Self-Management in Adults With Asthma or COPD

NCT07742085 | Completed

• 1 other identifier: hmkü
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-blind (evaluator-blind), parallel-group randomized controlled trial comparing two approaches to home-based pulmonary rehabilitation self-management training in individuals with chronic respiratory disease (asthma or COPD): brochure-based and video-animation-based. The topic is current and clinically relevant; the comparison of digital health literacy and patient education materials is a relatively understudied area in the literature. Sample size calculations were performed, the CONSORT 2010 guidelines were followed, and the statistical method (mixed-design ANOVA) is appropriate to the study question.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Asthma Copd

Keywords

Chronic respiratory disease; asthma; self-management; patient education

Outcome Measures

Primary Outcomes (1)

• Chronic Disease Self-Management Scale

  Self-management was evaluated using the Chronic Disease Self-Management Scale (CDSMS), which comprises 23 items across four subscales: Self-Stigmatization (7 items), Coping with Stigma (5 items), Healthcare Effectiveness (5 items), and Treatment Adherence (6 items). The Turkish adaptation of the scale has shown strong internal consistency, with Cronbach's alpha coefficients between 0.715 and 0.879 (Öztürk et al., 2021). Each item is rated on a five-point Likert scale from 1 (Never) to 5 (Always). The overall score is calculated as the arithmetic mean of all items, where higher scores represent better chronic disease self-management and lower scores indicate poorer self-management (Öztürk et al., 2021).

  At baseline (before the intervention) and at the end of week 6 (immediately after completion of the intervention).

Study Arms (2)

Video Education Group

EXPERIMENTAL

Experimental: Video Education Group Arm Description: Participants assigned to this arm received a six-week, home-based pulmonary rehabilitation self-management program delivered through animated educational videos. They were instructed to follow the program at least three times per week. The videos included respiratory education, correct inhaler technique, breathing exercises, airway clearance techniques, lower-extremity strengthening exercises, and nutritional recommendations.

Other: Video Animation

Brochure Group

ACTIVE COMPARATOR

Active Comparator: Brochure Education Group Arm Description: Participants assigned to this arm received the same six-week, home-based pulmonary rehabilitation self-management program in an illustrated educational brochure. They were instructed to follow the program at least three times per week. The brochure included respiratory education, correct inhaler technique, breathing exercises, airway clearance techniques, lower-extremity strengthening exercises, and nutritional recommendations.

Other: brochure education

Interventions

Video Animation OTHER

All participants received an identical pulmonary rehabilitation self-management program delivered via animated educational videos for home-based use.

Video Education Group

brochure education OTHER

Participants received a home-based pulmonary rehabilitation self-management program in the form of an educational brochure covering disease management, exercise training, and family education

Brochure Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of asthma according to the Global Initiative for Asthma (GINA) 2025 guidelines or chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2026 guidelines Clinically stable while receiving medical treatment For participants with asthma, forced expiratory volume in 1 second (FEV₁) greater than 70% of the predicted value Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• Clinically unstable respiratory condition or acute disease exacerbation Neuromuscular disease Unstable cardiovascular disease Musculoskeletal disorder that could limit participation in the exercise program Cognitive impairment or mental disorder that could interfere with communication or compliance with the study procedures

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Antakya, Hatay, 31010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A Single-Assessor-Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: A Single-Assessor-Blinded Randomized Controlled Trial

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: February 28, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 30, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)