Clinical trial NCT06707649: The Effectiveness of Self-Management Education and Telephone Follow-up in Patient with COPD Exacerbation
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: mMRC Dyspnea Scale
timeFrame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
measure: The COPD Assessment Test
timeFrame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
measure: Clinical COPD Questionnaire (CCQ)
timeFrame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
measure: The Modified Borg Dyspnea Scale
timeFrame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Secondary outcomes:
measure: Self-Care Agency
timeFrame: will be re-administered in the pre-test and interviews with patients at 1, 3 and 6 months
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Training and Research Hospital
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Yasemin CEYHAN, PhD
role: PRINCIPAL_INVESTIGATOR
References: