CHF Home Telemonitoring: A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial

NCT02489370 | Unknown

• 1 other identifier: 2013/356/REK nord
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 with chronic heart failure can reduce pressure on resources, particularly for conditions like chronic heart failure, which exert a large burden on health services. These are conclusions of the Cochrane Systematic Review from 2010. 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 the University Hospital of North Norway (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 current 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.

Conditions

Congestive Heart Failure

Keywords

home care; telecare; telehealth; telemonitoring; chronic heart failure; randomized controlled trial; Congestive Heart Failure; telemedicine

Outcome Measures

Primary Outcomes (2)

• Heart failure related hospital readmissions

  Calculated as the proportion of patients readmitted to hospital at least once during the period of follow-up

  Intervention period (6 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

  6 months

Secondary Outcomes (2)

• Length of stay

  6 months

• Assessment of Quality of Life

  At baseline and end of study (6 months)

Study Arms (2)

Telemonitoring (intervention)

EXPERIMENTAL

an intervention arm testing the proposed telemonitoring service and a control arm with the current treatment. Patients assigned to the intervention arm receive a home telemonitoring kit consisting of a tablet, a wireless weight scale and a portable blood pressure meter. The patient is asked to weigh him- or herself every day and the monitoring procedure happens as previously described. In addition a measurement of the blood pressure is also made.

Device: Home telemonitoring

Usual care (control)

NO INTERVENTION

Patients assigned to the control arm receive treatment as usual, consisting of a recommendation to weigh themselves at home, using their own weight scale, and to report by phone to the polyclinic if there is a significant change in weight.

Interventions

Home telemonitoring DEVICE

The intervention consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at the hospital; and monitor the values by a trained nurse at the Heart polyclinic.

Also known as: Telecare, Telehealth

Telemonitoring (intervention)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe psychiatric disturbance diagnosed by DSM-IV-TR criteria. Any disability that may prevent the subject from completing the informed consent form or other study requirements.
• Medication or drug dependency or abuse (except for nicotine). Inability to handle the technological devices included in the study, for some other reason.

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway

Tromsø, Troms, N-9038, Norway

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• J. Artur Serrano, PhD

  Senior Research Scientist, Norwegian Centre for Telemedicine, University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Paal Tande, MD

  Leader Cardiology Department, University Hospital of North Norway

  STUDY DIRECTOR

• Marina Nilsen, Nurse

  Leader Heart Polyclinic, University Hospital of North Norway

  STUDY CHAIR

Central Study Contacts

J. Artur Serrano, PhD

CONTACT

+4796683435; jarturserrano@gmail.com

Ragnhild Jonassen, Nurse

CONTACT

+4777626914; ragnhild.jonassen@unn.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 3, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

NO (1)