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NCT Number: NCT06707649

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

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Self-care Agency Symptom Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kirsehir Training and Research Hospital

Kırşehir, 40200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Yasemin CEYHAN Assistant Professor, PhD

CONTACT

[email protected]

+9054645898065

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. mMRC Dyspnea Scale

    Time frame: 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.

  2. The COPD Assessment Test

    Time frame: 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.

  3. Clinical COPD Questionnaire (CCQ)

    Time frame: 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.

  4. The Modified Borg Dyspnea Scale

    Time frame: 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 outcomes

  1. Self-Care Agency

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasemin CEYHAN

CONTACT

[email protected]

+905464589806

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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