A Single-Assessor-Blinded Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mustafa Kemal University
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Chronic Disease Self-Management Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
A Single-Assessor-Blinded
Eligibility Criteria
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Chronic Disease Self-Management Scale
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Irem Hüzmeli
Assoc. Prof.
Mustafa Kemal University