COPDAERISNCT07469904
Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease
A study testing Pharmacist-Led mHealth Serious Game in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- COPD, COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Pharmacist-Led mHealth Serious Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Apr 2026to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
Read the 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.
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease)
- Being tested
- Pharmacist-Led mHealth Serious Game, Usual Care
- Keywords
- AERIS, serious games
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-Led mHealth Serious GameBehavioural
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 CareOther
Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Pharmacist-Led mHealth Serious Game |
| Usual Care | Active comparator | Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 2 months and 3 months
Secondary outcomes (5)
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.
Measured: Baseline, 1 month, 2 months and 3 months
Change in adherence to the inhalation regimen
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 1 month, 2 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start2 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completion8 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Katolik Widya Mandala Surabaya
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University
- Responsible party
- Principal investigator, Galuh Nawang Prawesti, Universitas Katolik Widya Mandala Surabaya
- Investigators
- Shawn Hsiang-Yin Chen, Professor, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469904
- Sponsor's protocol ID
- AERIS-COPD-PilotRCT-01
- Acronym
- AERIS
- Status last verified
- Aug 2026
- First submitted
- 9 Mar 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07469904
- Acronym / sponsor ID
- AERIS / AERIS-COPD-PilotRCT-01
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease)
- Keywords
- AERIS, serious games
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Universitas Katolik Widya Mandala SurabayaUniversity, hospital or other
- Collaborators
- Taipei Medical University
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 8 Sep 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth Serious Game Intervention | Experimental | Behavioral: Pharmacist-Led mHealth Serious GameParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-Led mHealth Serious GameA 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. | Behavioural | mHealth Serious Game Intervention |
| Usual CareParticipants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice. | Other | Usual Care |
Primary outcome
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.
5 secondary outcomes
Change in inhaler technique score
Time frame: 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
Change in COPD-related health knowledge
Time frame: Baseline, 1 month, 2 months and 3 months
Change in dyspnea severity
Time frame: Baseline, 1 month, 2 months, and 3 months
Change in respiratory quality of life
Time frame: Baseline, 1 month, 2 months, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn Hsiang-Yin Chen, Professor principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-Led mHealth Serious Game in people with COPD and COPD (Chronic Obstructive Pulmonary Disease), run by Universitas Katolik Widya Mandala Surabaya at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in COPD health status (time frame: Baseline, 1 month, 2 months and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.