About this trial
This clinical trial aims to evaluate the effectiveness of a pharmacist-led interactive mobile health intervention (serious game) in adults aged 50 years and older with chronic obstructive pulmonary disease (COPD). The study will test whether the intervention improves health status compared with usual care. Secondary outcomes include inhaler technique, medication adherence, health knowledge, dyspnea, clinical events, healthcare utilization, and costs. Participants in the intervention group will receive pharmacist guidance and use the serious game at home for 2 weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 50 years and older
Diagnosed with chronic obstructive pulmonary disease (COPD) and clinically stable at the time of enrollment
Receiving inhalation therapy
Able to use or access a smartphone
Disqualifiers
Other respiratory diseases (active tuberculosis, lung cancer, asthma, and pneumonia)
Serious comorbidities (renal insufficiency and cardiac failure, terminal illness, life expectancy <6 m)
mental disorders or cognitive dysfunction
auditory, visual, or verbal inability
Trial design
Parallel
Treatments tested in this trial
Pharmacist-Led mHealth Serious Game
BehavioralA mobile health serious game designed to support COPD self-management through interactive learning activities. The application provides education on COPD management, inhaler technique training, medication reminders, and guidance on recognizing and managing exacerbations.
Usual Care
Other interventionParticipants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.
Treatment groups
Trial outcomes
Primary outcomes
Change in COPD health status
Health status will be assessed using the COPD Assessment Test (CAT). The outcome will be defined as the change in CAT score from baseline during the 3-month follow-up period.
Secondary outcomes
Change in inhaler technique score
Inhaler technique will be assessed using a standardized inhaler technique checklist. The outcome will be defined as the change in inhaler technique score from baseline through 3 months, with monthly measurements.
Change in adherence to the inhalation regimen
Adherence to the inhalation regimen will be measured as the ratio of doses taken to doses prescribed on the device. The outcome will be defined as the change in adherence rate from baseline through 3 months, with monthly measurements.
Change in COPD-related health knowledge
COPD-related health knowledge will be measured using a structured knowledge questionnaire (Indonesian version of Health Knowledge of Lung Function Questionnaire Assessment, 25-item). The outcome will be defined as the change in knowledge score from baseline through 3 months, with monthly measurements.
Change in dyspnea severity
Dyspnea severity will be assessed using the modified Medical Research Council (mMRC) dyspnea scale.
Sponsors and contacts
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Universitas Katolik Widya Mandala Surabaya
Lead sponsor
Taipei Medical University
Collaborator
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