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

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.

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