Vasbinder 2016.

Study characteristics
Methods	Design: block randomised, open‐label controlled trial Duration: endpoint at 52 weeks Setting: recruited from 5 outpatient clinics; trial carried out in the Netherlands
Participants	Population: 209 participants were randomised to receive real‐time medication monitoring/RTMM with short message service/SMS reminders (n = 108) or RTMM alone, i.e. without SMS reminders (n = 111) Age: range from: 4 to 11 years old. Mean age in RTMM with SMS reminders group was 7.8 years; SD = 2.2. Mean age in the RTMM alone group was 7.7 years; SD = 2.1. Proportion of male participants: RTMM with SMS reminders group was 58.42% male; the RTMM alone group was 66.67% male Smoking history: RTMM with SMS reminders group ‐ 16.8% current smokers, 24.8% former smokers, 56.9% never smoked, 1.5% unknown; RTMM alone group ‐ 20.8% current smokers, 28.2% former smokers, 49.5% never smoked, 1.4% unknown Inclusion criteria: 4 to 11 years with doctor diagnosed asthma for > 6 months, visited outpatient clinic in the past 12 months, the use of ICS (fluticasone, fluticasone/salmeterol or beclometasone) delivered via pMDI for > 3 months, and having at least one parent/caregiver with a mobile phone Exclusion criteria: eligible patients unresponsive to telephone calls and patient information leaflets Percentage withdrawn: 4.57% Withdrawal from digital intervention group: 6.48% Withdrawal from control group: 2.70% Allowed medication: none recorded Disallowed medication: none recorded
Interventions	RTMM with SMS reminders group: an RTMM device was connected to the pressurised metered‐dose inhaler (pMDI), where the time and date of administered ICS doses were recorded. Data would be immediately sent to the study database via the mobile telephone network. 2 types of digital interventions as “time‐tailored” SMS reminders were also sent to parents and children, if they possessed a mobile phone, when a dose had not been recorded within 15 minutes of the planned time of administration, therefore the digital interactivity was two‐way. This occurred daily for 365 days. No adherence feedback. No co‐interventions used. Not a theory‐based intervention. RTMM alone group: an RTMM device was also used, however there was only 1 type of digital component as there were no SMS reminders with missed doses
Outcomes	Primary: adherence to ICS Secondary: asthma control, frequency of severe asthma exacerbations, asthma‐specific quality of life
Notes	Type of publication: peer‐reviewed Funding: the Netherlands Organization for Health Research and Development; GlaxoSmithKline; Evalan BV COI: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated block randomisation was used per hospital with block size of 16 patients
Allocation concealment (selection bias)	Low risk	At registration at the RTMM software interface, children were automatically assigned to the intervention or control group
Blinding of participants and personnel (performance bias) All outcomes	High risk	Patients unblinded shortly after the start of the study period, when they found out whether they received SMS reminders or not
Blinding of outcome assessment (detection bias) All outcomes	High risk	Participants regularly interviewed by research assistants about outcomes, potential for outcomes to be influenced
Incomplete outcome data (attrition bias) All outcomes	Low risk	Difference in follow‐up between groups was small and power calculation was included
Selective reporting (reporting bias)	High risk	Outcomes for “healthcare use” not reported as per protocol