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

NCT06707649 | Recruiting

• 1 other identifier: 2024/03/43
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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:

• Level of self-care agency
• Level of symptom management The results obtained will be interpreted by comparing between 3 groups.

Conditions

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

Keywords

COPD (Chronic Obstructive Pulmonary Disease); Symptom Management; Telephone Follow-up; Self-care Agency

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Self-Care Agency

  will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months

Study Arms (3)

Education+Telephone Follow-up

EXPERIMENTAL

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; Other: Telephone Follow-up

Education

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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; Other: Telephone Follow-up

Interventions

Self Management Education 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.

Education; Education+Telephone Follow-up; Standard Care

Telephone Follow-up 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+Telephone Follow-up; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Kirsehir Training and Research Hospital

Kırşehir, 40200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasemin CEYHAN, PhD

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasemin CEYHAN

CONTACT

+905464589806; yasemin-ceyhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 27, 2024
• Study Start: September 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)