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

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:

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.

Study Overview

• Status: Recruiting
• Conditions: COPD (Chronic Obstructive Pulmonary Disease); Symptom Management; Self-care Agency
• Intervention / Treatment: Other: Self Management Education; Other: Telephone Follow-up

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasemin CEYHAN; Phone Number: +905464589806; Email: yasemin-ceyhan@hotmail.com

Study Locations

• Turkey
  • Kirsehir, Turkey, 40200
    • Recruiting
    • Kirsehir Training and Research Hospital
    • Contact: Yasemin CEYHAN Assistant Professor, PhD; Phone Number: +9054645898065; Email: yasemin-ceyhan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.
Experimental: 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.	Other: 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.
Active Comparator: 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.	Other: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Yasemin CEYHAN, PhD, Kirsehir Ahi Evran Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Estimated): November 27, 2024

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Symptom Management; COPD (Chronic Obstructive Pulmonary Disease); Telephone Follow-up; Self-care Agency
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2024/03/43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No