Jan 2007.
Study characteristics | ||
Methods |
Design: parallel, open‐label randomised controlled trial Duration: trial endpoint of 12 weeks Setting: trial conducted in a single paediatric allergy and asthma clinic, in Tainan, Taiwan |
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Participants |
Population: 196 participants were randomised to receive a physician managed online interactive monitoring tool (n = 99) or a traditional clinic‐based patient education programme (n = 97) Age: range from: 6 to 12 years. Mean age in online interactive monitoring tool group was 11 years; SD: 2. Mean age in the traditional clinic‐based patient education programme was 10 years; SD: 3. Proportion of male participants: online interactive tool was 40% male; traditional clinic based patient education programme was 37% male Asthma severity: participants had a mix of mild, moderate and severe asthma Inclusion criteria: participants aged between 6 and 12 years old with a diagnosis of persistent asthma based on the GINA clinical practical guidelines with access to the Internet by their caregivers Exclusion criteria: diagnosis of bronchopulmonary dyplasia or other co‐morbidities with potential to affect the participant's quality of life. Percentage withdrawn: 17.7% withdrew from online interactive monitoring tool group; 26.8% withdrew from the traditional clinic‐based patient education programme Allowed medication: none recorded Disallowed medication: none recorded |
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Interventions |
Intervention: Physician managed online interactive asthma monitoring tool: Blue Angel for Asthma Kids is a single digital intervention comprising of an Internet‐based interactive asthma education and monitoring programme. Children taught how to monitor and measure peak expiratory flow and monitor asthma symptoms. The components of the programme were (1) basic information on the care of an asthmatic child; (2) an electronic diary; (3) action plan for patients; (4) retrieval analysis system to review patient uploaded data on symptom scores and peak expiratory flow variability. Physicians used a support decision system to asses the available data from patient uploads onto the Internet‐based monitoring tool to instruct the patients by email or telephone to either increase, decrease, or continue their usual treatment. Control: Traditional clinic‐based patient education programme: traditional asthma care plan with written instructions for self‐management. No patient interaction. No asthma feedback. No co‐interventions. Not a theory‐based intervention.
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Outcomes |
Primary outcomes: adherence,asthma control Secondary outcomes: PEF, quality of life (children and carers) |
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Notes |
Type of publication: peer‐reviewed Funding: National Science Council. Bureau of Health Promotion, Department of Health, Taiwan COI: none stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised but no detail on how |
Allocation concealment (selection bias) | Unclear risk | "Sealed envelopes containing treatment assignment." This statement does not indicate that envelopes without all safeguards were used. "Following the session, the nurse opened a sealed envelope containing the treatment assignment"; no mention of whether the envelopes were opened consecutively. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Families were told that the purpose of the study was to find out if keeping track of asthma symptoms daily during a 12‐week study period would help them and their physicians manage the child’s asthma better. No direct information on adherence but aware there were two methods of tracking being compared. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label; adherence measured using "therapeutic and diagnostic monitoring". "We defined therapeutic monitoring as outcomes that directly reflect adherence to therapeutic regimens, including controller medication use and test score for dry powder inhaler (DPI) or metered dose inhaler (MDI) with the spacer technique." ACT and asthma quality of life: both self‐report methods PEFR: although objective, variation in measuring technique can reduce accuracy of results. Participants were aware that the purpose of the study was to see if it would help them manage their asthma better ‐ so potential effect of awareness of group allocation of the 2 methods. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 15 participants, 6 from the control group and 9 from the intervention group, were excluded either at the request of the participants themselves or for lack of data due to Internet failure. 93% per cent of the participants (82/88 in the intervention group and 71/76 in the control group) returned for the follow‐up visit at 12 weeks. 7 families who dropped out were unavailable for contact. Similar rates of loss to follow‐up in both groups. |
Selective reporting (reporting bias) | Low risk | All data presented as per methods |