Empowering Patients Through Literacy: A Randomized Controlled Trial of an Educational App for Evaluating Complementary Therapies in Diabetes Management

AIMS: This study evaluated the effectiveness of an Educational App for Complementary Therapy in Diabetes Management in improving health literacy, quality of life, and diabetes empowerment through complementary therapy. DESIGN: An assessor- and investigator-blinded randomized controlled trial was conducted. The report of this study adheres to the CONSORT 2025 guideline. METHODS: Eighty-eight participants with type 2 diabetes who reported complementary therapy use were randomly assigned to either an app-based intervention or a standard-education control group. The eight-session intervention incorporated self-control, cognitive, psychological, and behavioural strategies. Outcomes, including diabetes empowerment, complementary therapy health literacy, and quality of life, were assessed at three time points. Data were analysed using generalized estimating equations. RESULTS: Participants in the intervention group demonstrated statistically significant improvements in CT-related critical health literacy and quality of life compared with the control group, but no statistically significant improvement in diabetes empowerment. Results suggest that the educational app enhances individuals' knowledge and capacity to evaluate the use of complementary therapies. CONCLUSIONS: The Educational App for Complementary Therapy in Diabetes Management is a promising digital tool for improving complementary therapy health literacy and quality of life in diabetes care. Although empowerment did not improve, the app's design and alignment with empowerment processes highlight its potential for extended educational and clinical use. Future research should explore longer-term engagement, methods of reinforcement, and broader implementation across diverse populations. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: Healthcare professionals can utilize the app to enhance patient education on the use of complementary therapies, thereby improving communication, shared decision-making, and the overall quality of diabetes management. IMPACT: What problem did the study address? The use of complementary therapy alongside conventional diabetes care is common, yet individuals often lack adequate knowledge to evaluate its potential benefits, risks, and safety. Disclosure of complementary therapy use to healthcare professionals is frequently low, posing risks of adverse interactions and undermining coordinated care. Knowledge, health literacy, and a supportive environment are critical components of chronic disease management, but they are underexplored in the context of digital interventions focused on the use of complementary therapies. What were the main findings? This study evaluates the Educational App for Complementary Therapy in Diabetes Management for smartphones-a digital educational intervention designed to enhance complementary therapy health literacy and safe decision-making among individuals diagnosed with diabetes. The intervention demonstrated statistically significant improvements in complementary therapy health literacy and quality of life, underscoring its potential clinical utility. While diabetes empowerment did not improve within the study period, the intervention's grounding in the WHO empowerment process framework and interactive features suggest that longer or more reinforced exposure may yield stronger health outcomes. Where and on whom will the research have an impact? The app empowers individuals to make safer and more informed decisions regarding complementary therapy use, improving self-management and quality of life. The findings provide a practical digital tool to support safer CT-related decision-making by helping participants appraise CT information, evaluate benefit-risk, and communicate with healthcare professionals. The research supports the integration of digital health literacy interventions into diabetes management programs, promoting evidence-based and patient-centred practice. REPORTING METHOD: This study was reported in accordance with the CONSORT 2025 statement. PATIENT AND PUBLIC INVOLVEMENT: Professional experts contributed to the co-design of the intervention. The intervention was pilot-tested with patients, whose feedback informed protocol refinements to enhance feasibility and acceptability. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06317584.