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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 [with consumer summary]
Lilholt PH, Witt Udsen F, Ehlers L, Hejlesen OK
BMJ open 2017 May;7(5):e014587
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 = 1,225 (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.
Reproduced with permission from the BMJ Publishing Group.

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