Exploration of the health needs of patients with poorly controlled type 2 diabetes using a user-centred co-production approach in the area of mHealth: an exploratory sequential mixed-method protocol

INTRODUCTION: Research on the needs and preferences of patients with poorly controlled type 2 diabetes mellitus (T2DM) with mobile health (mHealth) service is limited. With the principles of co-production, this study aims to address this research gap by exploring the health needs of Chinese patients with poorly controlled T2DM. METHODS AND ANALYSIS: This study uses a three-phase, exploratory sequential mixed-method design. Phase 1 aims to assess the health needs of patients with poorly controlled T2DM by conducting semi-structured interviews with patients, doctors and nurses. Participants will be recruited by purposive sampling with maximum variation. Content analysis will be employed. Phase 2 will form item generation and develop the mHealth need scale. The scale will be subject to pilot testing and psychometric evaluation, including content validity, construct validity, discriminant validity, internal validity and test–retest reliability. Phase 3 will explore the priority of health needs perceived by patients with poorly controlled T2DM through a cross-sectional study. The measurement tools include an mHealth needs scale, the Summary of Diabetes Self-care Activities Questionnaire, the Diabetes Empowerment Scale-Short Form, the Diabetes Health Literacy Scale and the eHealth Literacy Scale. Multiple regression techniques with a hierarchical block design will be used for the model building to identify the factors contributing to the heterogeneity of the perceived mHealth needs. The findings of phase 1 and phase 3 will be integrated using data correlation, comparison and consolidation. ETHICS AND DISSEMINATION: The Ethics Committee of the School of Nursing, Sun Yat-sen University, has approved this study (No. 2021ZSLYEC). The results of this study will be disseminated through conference presentations and peer-reviewed publications.