Development and Validation of a Theory-Guided, Evidence-Based Protocol for Inhaler Adherence in Rural Patients with Chronic Obstructive Pulmonary Disease

<title>Abstract</title> <p>Background Adherence to inhalers is essential for optimal therapeutic outcomes in chronic obstructive pulmonary disease (COPD) management. However, the prevalence of poor inhaler adherence reaches 69.9% among rural Chinese patients with COPD, significantly exceeding the rate in urban populations. Existing interventions developed in urban settings may not translate effectively to rural contexts. This study aimed to develop and validate an evidence-based protocol to improve inhaler adherence among rural Chinese patients with COPD. Methods Following Phase 1 of the Medical Research Council (MRC) framework for complex intervention development, the protocol was constructed by integrating the Fogg Behavior Model (FBM), evidence from a literature review, and semi-structured interview findings with rural Chinese COPD patients. An expert panel subsequently evaluated its applicability and content validity using the Content Validity Index (CVI). Result The preliminary intervention protocol based on the FBM was established, consisting of three core modules: COPD and Inhalation Therapy Cognitive Cultivation, Inhalation Technique Learning, and Inhaler Adherence Formation. Game elements (points, badges, achievements, feedback, and progress bars) and Behavior Change Techniques (goal setting, prompts) were embedded to improve engagement and usability. Expert validation yielded item-level and scale-level CVIs of 1.00, indicating high expert consensus on the content validity of the protocol. Discussion Guided by the MRC framework, this study successfully developed a theory- and evidence-based digital intervention protocol to improve inhaler adherence among rural Chinese patients with COPD. The protocol demonstrated excellent content validity through expert consensus. Future pilot studies are warranted to evaluate its feasibility, acceptability, and preliminary effectiveness in real-world rural settings. Trial registration ChiCTR2600127028</p>