Ringbaek 2015.
Study characteristics | ||
Methods |
Study design: multi‐centre, open‐label, parallel block randomised controlled trial in Denmark Duration: 26 weeks Setting: respirator outpatient clinics |
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Participants |
Population: 281 adults recruited from pulmonary wards at 4 hospitals: Hvidovre, Bispedjerg, Herlev, Amager Hospitals Baseline characteristics: % Male: 39 TM and 55 UC, Mean age: 69.8 TM and 69.4 UC, % White: not reported, % African: not reported, % LTOT: 26 TM and 27 UC, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: Oral prednisone (8.5%), Roflumilast (4.6%), ICS (91%), LAMA (89%), LABA (96%), FEV₁ (% mean): TM 34.9 and UC 33.8, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): TM 35 and UC 47, GOLD stage: severe and very severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: TM 0.91 (0 to 7) and UC 1.22 (0 to 23) Inclusion criteria: stable severe to very severe COPD as measured by GOLD, at high risk of exacerbations and hospitalisations, FEV₁ < 0.7, post‐bronchodilator FEV₁ < 60% predicted, hospitalisation in last 3 years due to exacerbation, LTOT for at least 3 months, regular respiratory outpatient clinic visits, COPD as main cause of disability, living in 1 of 6 municipalities of Copenhagen, living within area of recruiting hospital Exclusion criteria: COPD exacerbation 3 weeks before trial, not giving informed consent, unable to use tablet computer, not able to participate/living outside catchment area 2 weeks or more during study period, language barrier or cognitive disorder, no telephone line |
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Interventions | Measurements taken at baseline and at 6‐month follow‐up Treatment arms
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Outcomes |
Primary outcomes: health‐related QOL by 15D questionnaire Secondary outcomes: CAT |
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Notes |
Funding: not reported Other identifier: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "1:1 allocation using randomised blocks of four (via numbered envelopes) for 6 months" |
Allocation concealment (selection bias) | Low risk | "1:1 allocation using randomised blocks of four (via numbered envelopes) for 6 months" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | It would not be possible to blind patients in the telehealth care arm to treatment, nor people who are administering the intervention due to the nature of the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear whether outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar numbers of deaths were observed in both treatment arms (8 vs 9). Two people in the intervention arm withdrew for technical reasons (although the technical reasons are not explained further). Similar attrition overall in both treatment groups |
Selective reporting (reporting bias) | Unclear risk | No protocol was registered; it is not clear whether outcomes were reported as planned |
Other bias | Low risk | There was good compliance with the TM intervention: "100 (82.6%) patients participated in at least six consultations" |