Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 22, 2025
Date Accepted: Dec 27, 2025
Evaluation of a Tailored Multifaceted Pharmaceutical Care Intervention to Optimize COPD Management (D-PCARE): Protocol for a Cluster Randomized Controlled Trial
ABSTRACT
Background:
Despite the widespread use of inhalation therapy, patients with chronic obstructive pulmonary disease (COPD) often experience suboptimal disease control due to poor medication adherence, incorrect inhaler technique, and inappropriate device selection. These issues collectively impair health-related quality of life (HRQL). Digitally enhanced management targeting adherence, inhaler technique, and device selection offers a potential solution by enabling more effective monitoring and timely interventions.
Objective:
This study aims to evaluate the impact of a digitally supported, theory-driven, multifaceted pharmaceutical care intervention on HRQL in patients with moderate-to-very-severe COPD, while addressing existing evidence gaps.
Methods:
This 1-year cluster randomized controlled trial will enroll adults with moderate-to-very-severe COPD (GOLD stages 2–4). A total of 34 Cough and Wheeze Pharmaceutical Care clinics will be randomized into two groups. The intervention group will receive tailored support incorporating electronic adherence monitoring, inhaler technique assessments, and peak inspiratory flow rate (PIFR) measurements to optimize device selection and self-management. The control group will receive usual pharmaceutical care. The primary outcome is change in HRQL at 12 months, assessed using the St. George’s Respiratory Questionnaire. Secondary outcomes include adherence (Test of Adherence to Inhalers, TAI), health-related quality of life (EQ-5D-5L), healthcare costs, and patient satisfaction with care.
Results:
Participant enrollment began in November 2024 and is expected to conclude in December 2026. The final analysis will be conducted in March 2027 once all data have been collected and thoroughly reviewed.
Conclusions:
This trial is among the first to examine the feasibility and effectiveness of incorporating digital sensors into medication management for COPD. If successful, the intervention could support broader implementation of multifaceted pharmaceutical care models to enhance adherence, optimize inhaler use, and improve device selection in this patient population. Clinical Trial: ChiCTR, ChiCTR2400086943. Registered 15 July 2024; https://www.chictr.org.cn/.
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