Clinical Trials Logo

Clinical Trial Summary

The goal of this observational study is to explore the potential of implementing a telemedicine-based cross-sector collaboration model to manage patients with frequent admissions with decompensated heart failure. The main question(s) it aims to answer are: - Characterization of conditions that make these patients vulnerable - Description of key-elements that makes possible to manage the patients with the cardio-share model Participants are: - Patients - will be helped to use the available telemedicine tools - General Practitioners - will be offered teleconferences with cardiologists (chat and video) on demand - Community health workers (caregivers at the patient home or in elderly home) - will be guided to assist the patients to use the available telemedicine tools Researchers will compare readmission rates (primary outcome) and quality of life of patients where the cardio-share management model is successfully implemented one year before and after the implementation.


Clinical Trial Description

Consecutive patients admitted from 01.01.2024 to one single site (University Hospital Bispebjerg and Frederiksberg) with acute decompensated heart failure or with atrial fibrillation treated with loop-diuretics will be included in the project if they had one emergency admission with decompensated heart condition within the prior 3 months or two or more within the prior 6 months. During their hospital admission patients will be helped to use the currently available telemedicine tools, which is "Min Sundhedsdplatformen Assistent" (MinSP-Ass.), which is the Danish version of the Care Companion-extension of MyChart application by EPIC, which is the platform used in East Denmark. Help is provided by the nurses in the ward, with assistance by medicine students working on a pay-per-hour basis. The cardio-share model briefly If it is planned or the patient already is receiving home-care assistance (either at home or at an elderly home), the health-care workers will be contacted to ensure that they can assist the patient to use MinSP-Ass. Likewise, the general practice where the patient belongs to, will be contacted to offer teleconsultation support by the hospital-based cardiologist. This support is primarily by written messages, and by teleconferences on demand (from Primary Care) before patient discharge, in both cases using MedCom standards, which is the current cross-sector communication platform in Denmark. Through MinSP-Ass. patients can receive educational material and can report vital measurements and symptoms. The responsibility of the management of the patient relays in the hospital cardiologist who initiates the cardio-share management. A script for a seamless switching of this responsibility between the cardiologist team and Primary Care will be developed and described throughout the project. This will include solving data-sharing across sectors since there are no current solutions easy to use for this purpose. Data collection The electronic medical record will be explored retrospectively to record data at three time-points: After discharge (Baseline), three and six months after admission. At baseline there will be recorded: i) demography data, ii) selected vital measurements and laboratory data and iii) heart medicines. At month three there will be recorded whether there has been at least one readmission and the date of the first readmission and if the patient has had visits in the cardiology ambulatory. At month six there will be recorded whether there have been one or more readmissions and the date of the first readmission if it occurred after month 3. Demography data will be collected according to the following conditions that may render the patient vulnerable: - Speaking Danish language - Cognitive challenges described in the medical record - Need for help from health community workers or relatives for their daily life - Psychiatric disease (ongoing follow-up) - Substance abuse (alcohol or drugs) At baseline and at month 6 there will be recorded: - Selected vital measurements, which include blood pressure, heart rate and weight - Laboratory data, which include hemoglobin, creatinine and pro-Brain Natriuretic Peptide (pro-BNP) - Prescription and use of heart medicines ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06176131
Study type Observational [Patient Registry]
Source University Hospital Bispebjerg and Frederiksberg
Contact Helena DOMINGUEZ, MD,PhD,Prof
Phone 004522989343
Email mdom0002@regionh.dk
Status Recruiting
Phase
Start date January 1, 2024
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A