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

March 23, 2026 updated by: Galuh Nawang Prawesti, Universitas Katolik Widya Mandala Surabaya

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Galuh Nawang Prawesti, Master of Clinical Pharmacy
  • Phone Number: +6281235111205
  • Email: galuh@ukwms.ac.id

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60119
        • Gotong Royong Hospital Surabaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: Usual Care
Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice.
Other: Usual Care
Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 2 months and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 2 months and 3 months
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.
Baseline, 1 month, 2 months and 3 months
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.
Baseline, 1 month, 2 months and 3 months
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.
Baseline, 1 month, 2 months, and 3 months
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).
Baseline, 1 month, 2 months, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Katolik Widya Mandala Surabaya

Collaborators

Taipei Medical University

Investigators

  • Principal Investigator: Shawn Hsiang-Yin Chen, Professor, Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 26, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AERIS-COPD-PilotRCT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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