Weinstein 2019.
Study characteristics | ||
Methods |
Design: individually randomised, open‐label controlled trial Duration: endpoint at 13.04 weeks Setting: recruited from Allergy/Clinical Immunology and Pulmonary departments; trial carried out in the United States |
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Participants |
Population: 39 participants were randomised to use the Asthma Adherence Pathway/AAP Internet Application and an electronic monitoring device/EMD (n = 27) or usual care (n = 23) Age: range from: 23 to 69 years old; mean age in the Asthma Adherence Pathway and EMD group was 41; mean age in usual care was 39 Proportion of male participants: Asthma Adherence Pathway and EMD group was 40% male; usual care was 25% male Asthma severity: moderate to severe asthma Baseline lung function: Asthma Adherence Pathway and EMD group FEV1 = 0.76%; usual care FEV1 = 0.70% Inclusion criteria: suboptimal asthma control (Asthma Control Questionnaire (ACQ) score > 1.0) and prescribed an ICS or an ICS/LABA for at least 1 month before screening Exclusion criteria: intermittent asthma, asthma exacerbation over the past 3 months, serious uncontrolled medical conditions, diagnosis of any other chronic pulmonary disease Percentage withdrawn: 22% Withdrawal from the AAP and EMD group: 19% Withdrawal from usual care: 20% Allowed medication: none recorded Disallowed medication: none recorded |
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Interventions |
Asthma Adherence Pathway and EMD group: intervention patients completed the Asthma Adherence Pathway software and were given barrier‐specific motivational interviewing adherence strategies and a SmartTrackdevice to monitor mometasone furoate/formoterol (MF/F) use (where inhalations were taken twice daily). Clinicians in the interventional group received adherence management training. Interventional patients were given feedback regarding adherence findings at each monthly visit, so interactivity with patients was two‐way. No co‐interventions used. Not a theory‐based intervention. Usual care: usual asthma care |
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Outcomes | Secondary: quality of life | |
Notes |
Type of publication: peer‐reviewed Funding: Merck & Co. COI: AG Weinstein is President of Asthma Management Systems, LLC (Newark, Del). The rest of the authors declare that they have no relevant conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomised in an alternating process to intervention or control group |
Allocation concealment (selection bias) | Unclear risk | No information given on concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding of clinicians and patients to interventions was not possible for this intervention, however the intervention and control group clinicians evaluated participants in different areas of the medical centre and were asked not to discuss study interactions with each other |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Groups were unblinded. Patients in the intervention group were assessed and given MF/F feedback. Adherence performed at follow‐up visits so likely affected behaviour (despite adherence being assessed objectively by EMD). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Baseline data from the dropout groups were not included in the analysis and power was not calculated but loss to follow‐up rates were similar in both groups |
Selective reporting (reporting bias) | Low risk | All data presented specified as per abstract and methods |