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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversitas Katolik Widya Mandala Surabaya

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: mHealth Serious Game InterventionExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

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

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.

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

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.

Time frame
Baseline, 1 month, 2 months and 3 months
4

Change in dyspnea severity

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitas Katolik Widya Mandala Surabaya

Lead sponsor

Taipei Medical University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: