COPD (Chronic Obstructive Pulmonary Disease)NCT07742085
Self-Management in Adults With Asthma or COPD
A study testing Video Animation and brochure education in people with COPD (Chronic Obstructive Pulmonary Disease) and Asthma Copd, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Asthma Copd
- What is being tested?
- Video Animation and brochure education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University
Antakya, Hatay, 31010
About this study
Official title: A Single-Assessor-Blinded Randomized Controlled Trial
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.
- Being tested
- Video Animation, brochure education
- Keywords
- Chronic respiratory disease, asthma, self-management, patient education
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video AnimationOther
All participants received an identical pulmonary rehabilitation self-management program delivered via animated educational videos for home-based use.
brochure educationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: brochure education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline (before the intervention) and at the end of week 6 (immediately after completion of the intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start28 Feb 2026
- Primary completion1 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Single-Assessor-Blinded Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irem Hüzmeli, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742085
- Sponsor's protocol ID
- hmkü
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author, \[İH\], upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Assessor-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07742085
- Acronym / sponsor ID
- hmkü
- Keywords
- Chronic respiratory disease, asthma, self-management, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Single-Assessor-Blinded Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Video Education Group | Experimental | Other: Video AnimationExperimental: 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 educationActive 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video AnimationAll participants received an identical pulmonary rehabilitation self-management program delivered via animated educational videos for home-based use. | Other | Video Education Group |
| brochure educationParticipants received a home-based pulmonary rehabilitation self-management program in the form of an educational brochure covering disease management, exercise training, and family education | Other | Brochure Group |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author, [İH], upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Animation and brochure education in people with COPD (Chronic Obstructive Pulmonary Disease) and Asthma Copd, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.