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.
Chronic obstructive pulmonary disease (COPD) is a progressive respiratory disease that requires long-term self-management to control symptoms and prevent exacerbations. However, many patients experience difficulties in maintaining proper inhaler technique, adhering to medication, and recognizing early signs of exacerbation. Digital health interventions may provide additional support to improve patients' knowledge and self-management behaviors. This study evaluates a pharmacist-led interactive mobile health intervention delivered through a serious game designed to support COPD self-management. The intervention includes educational content, inhaler technique training, medication reminders, and guidance on exacerbation prevention and management. Participants will receive pharmacist guidance on how to use the application and will be asked to play the game at home for two weeks. The study is designed as a pilot randomized controlled trial comparing the serious game intervention with usual care in adults aged 50 years and older with COPD. The trial will assess whether the intervention can improve patients' self-management and health outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
A 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.
Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.
Gotong Royong Hospital Surabaya
Surabaya, East Java, Indonesia
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.
Time frame: Baseline, 1 month, 2 months and 3 months
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.
Time frame: Baseline, 1 month, 2 months and 3 months
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.
Time frame: Baseline, 1 month, 2 months and 3 months
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.
Time frame: Baseline, 1 month, 2 months and 3 months
Change in dyspnea severity
Dyspnea severity will be assessed using the modified Medical Research Council (mMRC) dyspnea scale.
Time frame: Baseline, 1 month, 2 months, and 3 months
Change in respiratory quality of life
Quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ).
Time frame: Baseline, 1 month, 2 months, and 3 months
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