Tabak 2013.
| Methods |
Location: Twente, Netherlands Design: randomised controlled trial Unit of allocation: individual Start date: October 2010 End date: April 2011 Duration of intervention: 4 weeks Time points measured: baseline, end of week 1, follow‐up measurement end of weeks 2, 3, 4 |
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| Participants |
Population description: participants with a clinical diagnosis of COPD and no infection/exacerbation for 4 weeks before measurement. All were current/former smokers, had Internet access, and could read/speak Dutch. Participants were excluded if they had impaired hand function causing inability to use the application or any illness that influenced daily activities, other respiratory diseases, needed regular oxygen therapy, and received training with a physiotherapist during the 6 weeks before starting the study Setting: own home Method of recruitment: recruited by chest physician or nurse practitioner Participants: 30 (14 to intervention group and 16 to control group) Age: average 66 years |
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| Interventions | Intervention is an app comprising 2 modules • Activity coach • Web portal for recording symptoms and activity levels Daily completion of the diary on the Web portal triggered a decision support system in cases of exacerbation. The activity coach consisted of a 3‐D accelerometer and smart phone with bluetooth. Both were worn by the participant |
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| Outcomes | Self‐reported health status using the CCQ and mean activity level (pedometer) | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Eligible participants were randomly assigned to intervention or control group according to a computer‐generated randomisation list (programme: Block Stratified Randomization V5: Steven Piantadosi) whereby blocked randomisation was applied in blocks of 4, stratified for gender (p 3) |
| Allocation concealment (selection bias) | Low risk | Participants and investigators enrolling participants could not foresee assignment because allocation to groups was conducted by a different person from the one who conducted the randomisation, recruited participants, and collected data (p 3) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible; therefore, although potentially limited as all study activity was online, participants may have been influenced by prior beliefs about whether or not the intervention is likely to work. Allocation procedure not described (p 3) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding of outcome assessment occurred; therefore, participants may have given what was perceived as the 'right' response (p 3) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All data accounted for in Figure 1 (p 5). One participant in the intervention group was lost to follow‐up owing to technical problems. No participants were lost from the control group |
| Selective reporting (reporting bias) | Low risk | Data on all outcomes, at all collection points, between groups, and within groups were reported (Tables 2, 3, 4) (p 6) |
| Other bias | Low risk | Study appears to be free from other sources of bias |