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Self-Management in Adults With Asthma or COPD

A Single-Assessor-Blinded Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07742085
Enrollment
104
Registered
2026-08-03
Start date
2026-02-28
Completion date
2026-06-30
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Copd, COPD (Chronic Obstructive Pulmonary Disease)

Keywords

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

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.

Interventions

OTHERVideo Animation

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

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

Sponsors

Mustafa Kemal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

A Single-Assessor-Blinded

Intervention model description

A Single-Assessor-Blinded Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic Disease Self-Management ScaleAt 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 4, 2026