Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05029557 |
Other study ID # |
HasanKU-SAZAK-001 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 27, 2021 |
Est. completion date |
July 10, 2022 |
Study information
Verified date |
February 2024 |
Source |
Hasan Kalyoncu University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Individuals who have COPD need a nursing service, which provides qualified and effective
professional care, self-care, and supportive care to perform their daily life activities, and
improve their quality of life. It is predicted that the Chronic Care-Based Training Program
to be implemented and the follow-ups can increase the level of self-efficacy and
satisfaction, and raise awareness on the management of the disease in patients. The purpose
of the study was to evaluate the effects of the Chronic Care Model based education and
telephone follow-up given to patients with COPD on self-efficacy and patient-reported
outcomes. Also, the Modified Patient-Reported Outcome Scale for Chronic Obstructive Pulmonary
Disease-mCOPD-PRO scale, which will be used in the study, will be adapted into Turkish
language and culture, and will be used in the study after its validity and reliability are
examined.
Description:
Chronic Obstructive Pulmonary Disease is a major global healthcare problem with its high
prevalence, increasing incidence (partly due to population aging), and major serious
personal, social, and economic costs. Individuals who have COPD require a nursing service
that provides qualified and effective professional care, self-care, and supportive care to
perform their daily life activities and improve their quality of life. Nurses have active
roles in the management of COPD as professional members of the team, and perform the roles of
caregiving, consultancy, researcher, manager, and trainer in COPD management. The skills
needed for the management of COPD and the knowledge and interventions to develop these skills
are conceptualized as self-management, which is a complex structure including drug
compliance, smoking cessation, maintaining and increasing exercise capacity, healthy
lifestyle changes that include nutrition regulation, vaccination, and symptom management. The
purpose of "Self-management" in COPD is stated in the GOLD 2021 report as "to provide
motivation, encouragement, and guidance for patients to acquire positive health behaviors and
to gain the ability to cope with their disease". The Self-Management Training and Guidance
provided by healthcare staff must be the basic element of the "Chronic Diseases Care Model"
in the scope of the healthcare provided. Although various models were proposed for chronic
disease management, the best known, most used, and most effective among these is the Chronic
Care Model. The model has the quality of being a roadmap for high-quality and
patient-centered service delivery in chronic diseases. Four components of the Chronic Care
Model will be implemented in the present study, which are; Decision Making Support,
Self-Management Support, Health Services Delivery Plan, and Clinical Information Systems. The
study has a randomized controlled experimental study design. The sampling of the study will
consist of the patients who were diagnosed with COPD, hospitalized in Elbistan State Hospital
Chest Policlinic of Kahramanmaraş Provincial Health Directorate, met the inclusion criteria,
and who volunteer to participate in the study. A total of 66 patients, 33 in the Control
Group, and 33 in the Intervention Group will be randomized into groups in the computer
medium.
According to the intervention protocol of the study,
1. A training booklet will be created for COPD patients in the scope of the Chronic Care
Model self-management support component of the study. The quality of the booklet will be
evaluated by submitting it to expert opinions.
2. Patients who meet the inclusion criteria will be included in the present study as the
Intervention and Control Group according to the randomization list.
3. Patients in the Control and Intervention Group will be interviewed and their pre-test
data will be collected after informed consent is obtained from them. For this purpose,
Patient Information Form, COPD Self-Efficacy Scale, 6MWT, COPD Assessment Test
(CAT),modified Medical Research Council (mMRC) Dyspnea Scale, Modified Patient-Reported
Outcome Scale for Chronic Obstructive Pulmonary Disease (mCOPD-PRO) Scale will be used.
4. After the pre-tests are completed, the patients in the Intervention Group will be given
training (0 months) with the training booklet, which is prepared by the researcher based
on the Chronic Care Model, and which includes information and suggestions about
self-management strategies. The training will be organized in one single session in a
way not to exceed approximately 45-50 minutes.
5. The patients, who will be included in the Intervention Group, will be followed up by
phone every two weeks. Also, reminders and informative information based on the training
booklet will be sent to patients every week in the form of a short message.
6. The patients in the Control Group will continue their routine procedures.
7. Post-tests will be applied to the patients who will be included in the Control and
Intervention Group at the 3rd-month polyclinic follow-up. The Patient Assessment of
Chronic Illness Care (PACIC) will be used in this post-test in addition to the
pre-tests. At the end of the study, Training will be given to the Control Group patients
along with Training Booklet.