Cardiology department Y, Bispebjerg-Frederiksberg Hospital
Frederiksberg, 2000, Denmark
Location status: Recruiting
NCT Number: NCT06176131
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.
Interested in participating?
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Observational
Frederiksberg, 2000, Denmark
Location status: Recruiting
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:
At baseline and at month 6 there will be recorded:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients admitted with acute decompensated heart failure AND:
Exclusion criteria
Telemedicine support from the hospital-based cardiology heart-failure team is provided on demand defined by the needs from Primary Care and from the patient rather than plain guideline-based targets
Time frame: six months
Number of days out of hospital from date of discharge for the index event until the next re-admission with acute decompensated heart failure
Time frame: six months
number of emergency readmissions after discharge from the index readmission, where there have been signs of decompensated heart failure
Time frame: six months
Proportion of guideline-based target medicines for heart failure that patients actually use (based on purchased medicine prescriptions). This includes angiotensin converter enzyme inhibitors(ACEi)/angiotensin receptor blockers (ARB), Betablockers, Mineralocorticoids, Angiotensin Receptor Neprilysin inhibitors (ARNi), Selective Sodium Glucose Co-Transporter-2 inhibitors (SGLT2i), Hydralazine and Nitrates.
Time frame: six months
Progression of heart failure specific patient-reported outcome measures. These include weekly to monthly collected: • Out-of-breath in daily activities • Night orthopnea • Dizziness • Feeling body fluid retention (leg swelling, increased abdominal pressure, increased intake of diuretics • Tiredness • Feeling of general worsening
Time frame: six months
Number of subjects with established palliative care
Contact information is provided by the study sponsor or research team.
Helena DOMINGUEZ, MD,PhD,Prof
CONTACT
Ida Gustafsson, MD, PhD
CONTACT
University Hospital Bispebjerg and Frederiksberg
Other
Implementering af Cardiostafet tværsektoriel Samarbejdsmodel Med Telemedicin for Udsatte Patienter Med Hjertesvigt Som Ikke Kan Deltage i Hjerterehabilitering
Acronym: ADHFQUAL-BFH
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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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