Heart Failure，CongestiveADHFQUAL-BFHNCT06176131
The Cardio-share Telemedicine Cross-sector Collaboration Model for Managing Vulnerable Patients With Heart Failure
An observational study of Heart Failure，Congestive and Atrial Fibrillation, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure，Congestive, Atrial Fibrillation
- What is being tested?
- Telemedicine-based cross-sector collaboration for patient management
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the University Hospital of Bispebjerg and Frederiksberg and for whom this is their reference hospital for general heart conditions.
Who may be able to join
- 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.
Who cannot join
- Patients who
- have refused to share their data for health-quality projects
- have already ongoing telemedicine management for heart failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Cardiology department Y, Bispebjerg-Frederiksberg Hospital
Frederiksberg, 2000
Helena Dominguez, MD, PhD, +4538163916 ext. 6068, mdom0002@regionh.dk
Christoffer V Madsen, MD, +4520661178, cmad0140@regionh.dk
About this study
Official title: Implementering af Cardiostafet tværsektoriel Samarbejdsmodel Med Telemedicin for Udsatte Patienter Med Hjertesvigt Som Ikke Kan Deltage i Hjerterehabilitering
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
Read more
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.
Read the detailed 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
- Conditions
- Heart Failure，Congestive, Atrial Fibrillation
- Being tested
- Telemedicine-based cross-sector collaboration for patient management
- 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
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-based cross-sector collaboration for patient managementOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six months
Secondary outcomes (3)
Number of readmissions
number of emergency readmissions after discharge from the index readmission, where there have been signs of decompensated heart failure
Measured: six months
Quality of care - Medicines
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.
Measured: six months
Symptom-based quality of care
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
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure，CongestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena DOMINGUEZ, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Kirsten Wisborg, MD,PhD,DrM, Study director, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176131
- Sponsor's protocol ID
- WorkZone-23072092
- Acronym
- ADHFQUAL-BFH
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2023
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementering af Cardiostafet tværsektoriel Samarbejdsmodel Med Telemedicin for Udsatte Patienter Med Hjertesvigt Som Ikke Kan Deltage i Hjerterehabilitering
- ClinicalTrials.gov ID
- NCT06176131
- Acronym / sponsor ID
- ADHFQUAL-BFH / WorkZone-23072092
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cardio-share | – | Other: Telemedicine-based cross-sector collaboration for patient managementPatients 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 |
| Others | – | –All others who fulfill the inclusion criteria but none of the three elements have been successful are the comparative group "Others" |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the University Hospital of Bispebjerg and Frederiksberg and for whom this is their reference hospital for general heart conditions.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-based cross-sector collaboration for patient managementTelemedicine 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 | Other | cardio-share |
Primary outcome
Days out-of-hospital
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
3 secondary outcomes
Number of readmissions
Time frame: six months
Quality of care - Medicines
Time frame: six months
Symptom-based quality of care
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsten Wisborg, MD,PhD,DrM study director
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure，Congestive and Atrial Fibrillation, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helena DOMINGUEZ, MD,PhD,Prof (004522989343, mdom0002@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days out-of-hospital (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.