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Tele-monitoring reduces exacerbation of COPD in the context of climate change -- a randomized controlled trial |
Jehn M, Donaldson G, Kiran B, Liebers U, Mueller K, Scherer D, Endlicher W, Witt C |
Environmental Health 2013 Nov 21;12(99):Epub |
clinical trial |
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; 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* |
BACKGROUND: A home based tele-monitoring system was developed to assess the effects of heat stress (days > 25degreeC) on clinical and functional status in patients with chronic obstructive pulmonary disease (COPD). METHODS: Sixty-two COPD patients (GOLD II to IV) were randomized into a tele-monitoring group (TG, n = 32) or control group (CG, n = 30). Tele-monitoring included (1) daily clinical status (COPD Assessment Test-CAT), (2) daily lung function and (3) weekly 6-minute walk test (6MWT). Duration of monitoring lasted a total of nine months (9 M). RESULTS: From June 1st to August 31st 2012, 32 days with heat stress (29.0 +/- 2.5 degree C) were recorded and matched with 32 thermal comfort days (21.0 +/- 2.9 degree C). During heat stress, the TG showed a significant reduction in lung function and exercise capacity (FEV1% predicted 51.1 +/- 7.2 versus 57.7 +/- 5.0%; p < 0.001 and 6MWT performance 452 +/- 85 versus 600 +/- 76 steps; p < 0.001) and increase in CAT scores (19.2 +/- 7.9 versus 16.2 +/- 7.2; p < 0.001). Over summer, significantly fewer TG patients suffered exacerbation of COPD compared to CG patients (3 versus 14; p = 0.006). Over entire 9 M follow-up, the TG group had fewer exacerbations compared to CG (7 versus 22; p = 0.012), shorter cumulative hospital stay (34 versus 97 days) and 43% fewer specialist consultations (24 versus 42; p = 0.04). CONCLUSION: Heat stress affects clinical and functional status in COPD. Tele-monitoring reduces exacerbation frequency and health care utilization during heat stress and other periods of the year. TRIAL REGISTRATION: DRKS-ID DRK00000705.
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