The Effectiveness of Self-Management Education and Telephone Follow-up in Patient with COPD Exacerbation

NCT ID: NCT06707649

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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:

1. Does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with COPD exacerbation?
2. 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD (Chronic Obstructive Pulmonary Disease) Symptom Management Self-care Agency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education+Telephone Follow-up

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.

Group Type EXPERIMENTAL

Self Management Education

Intervention Type OTHER

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-up

Intervention Type OTHER

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.

Education

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.

Group Type EXPERIMENTAL

Self Management Education

Intervention Type OTHER

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.

Standard Care

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.

Group Type ACTIVE_COMPARATOR

Self Management Education

Intervention Type OTHER

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-up

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Self Management Education

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.

Intervention Type OTHER

Telephone Follow-up

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* Under 18 years old
* Withdrawal from the study at any phase
* Inability to be contacted by phone/mobile phone,
* Patient death
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yasemin CEYHAN

Assistant Proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yasemin CEYHAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kirsehir Training and Research Hospital

Kırşehir, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yasemin CEYHAN

Role: CONTACT

+905464589806

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yasemin CEYHAN Assistant Professor, PhD

Role: primary

+9054645898065

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024/03/43

Identifier Type: -

Identifier Source: org_study_id