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NCT Number: NCT07469904

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gotong Royong Hospital Surabaya

Surabaya, East Java, 60119, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Usual Care

Other

Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.

Primary outcomes

  1. Change in COPD health status

    Time frame: 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.

Secondary outcomes

  1. Change in inhaler technique score

    Time frame: Baseline, 1 month, 2 months and 3 months

    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.

  2. Change in adherence to the inhalation regimen

    Time frame: Baseline, 1 month, 2 months and 3 months

    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.

  3. Change in COPD-related health knowledge

    Time frame: Baseline, 1 month, 2 months and 3 months

    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.

  4. Change in dyspnea severity

    Time frame: Baseline, 1 month, 2 months, and 3 months

    Dyspnea severity will be assessed using the modified Medical Research Council (mMRC) dyspnea scale.

  5. Change in respiratory quality of life

    Time frame: Baseline, 1 month, 2 months, and 3 months

    Quality of life will be assessed using the St George's Respiratory Questionnaire (SGRQ).

Study contacts

Contact information is provided by the study sponsor or research team.

Galuh Nawang Prawesti, Master of Clinical Pharmacy

CONTACT

[email protected]

+6281235111205

Sponsors and collaborators

Lead sponsor

Universitas Katolik Widya Mandala Surabaya

Other

Collaborators

  • Taipei Medical University

Registry information

Official study title

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

Acronym: AERIS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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