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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Zeynep YILDIRIM

    Erzurum, Yakutiye, 25100

Other trials in Turkey (Türkiye)

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 groups in NCT05577897
Study groupRoleWhat they receive
Patient EducationExperimentalThe intervention group was given 45 minutes of training.
Receives: Other: Education
Control GroupNo interventionRoutine 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.

  1. 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

  2. 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.

  1. First posted13 Oct 2022
  2. Study start11 Dec 2020
  3. Primary completion25 Jun 2021
  4. Study completion12 Jul 2021

Resources

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)
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

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.

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