Clinical trial NCT02860013: Telemedicine for Patients Suffering From Heart Failure (Danish Telecare North Trial)
Official title: Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Telemedicine
Effectiveness
Cost-effectiveness
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mental health related quality of life (SF-36 questionnaire mental scores)
timeFrame: 12 month follow-up
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Changes in daily functioning (KCCQ questionnaire score)
timeFrame: 12 month follow-up
measure: Physical health related quality of life (SF-36 questionnaire Physical scores)
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References:
citation: 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.
citation: Cichosz 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.
citation: Cichosz 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.