Mobile App Plus Standard Care Shows Mixed Results for Asthma Control in Malaysian Adults
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Key Takeaway
Interpret mixed RCT evidence for a mobile asthma app with caution due to conflicting complete-case and ITT analyses.
A 6-month randomized controlled trial at Hospital Pulau Pinang, Malaysia, enrolled 162 adult outpatients with physician-diagnosed asthma. Participants were assigned to receive either the CareAide® mobile application plus standard care or standard care alone, with asthma control measured by the ACQ-7 questionnaire at 6 months.
In the primary analysis of 129 patients who completed follow-up (complete cases), the intervention group had a mean ACQ-7 score of 0.99 compared to 1.34 in the control group. The adjusted mean difference was -0.414 (95% CI -0.783 to -0.045; p = 0.028), indicating a statistically significant improvement in asthma control favoring the mobile app group. However, an intention-to-treat sensitivity analysis using multiple imputation for all 162 randomized patients showed a non-significant adjusted mean difference of -0.350 (95% CI -0.780 to 0.081; p = 0.110).
Safety and tolerability data were not reported. A notable limitation is that 33 patients (20% of the randomized sample) did not complete the 6-month follow-up, potentially affecting the completeness of the primary analysis. Funding sources and conflicts of interest were also not reported.
For practice, this study provides preliminary but mixed evidence regarding the effectiveness of a specific mobile application as an adjunct to standard asthma care. The discrepancy between the complete case and intention-to-treat analyses suggests the findings may be sensitive to missing data. Clinicians should interpret these results cautiously, recognizing that the intervention showed a signal of benefit in one analysis but not in another more conservative analysis.
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View Original Abstract ↓
INTRODUCTION: Asthma affects over 260 million globally, with poor control and non-adherence limiting outcomes. Malaysia reports 6.2% adult prevalence, necessitating innovative strategies. Mobile health (mHealth) apps show promise for enhancing engagement and self-management in chronic respiratory diseases.
OBJECTIVE: To evaluate the effectiveness of the CareAide® mobile application in improving asthma control among Malaysian adults.
METHODOLOGY: An open-label, randomised controlled trial was conducted at Hospital Pulau Pinang between July 2023 and June 2024. 162 adults with physician-diagnosed asthma were randomised to intervention (CareAide® plus standard care) or control (standard care). The Primary outcome (6-month asthma control via Asthma Control Questionnaire ACQ-7) was analyzed using ANCOVA (complete cases), and ITT sensitivity via multiple imputation was performed as secondary analysis.
RESULTS: Among 162 randomised patients, 129 completed 6-month follow-up (intervention n = 68, control n = 61). Participants were predominantly female (66%), middle-aged (40-59 years), and living in urban areas (92%). Baseline asthma control was similar between groups (ACQ-7: 1.73 (1.08) in the intervention group vs 1.51 (0.95) in the control group. At 6 months, mean ACQ-7 scores were 0.99 (intervention) and 1.34 (control), corresponding to an adjusted mean difference of -0.414 (95% CI -0.783 to -0.045; p = 0.028) in favour of the intervention after baseline adjustment. An intention-to-treat sensitivity analysis using multiple imputation (N = 162) showed a similar direction of effect (adjusted mean difference -0.350; 95% CI -0.780 to 0.081; p = 0.110).
CONCLUSION: CareAide® significantly improved asthma control as an effective digital adjunct for chronic respiratory management.
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