COPDNCT05577897
Effectiveness of Education Given to Patients With COPD
A study testing Education in people with COPD, run by Zeynep Yildirim at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effects of chronic obstructive pulmonary disease management education given to patients diagnosed with chronic obstructive pulmonary disease on self-care agency and rational drug use. This study has a pretest-posttest quasi-experimental design. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2020to 12 Jul 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who had been receiving CODP treatment for longer than 6 months
- Patients who had low or moderate levels of self-care agency
- Patients who needed to use medication continuously to treat COPD
- Patients who had no sensory loss related to hearing and vision
- Patients who were open to cooperation and communication and who were oriented
Who cannot join
- Patients who left the study at any stage
- Patients who had been receiving CODP treatment for less than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Education Given to Patients Diagnosed With Chronic Obstructive Pulmonary Disease on Self-care Agency and Rational Drug Use.
This study was conducted to examine the effects of chronic obstructive pulmonary disease management education given to patients diagnosed with chronic obstructive pulmonary disease on self-care agency and rational drug use. This study has a pretest-posttest quasi-experimental design. A total of 83 patients with COPD were randomly assigned to a intervention group or control group, who met the inclusion criteria.
Read the detailed description
COPD, which is one of the most common respiratory system diseases, is an important global health problem. Chronic Obstructive Pulmonary Disease (COPD), which is a disease with significant mortality and morbidity, is characterized by progressive air flow obstruction; it is irreversible and accompanied by multiple symptoms and frequent exacerbations. Among the leading causes of death, COPD is in the fourth place in the world, while it is in the third place in our country.
At the end of the physiopathological processes that occur in COPD, respiratory function is severely impaired, and individuals experience significant levels of limitations while performing their daily living activities due to shortness of breath, cough, fatigue and insomnia. Long-term drug therapy is used commonly to control these limitations in patients with COPD. Increased dyspnea, activity intolerance, long lasting oxygen and drug therapy, social intolerance and chronic hypoxia cause a decrease in the quality of life and psychological problems. It is important for patients to have sufficient level of self-care agency and to take responsibility for their self-care to control COPD symptoms. Self-care management consists of behaviors performed to manage the symptoms of the disease or to manage the side effects of the treatment. In patients with COPD, self-care is specifically important since it can improve health-related quality of life and decrease hospitalization and dispnea.
One of the necessary steps to improve the symptoms and limitations caused by the physiopathological processes that occur in COPD is drug therapy. A large number of drug groups are used in COPD treatment. The aim of drug therapy in COPD is eliminating the symptoms, improving exercise tolerance and health status and increasing future risks (prevention and treatment of attacks, prevention of disease progression and decrease in mortality). Stable COPD treatment should be individualized depending on the symptoms of patients. In patients with COPD, the problem of compliance with medication due to reasons such as insufficient or no training on medication, cognitive or physical insufficiency of patients, educational and sociocultural level difference of patients, not choosing the device suitable for patients, misuse of drug, or the inability to use the drug are very common among patients. Patients should be able to transform rational drug use into behavior and have the required knowledge and attitude levels. In this context, the responsibility of nurses for educating and informing patients emerges.
Education is very important in terms of improving the self-care skills of patients with COPD, increasing their functional abilities, using drugs properly, managing the disease processes and improving quality of life. The effects of the education given on different parameters have been evaluated in literature. Therefore, it is thought that the education given to patients about COPD management may contribute to increasing the self-care agency of the patient and to rational use of drugs. This study was conducted to find out the effects of COPD management education given to patients diagnosed with COPD on self-care agency and rational drug use.
- Conditions
- COPD
- Being tested
- Education
- Keywords
- Patient education, Nurse, COPD, Self-care agency, Rational drug use
- 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.
EducationOther
A separate room in Chest Diseases Clinic was used for the education of the patients in this group for a quiet environment and for the education not to be interrupted. The education of a patient lasted approximately 45 minutes. The education booklet "COPD Guide" on COPD management prepared in line with the literature was given to the patients by the researcher. After the content of the education was explained to the patients, 45-minute of education was given through face-to-face verbal presentation and demonstration method.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education | Experimental | The intervention group was given 45 minutes of training. Receives: Other: Education |
| Control Group | No intervention | Routine nursing care was given to the patients in this group without any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Care Agency Scale
SCAS was developed by Kearney and Fleischer. It was adapted into Turkish by by Nahcivan on healthy young individuals and by Pınar on chronic diseases. SCAS has 35 questions with answers on a 5-point, Likert-type scale (from 1 to 5). A total score below 82 is evaluated as low level of self-care agency, while total score between 82 and 120 is evaluated as moderate level of self-care agency and a total score higher than 120 is evaluated as high level of self-care agency.
Measured: up to 6 weeks
Rational Drug Use Scale
RDUS was developed by Demirtaş et al. to determine rational drug use knowledge levels of adult patients. The 3 Likert-type scale consists of a total of 21 expressions, 10 correct and 11 incorrect. The answers given; Correct answer is scored as 2, I don't know 1, and wrong answer is 0 points. Maximum possible score of the scale is 42. A total score of 35 and higher is evaluated as having rational drug use knowledge.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start11 Dec 2020
- Primary completion25 Jun 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Yildirim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Yildirim, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577897
- Sponsor's protocol ID
- Zeynep
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 13 Oct 2022
- 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 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Education Given to Patients Diagnosed With Chronic Obstructive Pulmonary Disease on Self-care Agency and Rational Drug Use.
