Lv 2019.
Study characteristics | ||
Methods |
Design: parallel, individually randomised controlled trial Duration: endpoint at 52 weeks Setting: recruited from primary and secondary setting: 2 tertiary hospitals (secondary), and 2 community healthcare centres (primary); trial carried out in China |
|
Participants |
Population: 152 children were randomised to receive mobile application (n = 77) or nurse‐led group (n = 75) Age: range from 6 to 12 years. Mean age in mobile application group was 7.8 years; SD: 1.4. Mean age in nurse‐led group was 8.1 years; SD: 1.4. Proportion of male participants: mobile application group was 53.2% male; nurse‐led group was 46.7% male Proportion of white ethnic participants: 0% white Asthma severity: mixed Inclusion criteria: age between 6 and 12 years; medical history, symptoms and signs consistent with the diagnosis of asthma; positive asthma predictive index; willingness and ability to correctly use an inhaler; possession of a smartphone and ability to use the mobile application; ability to correctly use the Childhood Asthma Control Test (C‐ACT) Exclusion criteria: severe asthma exacerbation at the time of enrollment; currently suffering from the concurrent acute or chronic rhinosinusitis, obstructive sleep apnoea, or rheumatic diseases; co‐morbidities including bronchopulmonary dysplasia, bronchiectasis, tracheal or bronchial malacia, obliterative bronchiolitis, diffuse panbronchiolitis or tuberculosis; and diagnosed primary immunodeficiency Percentage withdrawn: Withdrawal from mobile application group was 9.09%; withdrawal from nurse‐led group was 2.67% Allowed medication: received fluticasone propionate inhaled aerosol. For those who required long‐term ICS + LABA, salmeterol‐fluticasone dry powder was prescribed (so just routine controller medications). Disallowed medication: none recorded |
|
Interventions |
Mobile application + nurse‐led group: the mobile application included modules on medication reminders, adherence management, alert of acute asthma exacerbations, assessment of exacerbation severity, treatment recommendation, keeping a health diary, instant communication with healthcare providers and health education. One‐way interaction with patient. There were 12 intervention sessions; monthly reviews.Two weeks after each visit, nurse would call parents to review treatment adherence. No co‐interventions used (one digital component). Not a theory‐based intervention. In‐person component involved: the nurse. Nurse‐led group: nurse‐led asthma management. There were 12 intervention sessions; monthly reviews. Two weeks after each visit, the nurse would call parents to review treatment adherence. |
|
Outcomes |
Primary: asthma exacerbations Secondary: treatment adherence, C‐ACT scores, number of respiratory infections, days of antibiotic use, requirements for oral steroid intake, days of school absence, days of parental work loss and medical expenses |
|
Notes |
Type of publication: peer‐reviewed Funding: Science and Technology Research Project of Jinhua, the Natural Science Foundation of China and Zhejiang Provincial Natural Science Foundation Grant COI: none |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Randomisation through a random number table, with odd numbers assigned to experimental group and even numbers assigned to control group |
Allocation concealment (selection bias) | Unclear risk | No allocation concealment noted |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Healthcare providers informed every participant in the experimental group the exact information the application would collect from their mobile phone. However, participants from both groups did not know how the information would be used. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding described; unclear if knew allocation and this could affect outcome. Patient measured adherence through (total number of days taking ICS over a year/365) x 100. Did not explain how they measured it; however, most children received a fluticasone propionate aerosol. Those requiring a longer‐term therapy with ICS + LABA, a salmeterol + fluticasone DPI was prescribed. Consequently, we can speculate that dose counts were used. But this is unclear. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Below powered sample; higher rate of dropout in intervention group. This can skew data to favour control group data. |
Selective reporting (reporting bias) | Low risk | Results specified as per methods |