- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02048748
Congestive Heart Failure Home Telemonitoring
Congestive Heart Failure Home Telemonitoring : A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
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Tromsø, Norge, 9038
- University Hospital of North Norway
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- the presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association [NYHA] functional class II-IV); and
- ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
Exclusion Criteria:
-
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Kontrollera
Vanlig skötsel
|
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Experimentell: Telemonitoring
Device: Weight and blood pressure device Device: Home telemonitoring device
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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.
An iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
CHF related hospital readmissions
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Length of stay
Tidsram: 12 months
|
Length of stay per hospitalisation
|
12 months
|
Quality of Life MLwHF
Tidsram: 6 months, 12 months
|
6 months, 12 months
|
|
Challenges and opportunities
Tidsram: 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.
|
12 months
|
Additional costs/savings resulting from the service
Tidsram: 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.
|
12 months
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Artur Serrano, PHD, Norwegian Centre for Integrated Care and Telemedicine
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- UNN-NST-TeleCHF-01
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