Self-Management in Adults With Asthma or COPD

NCT07742085 — Not applicable, Completed, 104 participants, Mustafa Kemal University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Single-Assessor-Blinded Randomized Controlled Trial

Registry	NCT07742085
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	104 (Actual)
Sponsor	Mustafa Kemal University (Other)
Conditions	COPD (Chronic Obstructive Pulmonary Disease), Asthma Copd
Interventions	Video Animation, brochure education (Other)
Dates	start 2026-02-28, primary completion 2026-06-01, completion 2026-06-30, first posted 2026-08-03, last updated 2026-08-03
Locations	1 site in Turkey (Türkiye)

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Video Education Group	Experimental	Other: Video Animation	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.
Brochure Group	Active comparator	Other: brochure education	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.

Video Animation (Other): All participants received an identical pulmonary rehabilitation self-management program delivered via animated educational videos for home-based use.
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

+Outcome measures

Primary outcomes

Chronic Disease Self-Management Scale [At baseline (before the intervention) and at the end of week 6 (immediately after completion of the intervention).]: 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).

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Hatay Mustafa Kemal University	Antakya, Hatay	Turkey (Türkiye)

My Notes

Public

To Read Reading Read