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Open Access Study protocol

Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial

Flemming Witt Udsen1*, Pernille Heyckendorff Lilholt2, Ole Hejlesen2 and Lars Holger Ehlers1

Author Affiliations

1 Danish Centre for Healthcare Improvements, Aalborg University, Fibigerstraede 11, 9220 Aalborg Ø, Denmark

2 Department of Health Science and Technology, Aalborg University, Fredrik Bajers Vej 7, C1-211, 9220 Aalborg Ø, Denmark

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Trials 2014, 15:178  doi:10.1186/1745-6215-15-178

Published: 21 May 2014

Abstract

Background

Several feasibility studies show promising results of telehealthcare on health outcomes and health-related quality of life for patients suffering from chronic obstructive pulmonary disease, and some of these studies show that telehealthcare may even lower healthcare costs. However, the only large-scale trial we have so far - the Whole System Demonstrator Project in England - has raised doubts about these results since it conclude that telehealthcare as a supplement to usual care is not likely to be cost-effective compared with usual care alone.

Methods/Design

The present study is known as ‘TeleCare North’ in Denmark. It seeks to address these doubts by implementing a large-scale, pragmatic, cluster-randomized trial with nested economic evaluation. The purpose of the study is to assess the effectiveness and the cost-effectiveness of a telehealth solution for patients suffering from chronic obstructive pulmonary disease compared to usual practice. General practitioners will be responsible for recruiting eligible participants (1,200 participants are expected) for the trial in the geographical area of the North Denmark Region. Twenty-six municipality districts in the region define the randomization clusters. The primary outcomes are changes in health-related quality of life, and the incremental cost-effectiveness ratio measured from baseline to follow-up at 12 months. Secondary outcomes are changes in mortality and physiological indicators (diastolic and systolic blood pressure, pulse, oxygen saturation, and weight).

Discussion

There has been a call for large-scale clinical trials with rigorous cost-effectiveness assessments in telehealthcare research. This study is meant to improve the international evidence base for the effectiveness and cost-effectiveness of telehealthcare to patients suffering from chronic obstructive pulmonary disease by implementing a large-scale pragmatic cluster-randomized clinical trial.

Trial registration

Clinicaltrials.gov, http://NCT01984840 webcite, November 14, 2013.

Keywords:
Chronic obstructive pulmonary disease; Telemedicine; Cluster randomized trial; Effectiveness; Cost-effectiveness; Denmark