We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart Failure Blood Pressure Body Weight Device: Weight and blood pressure device Device: Home telemonitoring device

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Telemonitoring
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
Usual care


Outcome Measures

Primary Outcome Measures :
  1. CHF related hospital readmissions [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: 12 months ]
    Length of stay per hospitalisation

  2. Quality of Life MLwHF [ Time Frame: 6 months, 12 months ]
  3. 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.

  4. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Artur Serrano, PHD +47 966 83 435 artur.serrano@telemed.no

Locations
Norway
University Hospital of North Norway Not yet recruiting
Tromsø, Norway, 9038
Contact: Ragnhild Jonassen, RN         
Sponsors and Collaborators
University Hospital of North Norway
Helse Nord
Investigators
Principal Investigator: Artur Serrano, PHD Norwegian Centre for Integrated Care and Telemedicine
More Information

Additional Information:
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02048748     History of Changes
Other Study ID Numbers: UNN-NST-TeleCHF-01
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014

Keywords provided by University Hospital of North Norway:
Home Care Services
Telemedicine

Additional relevant MeSH terms:
Heart Failure
Body Weight
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms