COPD (Chronic Obstructive Pulmonary Disease)NCT06707649
The Effectiveness of Self-Management Education and Telephone Follow-up in Patient with COPD Exacerbation
A study testing Self Management Education and Telephone Follow-up in people with COPD (Chronic Obstructive Pulmonary Disease) and Symptom Management, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
According to the 2024 GOLD guidelines, Chronic Obstructive Pulmonary Disease (COPD) is defined as heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Symptom Management, Self-care Agency
- What is being tested?
- Self Management Education and Telephone Follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD for the last 1 year
- Diagnosis of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III or IV COPD documented by pulmonary function testing
- Patients hospitalized for acute exacerbation of COPD;
- Hospitalized for at least 3 days
- Having a personal mobile phone and the ability to use it,
- Being enough conscious and oriented to answer the questions,
- Voluntary patients
Who cannot join
- Under 18 years old
- Withdrawal from the study at any phase
- Inability to be contacted by phone/mobile phone,
- Patient death
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kirsehir Training and Research Hospital
Kırşehir, 40200
Yasemin CEYHAN Assistant Professor, PhD, +9054645898065, yasemin-ceyhan@hotmail.com
About this study
Official title: The Effectiveness of Self-Management Education and Telephone Follow-up on Self-Care Agency and Symptom Management in Patients with COPD Exacerbation: a Randomized Controlled Study
According to the 2024 GOLD guidelines, Chronic Obstructive Pulmonary Disease (COPD) is defined as heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction. COPD is one of the leading causes of mortality and morbidity in Turkey and worldwide. Since COPD is an incurable and lifelong disease, it is important for patients to have high levels of self-management.
The main questions it aims to answer are:
Read more
- Does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with COPD exacerbation?
- Does self-management education effect self-care agency and symptom management in people with COPD exacerbation? This study will evaluate the effect of self-management education and telephone follow-up on self-care agency and symptom management. Patients hospitalized with COPD exacerbation will be trained in the hospital and will be followed up by phone call after discharge. During the study, 3 groups were planned; Group 1 will be educated and followed up by telephone Group 2 will only receive education and no telephone follow-up. Group 3 will not receive education and telephone follow-up, only standard care. It is planned to collect the data from the patients at the beginning of the study, at 1, 3 and 6 months.
Main outcomes:
- Level of self-care agency
- Level of symptom management The results obtained will be interpreted by comparing between 3 groups.
- Being tested
- Self Management Education, Telephone Follow-up
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Symptom Management, Telephone Follow-up, Self-care Agency
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Management EducationOther
Patients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on pursed lip breathing, medication use, oxygen and nebulizer treatments. The education will be accompanied by a educational booklet prepared by researchers and expert opinion.
Telephone Follow-upOther
Patients will receive their first call one week after discharge. The calls will be scheduled weekly during the first month, biweekly in the second month, and monthly starting from the third month. During the calls, it is planned to repeat the educational content and answer the patient's questions.
| Study group | Role | What they receive |
|---|---|---|
| Education+Telephone Follow-up | Experimental | Patients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on pursed lip breathing, medication use, oxygen and nebulizer treatments. Patients will receive their first call one week after discharge. The calls will be scheduled weekly during the first month, biweekly in the second month, and monthly starting from the third month. During the calls, it is planned to repeat the educational content and answer the patient's questions. All scales are planned to be re-administered at 1, 3, and 6 months. Receives: Other: Self Management Education; Other: Telephone Follow-up |
| Education | Experimental | Patients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on puckered lip breathing, medication use, oxygen and nebulizer treatments. Patients in this group will not receive telephone follow-up. All scales are planned to be re-administered at 1, 3, and 6 months. Receives: Other: Self Management Education |
| Standard Care | Active comparator | Patients in this group will receive standard care. Education and telephone follow-up will not be applied. All scales are planned to be re-administered at 1, 3, and 6 months. Receives: Other: Self Management Education; Other: Telephone Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
mMRC Dyspnea Scale
It is used to rate the effects of breathlessness in daily activities. The scale was developed and modified by the British Medical Research Council (MRC) to determine the course of breathlessness in respiratory diseases. The MMRC is a five-item scale based on various movements that cause shortness of breath.
Measured: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
The COPD Assessment Test
The Turkish reliability and validity of the scale, which consists of eight questions to assess health status in COPD, was conducted by Yorgancıoğlu et al. in 2012. The COPD Assessment Test provides assessment of conditions such as sputum, shortness of breath, cough, fatigue, and sleep. Each question is scored between 0 (no symptoms) and 5 (severe symptoms). The scores of the questions in the test are between "0-40". The higher the score, the more severe the disease and the worse the health status.
Measured: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Clinical COPD Questionnaire (CCQ)
It is a 10-item questionnaire (4 items for symptoms, 4 items for functional status and 2 items for mental status) that measures clinical control to assess functional status, mental status and symptoms and is valid and reliable in Turkish.
Measured: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
The Modified Borg Dyspnea Scale
The Modified Borg Dyspnea Scale was developed by Borg in 1970 to measure the effort expended during exercise and the level of dyspnea felt at the maximum level at which exercise has to be stopped. The severity of dyspnea on the scale is expressed by ten items defined from "0 (none)" to "10 (very severe)". The severity of exertion during exercise is graded according to this scoring to determine the level of dyspnea.
Measured: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Secondary outcomes (1)
Self-Care Agency
The scale was developed by Kearney and Fleicher (1979) in English with 43 items, and its Turkish validity and reliability was shortened to 35 items by Nursen Nahcivan (Nahcivan, 1994; Nahcivan 2004). The scale focuses on individuals self-assessment of their involvement in self-care activities. Each statement is scored from 0 to 4. Individuals orientation towards self-care is determined by participants responses on a 5-point Likert-type scale.
Measured: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi
- Investigators
- Yasemin CEYHAN, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707649
- Sponsor's protocol ID
- 2024/03/43
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Self-Management Education and Telephone Follow-up on Self-Care Agency and Symptom Management in Patients with COPD Exacerbation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06707649
- Acronym / sponsor ID
- 2024/03/43
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Symptom Management, Telephone Follow-up, Self-care Agency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Nov 2024 (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.
According to the 2024 GOLD guidelines, Chronic Obstructive Pulmonary Disease (COPD) is defined as heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction. COPD is one of the leading causes of mortality and morbidity in Turkey and worldwide. Since COPD is an incurable and lifelong disease, it is important for patients to have high levels of self-management.
The main questions it aims to answer are:
- Does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with COPD exacerbation?
- Does self-management education effect self-care agency and symptom management in people with COPD exacerbation? This study will evaluate the effect of self-management education and telephone follow-up on self-care agency and symptom management. Patients hospitalized with COPD exacerbation will be trained in the hospital and will be followed up by phone call after discharge. During the study, 3 groups were planned; Group 1 will be educated and followed up by telephone Group 2 will only receive education and no telephone follow-up. Group 3 will not receive education and telephone follow-up, only standard care. It is planned to collect the data from the patients at the beginning of the study, at 1, 3 and 6 months.
Main outcomes:
- Level of self-care agency
- Level of symptom management The results obtained will be interpreted by comparing between 3 groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Education+Telephone Follow-up | Experimental | Other: Self Management Education, Other: Telephone Follow-upPatients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on pursed lip breathing, medication use, oxygen and nebulizer treatments. Patients will receive their first call one week after discharge. The calls will be scheduled weekly during the first month, biweekly in the second month, and monthly starting from the third month. During the calls, it is planned to repeat the educational content and answer the patient's questions. All scales are planned to be re-administered at 1, 3, and 6 months. |
| Education | Experimental | Other: Self Management EducationPatients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on puckered lip breathing, medication use, oxygen and nebulizer treatments. Patients in this group will not receive telephone follow-up. All scales are planned to be re-administered at 1, 3, and 6 months. |
| Standard Care | Active comparator | Other: Self Management Education, Other: Telephone Follow-upPatients in this group will receive standard care. Education and telephone follow-up will not be applied. All scales are planned to be re-administered at 1, 3, and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with COPD for the last 1 year
- Diagnosis of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III or IV COPD documented by pulmonary function testing
- Patients hospitalized for acute exacerbation of COPD;
- Hospitalized for at least 3 days
- Having a personal mobile phone and the ability to use it,
Key exclusion criteria (4 listed)
- Under 18 years old
- Withdrawal from the study at any phase
- Inability to be contacted by phone/mobile phone,
- Patient death
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 |
|---|---|---|
| Self Management EducationPatients in this group will receive self-management education during the 3 days when they are in the hospital. On the first day of the training, COPD disease, causes of the disease, symptoms, reasons for alleviating complaints, practical information for living comfortably with COPD will be given. On the second day, emergency situations in COPD, what is an exacerbation and prevention suggestions and diaphragmatic breathing-cough exercises will be taught. On the last day, training will be given on pursed lip breathing, medication use, oxygen and nebulizer treatments. The education will be accompanied by a educational booklet prepared by researchers and expert opinion. | Other | Education, Education+Telephone Follow-up, Standard Care |
| Telephone Follow-upPatients will receive their first call one week after discharge. The calls will be scheduled weekly during the first month, biweekly in the second month, and monthly starting from the third month. During the calls, it is planned to repeat the educational content and answer the patient's questions. | Other | Education+Telephone Follow-up, Standard Care |
Primary outcome
mMRC Dyspnea Scale
Time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
It is used to rate the effects of breathlessness in daily activities. The scale was developed and modified by the British Medical Research Council (MRC) to determine the course of breathlessness in respiratory diseases. The MMRC is a five-item scale based on various movements that cause shortness of breath.
The COPD Assessment Test
Time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
The Turkish reliability and validity of the scale, which consists of eight questions to assess health status in COPD, was conducted by Yorgancıoğlu et al. in 2012. The COPD Assessment Test provides assessment of conditions such as sputum, shortness of breath, cough, fatigue, and sleep. Each question is scored between 0 (no symptoms) and 5 (severe symptoms). The scores of the questions in the test are between "0-40". The higher the score, the more severe the disease and the worse the health status.
Clinical COPD Questionnaire (CCQ)
Time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
It is a 10-item questionnaire (4 items for symptoms, 4 items for functional status and 2 items for mental status) that measures clinical control to assess functional status, mental status and symptoms and is valid and reliable in Turkish.
The Modified Borg Dyspnea Scale
Time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
The Modified Borg Dyspnea Scale was developed by Borg in 1970 to measure the effort expended during exercise and the level of dyspnea felt at the maximum level at which exercise has to be stopped. The severity of dyspnea on the scale is expressed by ten items defined from "0 (none)" to "10 (very severe)". The severity of exertion during exercise is graded according to this scoring to determine the level of dyspnea.
1 secondary outcome
Self-Care Agency
Time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Yasemin CEYHAN, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Management Education and Telephone Follow-up in people with COPD (Chronic Obstructive Pulmonary Disease) and Symptom Management, run by Kirsehir Ahi Evran Universitesi 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Nov 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin CEYHAN (+905464589806, yasemin-ceyhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mMRC Dyspnea Scale (time frame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months). The study lists 4 primary outcomes in all. 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 27 Nov 2024.