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.
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