Congestive Heart Failure Home Telemonitoring
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02048748|
Recruitment Status : Unknown
Verified January 2014 by University Hospital of North Norway.
Recruitment status was: Not yet recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
|Condition or disease||Intervention/treatment|
|Heart Failure Blood Pressure Body Weight||Device: Weight and blood pressure device Device: Home telemonitoring device|
Providing patients with chronic heart failure (CHF) access to remote monitoring, for example by telephone or telemonitoring using wireless technology, reduces deaths and hospitalisations and may provide benefits on health care costs and quality of life. Remote monitoring of patients can reduce pressure on resources, particularly for conditions like chronic heart failure, which exert a large burden on health services. These are conclusions of a Cochrane Systematic Review.
In Norway the costs for treatment of chronic heart failure are vast, both concerning hospital treatment, daily use of medication over years, and loss of quality of life for patients and their family caregivers. Generally there is little knowledge about what is gained for the billions used. In Norway no telemonitoring services are established and hence no investigations have yet been published. Thus it seems that current evidence of effectiveness and quality is insufficient to recommend usage. The structure and funding streams in Norwegian health services are different from other countries and the conventional services that the intervention has been compared to in previous studies, are most likely heterogeneous. It is thus important to investigate Norwegian conditions.
Advanced telemonitoring technology with electronic transfer of physiological data such as blood pressure and weight is currently being used in research and established routine services in several countries in Europe, amongst them the Netherlands, Germany and the United Kingdom.
The proposed project intends to introduce such a strategy as an avenue for exploring promising new services that would not otherwise be available in Norway. The service consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at UNN; and monitor the values by a trained nurse at the Heart polyclinic.
The primary objective of this study is thus to explore whether, as compared to current care from the heart polyclinic, the introduction of home telemonitoring will reduce hospital readmissions and will, in addition, be cost-effective. This is in line with the recent directions of European telemonitoring programmes for patients with chronic heart failure. This result may define if the telemonitoring of heart failure patients is feasible for Norway or not at all.
Identifying successful innovations to be introduced into the Norwegian health care services is a condition for more cost effectiveness and better treatment quality.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Congestive Heart Failure Home Telemonitoring : A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||January 2015|
Device: Weight and blood pressure device Device: Home telemonitoring device
Device: Weight and blood pressure device
Weight and blood pressure device integrated in a home telemonitoring kit. The weight scale is Withings The Smart Bodyscale. The blood pressure device is MEDISANA iHealth BP3.Device: Home telemonitoring device
An iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit.
No Intervention: Control
- CHF related hospital readmissions [ Time Frame: 12 months ]
- Length of stay [ Time Frame: 12 months ]Length of stay per hospitalisation
- Quality of Life MLwHF [ Time Frame: 6 months, 12 months ]
- Challenges and opportunities [ Time Frame: 12 months ]Qualitative analysis of conditions for identified best practices resulting from the intervention, and possible to be developed. Interview with patients and health professionals. Thematic analysis of transcribed interviews. Identification of themes related to best practices and challenges.
- Additional costs/savings resulting from the service [ Time Frame: 12 months ]Additional costs/savings resulting from the service defined as the difference in the costs of medical care during the study, identified through a cost analysis, between the intervention and control arms.
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): NCT02048748
|Contact: Artur Serrano, PHD||+47 966 83 firstname.lastname@example.org|
|University Hospital of North Norway||Not yet recruiting|
|Tromsø, Norway, 9038|
|Contact: Ragnhild Jonassen, RN|
|Principal Investigator:||Artur Serrano, PHD||Norwegian Centre for Integrated Care and Telemedicine|