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. 2022 Jun 13;2022(6):CD013030. doi: 10.1002/14651858.CD013030.pub2

Joseph 2018.

Study characteristics
Methods Design: parallel, single‐blinded randomised controlled trial
Duration: endpoint at 52 weeks
Setting: recruited from secondary setting; ED at 2 healthcare systems (Henry Ford Health System and Children's Hospital of Michigan at the Detroit Medical Centre); trial carried out in the United States
Participants Population: 121 participants were randomised to receive website application (n = 65) or standard care (n = 56)
Age: range from 13 to 19 years old; mean age was 15.4 years; SD: 1.7
Proportion of male participants: 44.6% male
Proportion of white ethnic participants: 3.3% white
Asthma severity: mixed
Smoking history: mixed
Inclusion criteria: 13 to 19 years of age; those who were under 18 had to be accompanied by legal guardian who provided written informed consent from both teen and guardian; physician diagnosis of acute asthma
Exclusion criteria: previously participated in the school‐based version of Puff City; English was not preferred language
Percentage withdrawn: 0
Allowed medication: none recorded
Disallowed medication: none recorded
Interventions Website application group:
Standard care + online, computer‐tailored asthma management intervention. The app had behavioural assessments on the 4 education sessions on asthma management, e.g. psychosocial issues (smoking, depression, perceived emotional support, and lack of insurance/primary care physician), controller medication adherence, keeping a rescue inhaler nearby, and smoking reduction/cessation.
Behavioural assessments at each of 4 sessions (no less than 1 week apart; within 90 days). Follow‐up at 6 months and 12 months. One‐way interaction with patient. No adherence feedback. No co‐interventions (one digital component). This was theory‐based intervention: behaviour change relevant to asthma control (e.g. Health Belief Model, Attribution Theory, Motivational Interviewing); one of the main theories includes the Transtheoretical Model (TTM), which describes the cognitive and behavioural processes that individuals undergo in relation to changing behaviour ‐ people will not exhibit behavior change without application of strategies more intense than usual.
Standard care group: standard care + access to existing asthma informational websites that were non‐tailored and provide generic asthma education. Follow‐up at 6 months and 12 months.
Outcomes Primary: ED visits
Secondary: ACT scores, number of symptoms days/week, school days missed, school or work days missed, ASRDI (Adolescent Self‐Regulatory Inventory) at 12 months, treatment adherence, using rescue inhaler
Notes Type of publication: peer‐reviewed
Funding: National Institutes of Health, National Heart, Lung, and Blood Institute Grant
COI: none
Contact: no attempt made to contact study authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Online randomisation to the treatment (Puff City) or control group (generic, online asthma education) occurred when participants logged in for session 1 of the intervention/control program
Allocation concealment (selection bias) Low risk Computer randomisation leads to concealment; study personnel were blinded to treatment assignment
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk The ED and research staff were blinded to the treatment assignment, but the participant and caregiver were unblinded at the time, and after, the patient was randomised into the trial. During follow‐up and retention efforts, the research staff remained blinded to the patient group assignment.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Investigators remained blind to allocation until final data set ‐ however adherence data were self‐reported by the online session surveys. It is not known whether the participants knew that adherence was a study outcome of interest.
Incomplete outcome data (attrition bias)
All outcomes High risk No information given on dropouts however from Table 2 ‐ study compliance, at all time points there were higher % compliance with the treatment vs control group with more patients staying with the intervention than control group. These patients may be highly motivated to stay and therefore also report better adherence.
Selective reporting (reporting bias) High risk Methods stated secondary outcome would include "quality of life" but not reported in results