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| Name | Class |
|---|---|
| Taipei Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth Serious Game Intervention | Experimental | Participants will receive a pharmacist-led mobile health serious game designed to support COPD self-management. The application includes educational content, inhaler technique training, medication reminders, and guidance on exacerbation prevention and management. Participants will receive brief guidance from a pharmacist and will use the application at home for 2 weeks, with continued access during the 3-month follow-up period. |
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| Usual Care | Active Comparator | Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist-Led mHealth Serious Game | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 2 months and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 month, 2 months and 3 months |
| Change in adherence to the inhalation regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galuh Nawang Prawesti, Master of Clinical Pharmacy | Contact | +6281235111205 | galuh@ukwms.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Shawn Hsiang-Yin Chen, Professor | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gotong Royong Hospital Surabaya | Surabaya | East Java | 60119 | Indonesia |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Usual Care | Other | Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice. |
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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. |
| 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. | 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. | 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). | Baseline, 1 month, 2 months, and 3 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |