Heart FailureTCNNCT02860013
Telemedicine for Patients Suffering From Heart Failure (Danish Telecare North Trial)
A study testing Telemedicine in people with Heart Failure, run by Aalborg University at 1 site in Denmark.
Trial summary
There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemedicine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2016to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- All heart failure patients that may benefit from telehealthcare.
- Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4.
- Patients must have a permanent residence and be motivated for using telehealthcare. *Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.
Who cannot join
- Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
- Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.
- Comorbidity is not an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial
There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts.
It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.
- Conditions
- Heart Failure
- Being tested
- Telemedicine
- Keywords
- Telemedicine, Effectiveness, Cost-effectiveness
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineDevice
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Active comparator | A tablet (a Samsung GALAXY TAB 2 (10.1)) that holds information on handling heart failure in general. The device can also collect and transmit relevant disease-specific data, which are indicative of their current state of health, via a Digital Blood Pressure Monitor (Model UA-767, plus BT-C) and a scale. The device can measure four vital signs, which are transferred wirelessly: blood pressure, pulse, and weight. The tablet can be activated and give a sound, when it is time for taking measurements again. Receives: Device: Telemedicine |
| Usual care | No intervention | In Denmark, usual practice for treating, monitoring and caring for patients with heart failure are the responsibility of the patient's general practitioner (treatment and monitoring) and the municipalities (practical help and nursing care). Heart failure patients can make appointments with their general practitioner or practice nurse free of charge in order to get help in managing heart failure. Community based care and practical help varies. As a rule community care comes at regular intervals based on a clinically based estimate of the patients' needs, but the personnel are not necessarily certified nurses and often not fully educated in heart failure and definitely not on call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health related quality of life (SF-36 questionnaire mental scores)
Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up.
Measured: 12 month follow-up
Incremental cost-effectiveness ratio (ICER)
The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up.
Measured: 12 month follow-up
Secondary outcomes (2)
Changes in daily functioning (KCCQ questionnaire score)
Changes in daily functioning measured by KCCQ questionnaire score.
Measured: 12 month follow-up
Physical health related quality of life (SF-36 questionnaire Physical scores)
Changes in physical health-related quality of life (SF-36 questionnaire physical score) at baseline to follow-up.
Measured: 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole K. Hejlesen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860013
- Sponsor's protocol ID
- telecare nord heart failure
- Acronym
- TCN
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2016
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vestergaard AS, Hansen L, Sorensen SS, Jensen MB, Ehlers LH. Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial. BMJ Open. 2020 Jan 27;10(1):e031670. doi: 10.1136/bmjopen-2019-031670.
PubMed 31992604Cichosz SL, Udsen FW, Hejlesen O. The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial. J Telemed Telecare. 2020 Aug-Sep;26(7-8):452-461. doi: 10.1177/1357633X19832713. Epub 2019 Apr 11.
PubMed 30975047Cichosz SL, Ehlers LH, Hejlesen O. Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):590. doi: 10.1186/s13063-016-1722-5.
PubMed 27955682
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT02860013
- Acronym / sponsor ID
- TCN / telecare nord heart failure
- Conditions
- Heart Failure
- Keywords
- Telemedicine, Effectiveness, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts.
It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Active comparator | Device: TelemedicineA tablet (a Samsung GALAXY TAB 2 (10.1)) that holds information on handling heart failure in general. The device can also collect and transmit relevant disease-specific data, which are indicative of their current state of health, via a Digital Blood Pressure Monitor (Model UA-767, plus BT-C) and a scale. The device can measure four vital signs, which are transferred wirelessly: blood pressure, pulse, and weight. The tablet can be activated and give a sound, when it is time for taking measurements again. |
| Usual care | No intervention | –In Denmark, usual practice for treating, monitoring and caring for patients with heart failure are the responsibility of the patient's general practitioner (treatment and monitoring) and the municipalities (practical help and nursing care). Heart failure patients can make appointments with their general practitioner or practice nurse free of charge in order to get help in managing heart failure. Community based care and practical help varies. As a rule community care comes at regular intervals based on a clinically based estimate of the patients' needs, but the personnel are not necessarily certified nurses and often not fully educated in heart failure and definitely not on call |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All heart failure patients that may benefit from telehealthcare.
- Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4.
- Patients must have a permanent residence and be motivated for using telehealthcare. *Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.
Key exclusion criteria (3 listed)
- Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage.
- Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment.
- Comorbidity is not an exclusion criterion.
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 | Device | Telemedicine |
Primary outcome
Mental health related quality of life (SF-36 questionnaire mental scores)
Time frame: 12 month follow-up
Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up.
Incremental cost-effectiveness ratio (ICER)
Time frame: 12 month follow-up
The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up.
2 secondary outcomes
Changes in daily functioning (KCCQ questionnaire score)
Time frame: 12 month follow-up
Physical health related quality of life (SF-36 questionnaire Physical scores)
Time frame: 12 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 31992604Vestergaard AS, Hansen L, Sorensen SS, Jensen MB, Ehlers LH. Is telehealthcare for heart failure patients cost-effective? An economic evaluation alongside the Danish TeleCare North heart failure trial. BMJ Open. 2020 Jan 27;10(1):e031670. doi: 10.1136/bmjopen-2019-031670.
- Derived from this study: PubMed 30975047Cichosz SL, Udsen FW, Hejlesen O. The impact of telehealth care on health-related quality of life of patients with heart failure: Results from the Danish TeleCare North heart failure trial. J Telemed Telecare. 2020 Aug-Sep;26(7-8):452-461. doi: 10.1177/1357633X19832713. Epub 2019 Apr 11.
- Derived from this study: PubMed 27955682Cichosz SL, Ehlers LH, Hejlesen O. Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial. Trials. 2016 Dec 12;17(1):590. doi: 10.1186/s13063-016-1722-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Heart Failure, run by Aalborg University 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: finished, as of the sponsor's last update on 15 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health related quality of life (SF-36 questionnaire mental scores) (time frame: 12 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02860013, which also lists 3 linked publications.
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 15 Aug 2023.