Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease

Официальное название

Evaluation of the Effectiveness of a Pharmacist-Led Interactive Mobile Health Intervention (Serious Games) for Improving Health Outcomes in Adults With COPD (Pilot RCT)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Pharmacist-Led mHealth Serious Game
  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.
• Другое Usual Care
  Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.

Первичные конечные точки

• Change in COPD health status [Срок оценки: Baseline, 1 month, 2 months and 3 months]

Вторичные конечные точки (5)

• Change in inhaler technique score [Срок оценки: Baseline, 1 month, 2 months and 3 months]
• Change in adherence to the inhalation regimen [Срок оценки: Baseline, 1 month, 2 months and 3 months]
• Change in COPD-related health knowledge [Срок оценки: Baseline, 1 month, 2 months and 3 months]
• Change in dyspnea severity [Срок оценки: Baseline, 1 month, 2 months, and 3 months]
• Change in respiratory quality of life [Срок оценки: Baseline, 1 month, 2 months, and 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Gotong Royong Hospital Surabaya — Surabaya

Идентификаторы

NCT: NCT07469904 · AERIS-COPD-PilotRCT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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