Impact of self-management interventions initiated during hospitalization on inhaler adherence and functional outcomes in patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial
Abstract
Chronic obstructive pulmonary disease (COPD) remains a leading global health burden, with acute exacerbations accelerating functional decline and impairing quality of life. Reduced inhaler adherence is a well-recognized contributor to exacerbations and poorer outcomes in COPD. While self-management interventions are well established in stable COPD, their initiation during acute exacerbations has been inadequately explored. This randomized controlled trial, conducted in a South Indian tertiary hospital between July 2024 and May 2025, evaluated the effectiveness of a structured self-management program initiated during hospitalization for acute exacerbation of COPD. The intervention included individualized counseling, family engagement, structured telephonic follow-ups (weekly for 3 months, then monthly for 3 months), and scheduled outpatient reviews, while controls received standard care. Primary outcomes were inhaler adherence assessed by the Test of Adherence to Inhalers, health-related quality of life (HRQoL) measured with the St. George’s Respiratory Questionnaire (SGRQ), and functional capacity assessed by the six-minute walk test. At six months, good inhaler adherence was observed in 66.7% of the intervention group compared to 10% of controls (p<0.001). The mean between-group difference in six-minute walk distance at six months was 92.8 meters [95% confidence interval (CI): 58.1 to 127.6; p<0.001], favoring the intervention group. HRQoL also improved significantly, with a mean between-group difference in SGRQ score of -38.2 (95% CI: -46.7 to -29.8; p<0.001). These findings indicate that initiating structured self-management during hospitalization for acute exacerbation of COPD results in significant improvements in inhaler adherence, functional capacity, and quality of life. Integrating self-management into acute care pathways may therefore optimize patient-centered outcomes in this high-risk population.
Keywords
Ethics Approval
The institutional Ethics Committee (JIP/D(R)/ IECIS-5/O724/102) for the Interventional Studies and Research Monitoring Committee (JIP/ CON/NRMC/M.Sc./2023/MSN/5) approved the study. The procedures followed were in accordance with the institution's ethical standards. The trial was prospectively registered with the Clinical Trials Registry of India (CTRI/2024/09/073).
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