Clinical trial NCT02048748: Congestive Heart Failure Home Telemonitoring
Official title: Congestive Heart Failure Home Telemonitoring : A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Blood Pressure
Body Weight
Keywords: Home Care Services
Telemedicine
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: Helse Nord
First posted: 2014-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may provide benefits on health care costs and quality of life. Currently there is limited use of remote monitoring for heart failure in Norway. The funding streams and the structure of the norwegian health service is different from other countries that have tried remote monitoring and therefore it is important to examine the utility of such services in Norway. The study is a randomised controlled trial that will allow participants in the intervention group to use a wireless weight scale and blood pressure monitor device that will send automatically the measurements electronically and securely to the Heart Failure Outpatient Clinic of the hospital.

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: CHF related hospital readmissions
timeFrame: 12 months
Secondary outcomes:
measure: Length of stay
timeFrame: 12 months
measure: Quality of Life MLwHF
timeFrame: 6 months, 12 months
measure: Challenges and opportunities
timeFrame: 12 months
measure: Additional costs/savings resulting from the service
timeFrame: 12 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: Norwegian Centre for Integrated Care and Telemedicine
name: Artur Serrano, PHD
role: PRINCIPAL_INVESTIGATOR
References: