Pool 2017.
| Study characteristics | ||
| Methods |
Design: parallel, single‐blinded, individually randomised controlled trial Duration: endpoint at 52 weeks Setting: recruited from enrolled insurance plan; trial carried out in the USA |
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| Participants |
Population: 408 participants were randomised to have received online tools designed to prompt users to ask questions related to asthma (n = 203) or active control tool group (n = 204) Age: mean age in intervention group was 47.6; SD 9.1. Mean age in control group was 47.2; SD 9.6. Proportion of male participants: intervention group was 36.4% male; active control group was 37.7% male Proportion of white ethnic participants: intervention group was 81.7% white; active control group was 86.8% white Smoking history: 3.2% smokers (3.5% in intervention group, 2.9% in active control group), 27.1% smoke ≥ 100 cigarettes in lifetime (25.1% in intervention group, 29.1% in active control group) Inclusion criteria: age 21 to 60 years, diagnosed with asthma using HEDIS (Healthcare Effectiveness Data and Information Set) criteria for persistent asthma, medication specific to asthma, emergency room and outpatient visits Exclusion criteria: no asthma diagnosis from a healthcare provider, not able to read/speak English fluently, no Internet access at home, confirmed pregnancy, smoking > 20 pack‐years Percentage withdrawn: withdrawal from intervention group was 22.66%; withdrawal from active control group was 18.63% |
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| Interventions |
Intervention group: online tool items designed to prompt users to ask questions related to asthma, e.g. tests from healthcare providers and encouragement of specific self‐management behaviours via website. There were 12 intervention sessions. Feedback is not specifically adherence but identifies overuse of rescue medication and feedback that ICS is recommended. Two‐way interactivity with patients. Non‐theory‐based intervention. Control group: active control; online tool items designed to prompt users to ask questions not related to asthma (e.g. cancer screening) from healthcare providers. Two‐way interactivity with patients. |
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| Outcomes | ACT, quality of life, medication use, healthcare utilisation | |
| Notes |
Type of publication: peer‐reviewed Funding: National Heart, Lung and Blood Institute R01HL088590 and National Institutes of Health and National Center for Advancing Translational Science, NIH UL1RR033184 COI: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
| Allocation concealment (selection bias) | Low risk | Participants were blinded to their assignment and allocated via the software |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All participants engaged in online tool and were unaware of subject matter (asthma vs non‐asthma) differences in content of messages |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | All contact via online tool so potential for detection of randomisation outcome appears to be low; feedback is automatically generated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition not unusually high and balanced between groups |
| Selective reporting (reporting bias) | High risk | Authors planned to collected QOL measures ‐ mentioned in abstract and paper as secondary outcome but reported as part of asthma control measures not quality of life |