---
title: Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease
nct_id: NCT07469904
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Universitas Katolik Widya Mandala Surabaya
study_type: INTERVENTIONAL
primary_condition: COPD
countries: Indonesia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07469904.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07469904"
ct_last_update_post_date: 2026-03-27
last_seen_at: "2026-05-12T06:41:08.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Mobile Health Self-Management Intervention for Patient With Chronic Obstructive Pulmonary Disease

**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)

**NCT ID:** [NCT07469904](https://clinicaltrials.gov/study/NCT07469904)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 126
- **Lead Sponsor:** Universitas Katolik Widya Mandala Surabaya
- **Collaborators:** Taipei Medical University
- **Conditions:** COPD, COPD (Chronic Obstructive Pulmonary Disease)
- **Start Date:** 2026-03-26
- **Completion Date:** 2026-07
- **CT.gov Last Update:** 2026-03-27

## 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.

## 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.

## Eligibility

- **Minimum age:** 50 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **Usual Care** (ACTIVE_COMPARATOR) — Participants will receive usual COPD care and routine education provided by healthcare professionals according to standard clinical practice.

## 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.
- **Usual Care** (OTHER) — Participants will receive standard COPD care and routine education provided by healthcare professionals according to usual clinical practice.

## Primary Outcomes

- **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

- **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)_

## Locations (1)

- Gotong Royong Hospital Surabaya, Surabaya, East Java, Indonesia

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gotong royong hospital surabaya|surabaya|east java|indonesia` — added _(2026-05-12)_

---

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