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":80,"locations":84,"central_contacts":100,"overall_officials":105,"references":106,"see_also_links":107},"NCT06114615","1972752","Digital Monitoring for Patients Post Coronary Interventions to Reduce Risk for Recurrent Adverse Cardiovascular Events","RECRUITING","2027-01-01","2026-02","2026-02-23","2024-01-01","University of California, Davis","OTHER",true,"The study aims to support patients immediately after percutaneous coronary intervention (PCI) by implementing a telemonitoring program. Eligible patients have coronary heart disease and undergo PCI. The intervention group receives remote monitoring and text-based follow-up, with established health goals and education on using the telemonitoring application, along with necessary devices. The control group gets standard care. Outcomes measured include blood pressure, LDL levels, patient satisfaction, revascularization, and mortality. The study findings will enhance patient care after PCI and contribute evidence for widespread telemonitoring implementation in healthcare systems, aiding medical therapy and lifestyle modifications.","The study involves 200 participants divided into intervention and control groups, all diagnosed with coronary heart disease and treated with PCI. Upon discharge, the intervention group receives remote monitoring, text messages, and devices for self-management. Control group receives standard care. Recruitment is from cardiology and primary care clinics, with interpreters available. Study coordinator guides device setup during enrollment. Intervention group receives daily messages for a week, then weekly reminders and counseling. Messages are in English or Spanish as per preference. Patient data is collected, including demographics, medications, and outcomes such as blood pressure and readmission rates. Satisfaction is evaluated through surveys and interviews.",[18],"Coronary Artery Disease",[20,21,22],"post-PCI","digital monitoring","cardiac rehabilitation","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},200,"ESTIMATED",[31,39,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DEVICE","LiveCare","Patient use LiveCare device to monitor their blood pressure and data is transmitted to dashboard.",[36],"Discharged with LiveCare and Text Message Intervention",[38],"Blood Pressure and Weight Monitoring",{"type":40,"name":41,"description":42,"armGroupLabels":43},"BEHAVIORAL","Text Messages","Patients also receive text messages after their PCI procedure for follow up appointment reminders, enrollment in cardiac rehab, and diet and exercise counseling.",[36],{"type":13,"name":45,"description":46,"armGroupLabels":47},"Conventional Care","No digital monitoring with LiveCare device and no text messages.",[48],"Discharged with Conventional Care",[50,53,55,57,59,63],{"measure":51,"timeFrame":52},"blood pressure, systolic and diastolic","1 month, 6 months",{"measure":54,"timeFrame":52},"readmission rate",{"measure":56,"timeFrame":52},"enrollment rate in cardiac rehabilitation",{"measure":58,"timeFrame":52},"rate of non-compliance to medications prescribed at discharge",{"measure":60,"description":61,"timeFrame":62},"average ratings on the telehealth usability questionnaire","assess patient satisfaction with the teleheath program with 12 questions, each 1-7 points. Total of 84 points; higher score indicates greater satisfaction","six months",{"measure":64,"timeFrame":65},"patient rate of first follow up appointment","1 month, 6 month",[67,70],{"measure":68,"timeFrame":69},"lipid profile","one month, six months",{"measure":71,"timeFrame":69},"Major adverse cardiovascular events (MACE)","ALL",null,false,{"inclusion":76,"exclusion":78,"raw_text":79},[77],"Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.",[],"Inclusion Criteria:\n\n* Includes patients with coronary heart disease diagnosis and treatment with PCI who follow up at University of California Davis Health.",[81,82,83],"CHILD","ADULT","OLDER_ADULT",[85],{"facility":86,"status":7,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":97},"University of California, Davis Medical Center Division of Cardiovascular Medicine","Sacramento","California","95817","United States",[92],{"name":93,"role":94,"phone":95,"email":96},"Surabhi Atreja, MD","CONTACT","916-734-6082","smatreja@ucdavis.edu",{"lat":98,"lon":99},38.58157,-121.4944,[101,103],{"name":93,"role":94,"phone":102,"email":96},"(916) 734-2011",{"name":104,"role":94},"Lina Du, BS",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":110},[18],[],{"nct_id":4,"found":14,"summary":112,"prompt_version":73},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This interventional study plans to enroll 200 participants with coronary heart disease who have undergone PCI. Participants will be divided into an intervention group receiving digital monitoring and text messages, and a control group receiving standard care.","completed","Digital Monitoring After Coronary Interventions","This study is testing if digital monitoring and text messages can help patients after a percutaneous coronary intervention (PCI), a procedure to open blocked heart arteries. You would be eligible if you have coronary heart disease and have had a PCI at UC Davis Health. The study compares two groups: one uses a LiveCare device to monitor blood pressure and receives text messages for reminders and health advice, while the other receives standard care. Researchers will look at your blood pressure, how often you are readmitted to the hospital, and how many people join cardiac rehabilitation (a program to help your heart recover). The study aims to enroll 200 participants, but its current status is unclear.","Blood pressure and readmission rates will be measured at 1 month and 6 months after the intervention.",116,"Participants in the intervention group will use a LiveCare device to monitor blood pressure and receive daily text messages for one week, then weekly messages. The study coordinator will help with device setup.","Not stated in the trial record.",[33,41]]