- ClinicalTrials.gov ID
- NCT05577897
- Acronym / sponsor ID
- Zeynep
- Conditions
- COPD
- Keywords
- Patient education, Nurse, COPD, Self-care agency, Rational drug use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Zeynep YildirimUniversity, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 25 Jun 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 13 Oct 2022 (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 was conducted to examine the effects of chronic obstructive pulmonary disease management education given to patients diagnosed with chronic obstructive pulmonary disease on self-care agency and rational drug use. This study has a pretest-posttest quasi-experimental design. A total of 83 patients with COPD were randomly assigned to a intervention group or control group, who met the inclusion criteria.
Detailed description
COPD, which is one of the most common respiratory system diseases, is an important global health problem. Chronic Obstructive Pulmonary Disease (COPD), which is a disease with significant mortality and morbidity, is characterized by progressive air flow obstruction; it is irreversible and accompanied by multiple symptoms and frequent exacerbations. Among the leading causes of death, COPD is in the fourth place in the world, while it is in the third place in our country.
At the end of the physiopathological processes that occur in COPD, respiratory function is severely impaired, and individuals experience significant levels of limitations while performing their daily living activities due to shortness of breath, cough, fatigue and insomnia. Long-term drug therapy is used commonly to control these limitations in patients with COPD. Increased dyspnea, activity intolerance, long lasting oxygen and drug therapy, social intolerance and chronic hypoxia cause a decrease in the quality of life and psychological problems. It is important for patients to have sufficient level of self-care agency and to take responsibility for their self-care to control COPD symptoms. Self-care management consists of behaviors performed to manage the symptoms of the disease or to manage the side effects of the treatment. In patients with COPD, self-care is specifically important since it can improve health-related quality of life and decrease hospitalization and dispnea.
One of the necessary steps to improve the symptoms and limitations caused by the physiopathological processes that occur in COPD is drug therapy. A large number of drug groups are used in COPD treatment. The aim of drug therapy in COPD is eliminating the symptoms, improving exercise tolerance and health status and increasing future risks (prevention and treatment of attacks, prevention of disease progression and decrease in mortality). Stable COPD treatment should be individualized depending on the symptoms of patients. In patients with COPD, the problem of compliance with medication due to reasons such as insufficient or no training on medication, cognitive or physical insufficiency of patients, educational and sociocultural level difference of patients, not choosing the device suitable for patients, misuse of drug, or the inability to use the drug are very common among patients. Patients should be able to transform rational drug use into behavior and have the required knowledge and attitude levels. In this context, the responsibility of nurses for educating and informing patients emerges.
Education is very important in terms of improving the self-care skills of patients with COPD, increasing their functional abilities, using drugs properly, managing the disease processes and improving quality of life. The effects of the education given on different parameters have been evaluated in literature. Therefore, it is thought that the education given to patients about COPD management may contribute to increasing the self-care agency of the patient and to rational use of drugs. This study was conducted to find out the effects of COPD management education given to patients diagnosed with COPD on self-care agency and rational drug use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education | Experimental | Other: EducationThe intervention group was given 45 minutes of training. |
| Control Group | No intervention | –Routine nursing care was given to the patients in this group without any training. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who had been receiving CODP treatment for longer than 6 months
- Patients who had low or moderate levels of self-care agency
- Patients who needed to use medication continuously to treat COPD
- Patients who had no sensory loss related to hearing and vision
- Patients who were open to cooperation and communication and who were oriented
Key exclusion criteria (2 listed)
- Patients who left the study at any stage
- Patients who had been receiving CODP treatment for less than 6 months
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 |
|---|---|---|
| EducationA separate room in Chest Diseases Clinic was used for the education of the patients in this group for a quiet environment and for the education not to be interrupted. The education of a patient lasted approximately 45 minutes. The education booklet "COPD Guide" on COPD management prepared in line with the literature was given to the patients by the researcher. After the content of the education was explained to the patients, 45-minute of education was given through face-to-face verbal presentation and demonstration method. | Other | Patient Education |
Primary outcome
Self Care Agency Scale
Time frame: up to 6 weeks
SCAS was developed by Kearney and Fleischer. It was adapted into Turkish by by Nahcivan on healthy young individuals and by Pınar on chronic diseases. SCAS has 35 questions with answers on a 5-point, Likert-type scale (from 1 to 5). A total score below 82 is evaluated as low level of self-care agency, while total score between 82 and 120 is evaluated as moderate level of self-care agency and a total score higher than 120 is evaluated as high level of self-care agency.
Rational Drug Use Scale
Time frame: up to 6 weeks
RDUS was developed by Demirtaş et al. to determine rational drug use knowledge levels of adult patients. The 3 Likert-type scale consists of a total of 21 expressions, 10 correct and 11 incorrect. The answers given; Correct answer is scored as 2, I don't know 1, and wrong answer is 0 points. Maximum possible score of the scale is 42. A total score of 35 and higher is evaluated as having rational drug use knowledge.
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 13 Oct 2022.
- 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.
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 Education in people with COPD, run by Zeynep Yildirim 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 5 inclusion and 2 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 13 Oct 2022. 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?
Self Care Agency Scale (time frame: up to 6 weeks). The study lists 2 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 13 Oct 2022.