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

NCT07469904 | Not Yet Recruiting

• 1 other identifier: AERIS-COPD-PilotRCT-01
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

COPD; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

AERIS; serious games

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, 2 months and 3 months

Secondary Outcomes (5)

• 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

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

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.

mHealth Serious Game Intervention

Usual Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Katolik Widya Mandala Surabaya: lead
• Taipei Medical University: collaborator

Study Sites (1)

Gotong Royong Hospital Surabaya

Surabaya, East Java, 60119, Indonesia

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shawn Hsiang-Yin Chen, Professor

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galuh Nawang Prawesti, Master of Clinical Pharmacy

CONTACT

+6281235111205; galuh@ukwms.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 26, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)