The Cardio-share Telemedicine Cross-sector Collaboration Model for Managing Vulnerable Patients With Heart Failure

NCT06176131 | Recruiting

• 1 other identifier: WorkZone-23072092
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure，Congestive; Atrial Fibrillation

Keywords

heart failure; atrial fibrillation; acute decompensated heart failure; heart failure with reduced ejection fraction; heart failure with preserved ejection fraction; telemedicine; health inequity; cross-sector health management

Outcome Measures

Primary Outcomes (1)

• Days out-of-hospital

  Number of days out of hospital from date of discharge for the index event until the next re-admission with acute decompensated heart failure

  six months

Secondary Outcomes (3)

• Number of readmissions

  six months

• Quality of care - Medicines

  six months

• Symptom-based quality of care

  six months

Other Outcomes (1)

• Palliative care

  six months

Study Arms (2)

cardio-share

Patients with successful cardio-share model fulfill at least one of the following: 1. A plan for follow-up after discharge established, based on communication with Primary Care (home-care and/or General Practice) before discharge 2. The patient has accessed MinSP-Ass. and received information on heart failure 3. The patient has sent vital measurements and symptoms through MinSP-Ass. to the hospital cardiologist

Other: Telemedicine-based cross-sector collaboration for patient management

Others

All others who fulfill the inclusion criteria but none of the three elements have been successful are the comparative group "Others"

Interventions

Telemedicine-based cross-sector collaboration for patient management OTHER

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

cardio-share

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the University Hospital of Bispebjerg and Frederiksberg and for whom this is their reference hospital for general heart conditions.

You may qualify if:

• Patients admitted with acute decompensated heart failure AND:
• with previous admission with decompensated heart failure in the three-month period prior to the current admission or
• who have two or more admissions in the 6 months prior to the current admission.

You may not qualify if:

• Patients who
• have refused to share their data for health-quality projects
• have already ongoing telemedicine management for heart failure

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Cardiology department Y, Bispebjerg-Frederiksberg Hospital

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Heart Failure; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirsten Wisborg, MD,PhD,DrM

  University Hospital Bispebjerg and Frederiksberg

  STUDY DIRECTOR

Central Study Contacts

Helena DOMINGUEZ, MD,PhD,Prof

CONTACT

004522989343; mdom0002@regionh.dk

Ida Gustafsson, MD, PhD

CONTACT

004521778226; ida.gustafsson@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Associate Professor

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 19, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

DK (1)