Modi 2016a.
Study characteristics | ||
Methods |
Study design: RCT feasibility and acceptability Method of randomisation: stratified block randomisation with type of phone (text‐enabled only vs smart phone) as the blocking variable Setting: Cincinnati Children's Hospital Medical Center Date it was conducted: not reported Source of funding: the Fifth Third Bank/Charlotte R. Schmidlapp Women Scholars Program Conflict of interest: the study authors declare no conflict of interest |
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Participants |
Inclusion/exclusion criteria: patients 13–17 years old, live within 75 miles of the hospital, no chronic medical disorders requiring daily medications, no significant parent‐reported developmental disorders, no liquid AED formulation, and no AED weaning plans in the 3 months following enrolment Sample size: 25 adolescents and caregivers. Not clear form the paper how many participant in each group. Missing data were observed for 4% of the baseline adherence data and 14.6% of the ‘active intervention’ and ‘post‐intervention’ phases Age: 15.7 years (SD 1.5) Gender: 48% were female |
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Interventions |
Type of intervention: behavioural The IGs received reminder text messaging as follows. Group 1: text messaging received by adolescent only; Group 2: text messaging received by adolescent and their caregiver, as well as a single‐family communication session; Group 3: application for the adolescent only; Group 4: application for both the adolescent and caregiver, with the single‐family communication sessions; Group 5: the Epilepsy Tool Kit application created by the National Society for Epilepsy (CG) |
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Outcomes | Adherence, treatment acceptability and feasibility | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified block randomisation with type of phone (text‐enabled only versus smart phone) as the blocking variable was described |
Allocation concealment (selection bias) | Unclear risk | No information on concealment was reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information on blinding was reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding was reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No reporting of attrition/exclusions |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement |
Other bias | Unclear risk | Insufficient rationale or evidence to permit judgement |