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

Not Applicable

Recruiting

• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Symptom Management; Self-care Agency

• Registration Number: NCT06707649
• Lead Sponsor: Kirsehir Ahi Evran Universitesi

Brief 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 (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

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-01
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mMRC Dyspnea Scale	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	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)	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	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.

Secondary Outcome Measures

Name	Time	Method
Self-Care Agency	will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months	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.

Trial Locations

Locations (1)

Kirsehir Training and Research Hospital; 🇹🇷 Kirsehir, Turkey