Telemedicine for Patients Suffering From Heart Failure (Danish Telecare North Trial) (TCN)
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|ClinicalTrials.gov Identifier: NCT02860013|
Recruitment Status : Unknown
Verified August 2016 by Ole K. Hejlesen, Aalborg University.
Recruitment status was: Not yet recruiting
First Posted : August 9, 2016
Last Update Posted : August 9, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Telemedicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Cost-effectiveness of Telemedicine for Heart Failure: The Danish "TeleCare North" Pragmatic Randomized Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2017|
Active Comparator: Telemedicine
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.
No Intervention: Usual care
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
- 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.
- Changes in daily functioning (KCCQ questionnaire score) [ Time Frame: 12 month follow-up ]Changes in daily functioning measured by KCCQ questionnaire score.
- Physical health related quality of life (SF-36 questionnaire Physical scores) [ Time Frame: 12 month follow-up ]Changes in physical health-related quality of life (SF-36 questionnaire physical score) at baseline to follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860013
|Contact: Ole Hejlesen, Professorfirstname.lastname@example.org|
|Contact: Lars Ehlers, Professoremail@example.com|