NCT07419906

Brief Summary

COPD is a progressive and irreversible lung disease characterized by persistent airflow limitation, dyspnea, chronic cough, and impaired daily functioning, often accompanied by comorbidities that reduce quality of life. Despite its high prevalence in Taiwan, COPD remains underdiagnosed and undertreated. This study aims to evaluate a transtheoretical model-based digital multimedia nursing education intervention for elderly patients with COPD. The intervention is designed to enhance disease knowledge, promote self-care behaviors, and improve self-management abilities, ultimately supporting better quality of life and daily functioning in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
Last Updated

February 19, 2026

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

August 4, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

COPDelderly patientsself-managementdigital multimedia

Outcome Measures

Primary Outcomes (1)

  • COPD assessment test; CAT

    The CAT is an 8-item questionnaire assessing the impact of COPD on health status and daily functioning. Higher scores indicate greater disease burden. This study evaluates the effectiveness of a digital multimedia nursing education intervention in improving disease knowledge, self-care, and self-management.

    Baseline (Week 1), Week 8, and Week 12

Secondary Outcomes (2)

  • Knowledge of COPD Score

    Baseline (Week 1), Week 8, and Week 12

  • Self-Care Behavior Score

    Baseline (Week 1), Week 8, and Week 12

Study Arms (2)

E-book on Pulmonary Obstruction

EXPERIMENTAL

A experimental design was adopted. Simple random sampling was performed to divide the subjects into the traditional teaching material-based intervention group and digital teaching material-based intervention group. A total of 51 patients with COPD and aged ≥60 years were recruited from the outpatient department of a hospital in northern Taiwan. The two groups respectively received health education through traditional paper teaching materials and digital multimedia teaching materials; 50-minute interventions were conducted once per week for 8 weeks, and measurements were taken before the interventio, 8 and 12 weeks after the intervention. Regarding the performance indicators, a paired t test and generalized estimating equation (GEE) were used to analyse differences in the COPD Assessment Test (CAT)、self-care efficiency scale for COPD and COPD knowledge scale.

Behavioral: E-book on Pulmonary Obstruction

The traditional teaching material-based group

NO INTERVENTION

The traditional teaching intervention group used the same health education content of the "E-book on Pulmonary Obstruction" printed into a paper manual for one-on-one teaching, and the same instructor provided health education guidance.

Interventions

The digital teaching intervention group used a computer-downloaded "E-book on Pulmonary Obstruction" for one-on-one teaching. The subjects were also taught how to use their mobile phones to download the "E-book on Pulmonary Obstruction" and how to read it, so that they could use it on their own after returning home. The intervention time for both groups was once a week for 50 minutes each time for a total of 8 weeks. The teaching content is divided into eight themes: (1) How much do you know about pulmonary obstruction? (2) Inhalation treatment for pulmonary obstruction - Introduction to inhalers? (3) Care for pulmonary obstruction - Breathing exercise techniques? (4) Activities and exercise training? (5) Self-management methods for acute pulmonary obstruction? (6) Lung rehabilitation for pulmonary obstruction? (7) Nutritional care for pulmonary obstruction? (8) Care for pulmonary obstruction - Smoking cessation?

E-book on Pulmonary Obstruction

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with pulmonary obstruction after evaluation by a physician.
  • Elderly people aged 60 years or above.
  • Those who are literate, have clear consciousness and can communicate in Chinese and Taiwanese.
  • Those who agree to participate in this research and sign the consent form.

You may not qualify if:

  • Patients with respiratory distress syndrome.
  • Those who use respirators.
  • Those who are unable to communicate due to cognitive impairment due to major mental illness or dementia.
  • Color blindness and visual impairment.
  • Those who do not have mobile phones or tablet computers at home and cannot obtain electronic equipment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiwan

New Taipei City, Taiwan, 243, Taiwan

Location

Related Publications (1)

  • Farmahini Farahani M, Purfarzad Z, Ghorbani M, Ghamari Zare Z, Ghorbani F. The impact of Multimedia Software Support on the Knowledge and Self-Care Behaviors of Patients with Type 2 Diabetes: a Randomized Clinical Trial. J Caring Sci. 2016 Jun 1;5(2):111-20. doi: 10.15171/jcs.2016.012. eCollection 2016.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blind Studies
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A experimental design was adopted
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

August 4, 2025

First Posted

February 19, 2026

Study Start

May 11, 2020

Primary Completion

August 11, 2021

Study Completion

December 23, 2023

Last Updated

February 19, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations