Telehealthcare for patients suffering from chronic obstructive pulmonary disease: effects on health-related quality of life: results from the Danish 'TeleCare North' cluster-randomised trial

Pernille Heyckendorff Lilholt, Flemming Witt Udsen, Lars Ehlers, Ole K Hejlesen, Pernille Heyckendorff Lilholt, Flemming Witt Udsen, Lars Ehlers, Ole K Hejlesen

Abstract

Objective: To assess the effect of telehealthcare compared with usual practice in patients with chronic obstructive pulmonary disease (COPD).

Design: A cluster-randomised trial with 26 municipal districts that were randomly assigned either to an intervention group whose members received telehealthcare in addition to usual practice or to a control group whose members received usual practice only (13 districts in each arm).

Setting: Twenty-six municipal districts in the North Denmark Region of Denmark.

Participants: Patients who fulfilled the Global Initiative for COPD guidelines and one of the following criteria: COPD Assessment Test score ≥10; or Medical Research Dyspnoea Council Scale ≥3; or Modified Medical Research Dyspnoea Council Scale ≥2; or ≥2 exacerbations during the past 12 months.

Main outcome measures: Health-related quality of life (HRQoL) assessed by the physical component summary (PCS) and mental component summary (MCS) scores of the Short Form 36-Item Health Survey, Version 2. Data were collected at baseline and at 12 month follow-up and analysed according to the intention-to-treat principle with complete cases, n=574 (258 interventions; 316 controls) and imputed data, n=1225 (578 interventions, 647 controls) using multilevel modelling.

Results: In the intention-to-treat analysis (n=1225), the raw mean difference in PCS from baseline to 12 month follow-up was -2.6 (SD 12.4) in the telehealthcare group and -2.8 (SD 11.9) in the usual practice group. The raw mean difference in MCS scores in the same period was -4.7 (SD 16.5) and -5.3 (SD 15.5) for telehealthcare and usual practice, respectively. The adjusted mean difference in PCS and MCS between groups at 12 months was 0.1 (95% CI -1.4 to 1.7) and 0.4 (95% CI -1.7 to 2.4), respectively.

Conclusions: The overall sample and all subgroups demonstrated no statistically significant differences in HRQoL between telehealthcare and usual practice.

Trial registration number: NCT01984840; Results.

Keywords: COPD; Denmark; RCT; effectiveness; outcome Assessment (Health Care); quality of life; telehealth; telemedicine; telemonitoring.

Conflict of interest statement

Competing interests: None delared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
The Telekit system consists of a tablet, a blood pressure monitor, a fingertip pulse oximeter and a health precision scale.
Figure 2
Figure 2
CONSORT diagram of the TeleCare North trial.

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