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Mobile health apps improve Health-Related Quality of Life in Type 2 Diabetes Mellitus by enhancing medication adherence: A multicentre randomised controlled trial with mediation analysis.

Mohd Syamir Mohamad Shukeri·Baharudin Ibrahim·Siew Chin Ong·Hasniza Zaman Huri·Rajat Rana·Tooba Malik·Chow Kyn Ng
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Abstract

AIMS: This study evaluated whether a gamified mHealth application (CareAide&#xae;) improves Health-Related Quality of Life (HRQoL) in Type 2 Diabetes Mellitus (T2DM) and whether this effect is mediated by medication adherence. METHODS: Prespecified secondary analysis of the T2DM cohort from a 6-month multicentre RCT (NCT06068309; N&#x202f;=&#x202f;663; three Malaysian hospitals). Participants were randomised 1:1 to standard care or CareAide&#xae;. Adherence (MMAS-8), EQ-5D-5L utility (Malaysian value set), and AQoL-6D were assessed at baseline and 6 months. Simple mediation analysis (PROCESS Model 4; 5000 bootstraps) adjusted for baseline HRQoL. RESULTS: CareAide&#xae; significantly predicted higher MMAS-8 scores (mean difference +1.756; d = 1.638; p&#x202f;<&#x202f;0.001). Higher MMAS-8 scores significantly predicted improved AQoL-6D utility (b = 0.024; p&#x202f;<&#x202f;0.001). The direct effect on AQoL-6D was non-significant (p&#x202f;=&#x202f;0.248). Bootstrapped indirect effect confirmed full mediation via AQoL-6D (0.042; 95% CI [0.024, 0.060]). A sensitivity analysis adjusting for baseline HbA1c confirmed full mediation (indirect = 0.034; 95% CI [0.015, 0.052]; n&#x202f;=&#x202f;563). EQ-5D-5L utility showed a significant direct between-group difference at 6 months (p&#x202f;=&#x202f;0.012) but did not operate as a mediation outcome. CONCLUSIONS: Medication adherence fully mediates the AQoL-6D HRQoL benefit of a gamified mHealth intervention in T2DM, as confirmed by both the primary and HbA1c-adjusted sensitivity analyses. These findings support integration of behaviourally informed digital adjuncts into routine primary diabetes care.

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HumansDiabetes Mellitus, Type 2Quality of LifeMedication AdherenceFemaleMiddle AgedMaleHypoglycemic AgentsTreatment OutcomeMalaysiaAdherence InterventionsAgedTime FactorsMobile ApplicationsMediation AnalysisTelemedicineDigital HealthBiomarkersGlycemic ControlHRQoLMediation analysisMedication adherenceRandomised controlled trialType 2 Diabetes MellitusmHealthJournal ArticleMulticenter StudyRandomized Controlled Trial

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Mohd Syamir Mohamad Shukeri, Baharudin Ibrahim, Siew Chin Ong, Hasniza Zaman Huri, Rajat Rana, Tooba Malik, Chow Kyn Ng. 2026-08-13. Mobile health apps improve Health-Related Quality of Life in Type 2 Diabetes Mellitus by enhancing medication adherence: A multicentre randomised controlled trial with mediation analysis.. https://doi.org/10.1016/j.pcd.2026.08.001

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