Evaluation of the Effectiveness of a Pharmacist-Led Interactive Mobile Health Intervention (Serious Games) for Improving Health Outcomes in Adults With COPD (Pilot RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in COPD health status
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Able to communicate in Bahasa Indonesia
- •Willing to participate and provide informed consent
排除标准
- •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
- •participation in other intervention studies
研究组 & 干预措施
mHealth Serious Game Intervention
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.
干预措施: Pharmacist-Led mHealth Serious Game (Behavioral)
Usual Care
Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice.
干预措施: Usual Care (Other)
结局指标
主要结局
Change in COPD health status
时间窗: Baseline, 1 month, 2 months and 3 months
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.
次要结局
- Change in inhaler technique score(Baseline, 1 month, 2 months and 3 months)
- Change in adherence to the inhalation regimen(Baseline, 1 month, 2 months and 3 months)
- Change in COPD-related health knowledge(Baseline, 1 month, 2 months and 3 months)
- Change in dyspnea severity(Baseline, 1 month, 2 months, and 3 months)
- Change in respiratory quality of life(Baseline, 1 month, 2 months, and 3 months)
研究者
Galuh Nawang Prawesti
Principal Investigator
Universitas Katolik Widya Mandala Surabaya