Endocrinology · Medical Literature
Empowering Patients Through Literacy: A Randomized Controlled Trial of an Educational App for Evaluating Complementary Therapies in Diabetes Management.
Abstract
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. An assessor- and investigator-blinded randomized controlled trial was conducted. The report of this study adheres to the CONSORT 2025 guideline. 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. 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. 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. 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. 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. This study was reported in accordance with the CONSORT 2025 statement. 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. ClinicalTrials.gov identifier: NCT06317584.
Clinical relevance
In adults with type 2 diabetes who use complementary therapies, does an eight-session app-based educational intervention improve diabetes empowerment, complementary-therapy-related health literacy, and quality of life compared with standard education? __SNAPSHOT__ {"studyDesign":"Assessor- and investigator-blinded randomized controlled trial; reported in accordance with CONSORT 2025 guidelines","setting":"Not reported (country and institution type not specified in the available abstract)","sampleSize":"n = 88 (intervention: not reported, control: not reported; exact allocation not specified in abstract)","population":"Adults with type 2 diabetes who self-reported current use of complementary therapies","intervention":"Eight-session app-based educational program ('Educational App for Complementary Therapy in Diabetes Management') incorporating self-control, cognitive, psychological, and behavioural strategies","comparator":"Standard-education control group","primaryOutcome":"Not explicitly designated as a single primary outcome in the abstract; three co-outcomes assessed: (1) diabetes empowerment, (2) complementary-therapy (CT)-related critical health literacy, and (3) quality of life — measured at three time points","followUp":"Not reported (number and timing of the three assessment points not specified in the abstract)","fundingSource":"Not reported"}
Key findings
Among 88 participants with type 2 diabetes who used complementary therapies, the intervention group demonstrated statistically significant improvements in CT-related critical health literacy and quality of life compared with the control group. No statistically significant improvement in diabetes empowerment was observed. Specific effect sizes, between-group mean differences, confidence intervals, and p-values are not reported in the available abstract. NNT/NNH cannot be calculated. Data were analysed using generalised estimating equations, which appropriately accounts for repeated measurements across the three time points. No adverse events were described in the abstract.
Practice implications
This trial suggests that a structured, app-based educational intervention targeting complementary-therapy literacy can improve CT-related critical health literacy and quality of life in T2DM patients who already use complementary therapies. However, the intervention did not achieve a statistically significant effect on diabetes empowerment, which is a clinically meaningful patient-centred outcome; this null finding warrants careful interpretation given the small sample size (n = 88), which may have limited power to detect a true effect. Findings apply specifically to T2DM patients who actively use complementary therapies and may not generalise to those who do not. The abstract does not report whether improvements in health literacy or quality of life translated into changes in glycaemic control, medication adherence, or safety outcomes related to complementary-therapy use. Because only the abstract is available, magnitude of effect, clinical importance of statistically significant findings, and direction and size of the null empowerment result cannot be fully evaluated. Practice change is not warranted on this evidence alone; the results are hypothesis-generating and support further confirmatory research. __LIMITATIONS__ Small sample size (n = 88) limits statistical power, particularly for the null diabetes empowerment finding, and increases risk of Type II error.,Exact allocation numbers per arm, randomisation sequence, and allocation concealment method are not described in the abstract.,Assessor and investigator blinding are reported, but participant blinding is not possible in behavioural/app interventions, introducing performance and detection bias risk.,Three time points are mentioned but the duration and spacing of follow-up are not reported, precluding assessment of sustainability of effects.,No single primary outcome is pre-specified in the abstract; multiple co-outcomes inflate risk of false-positive findings.,Effect sizes, confidence intervals, and p-values are not reported in the abstract, making it impossible to judge clinical magnitude of statistically significant results.,Restricted to T2DM patients who self-report complementary-therapy use, limiting generalisability to other diabetes populations.,No reporting of glycaemic outcomes (e.g., HbA1c), complementary-therapy safety events, or medication interactions, which are clinically critical in this context.,Funding source is not reported; potential conflicts of interest cannot be assessed.,Only the abstract is available; full evaluation of methods, results tables, and discussion is not possible. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ An eight-session app-based educational intervention significantly improved CT-related critical health literacy and quality of life in T2DM patients who use complementary therapies, but did not significantly improve diabetes empowerment. With only 88 participants, no reported effect sizes, and no glycaemic or safety outcomes, these results are preliminary and insufficient to justify routine clinical adoption. Replication in larger, adequately powered trials with longer follow-up and clinically meaningful endpoints is needed before practice change can be recommended.