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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- mMRC Dyspnea Scale
研究概览
简要总结
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:
- Does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with COPD exacerbation?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Under 18 years old
- •Withdrawal from the study at any phase
- •Inability to be contacted by phone/mobile phone,
- •Patient death
结局指标
主要结局
mMRC Dyspnea Scale
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
- Self-Care Agency(will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months)
研究者
Yasemin CEYHAN
Assistant Proffesor
Kirsehir Ahi Evran Universitesi