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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06201104
Other study ID # 2022/119
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2024

Study information

Verified date December 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study, planned in a randomized, pre-test, post-test, control group and single-blind research design, is to examine the effect of empowerment training given to inpatients diagnosed with chronic obstructive pulmonary disease (COPD) on the patients' self-efficacy, health locus of control and perception of nursing care quality. The population of the research will consist of patients (N=6000) diagnosed with chronic obstructive pulmonary disease (COPD) who are receiving inpatient treatment in any two chest diseases services of a training and research hospital (EAH) that provides tertiary healthcare services on the European side of Istanbul. Two pulmonology services will be selected by lottery among a total of 9 pulmonology services. Among two chest diseases services, patients will be randomly assigned, one in the experimental group and the other in the control group. Patients' data will be collected with the Introductory Information Form, COPD Information Survey, Generalized Self-Efficacy Scale, Multidimensional Health Locus of Control Scale Form A and Care Behavior Scale-24. The data of the study will be analyzed using descriptive tests, intergroup comparison tests and correlation analysis. Key Words: Patient, empowerment education, self-efficacy, health locus of control, nursing care quality.


Description:

The aim of the study, planned in a randomized, pre-test, post-test, control group and single-blind research design, is to examine the effect of empowerment training given to inpatients diagnosed with chronic obstructive pulmonary disease (COPD) on the patients' self-efficacy, health locus of control and perception of nursing care quality. In line with the purpose of the research, the hypotheses were determined as follows: H1-0: Strength training has no effect on patients' self-efficacy. H1-1: Empowerment training has an effect on patients' self-efficacy. H2-0: Strength training has no effect on patients' health locus of control. H2-1: Strength training has an effect on patients' health locus of control. H3-0: Empowerment education has no effect on patients' perception of nursing care quality. H3-1: Empowerment education has an effect on patients' perception of nursing care quality. The population of the research will consist of patients (N=6000) diagnosed with chronic obstructive pulmonary disease (COPD) who are receiving inpatient treatment in any two chest diseases services of a training and research hospital (EAH) that provides tertiary healthcare services on the European side of Istanbul. Two pulmonology services will be selected by lottery among a total of 9 pulmonology services. Among two chest diseases services, patients will be randomly assigned, one in the experimental group and the other in the control group. The determination of the experimental and control groups will be carried out in a single blind manner and in a computer environment by an external expert. In the research, provided that the number of patients in the experimental and control groups is equal, the patients will be numbered in the order of admission to the ward (taking into account first the date and then the time) until 182 patients are reached and they will be assigned to the experimental and control groups in a random manner. Preliminary implementation of the study will be carried out before patients are assigned to the experimental and control groups. Permission will be obtained for the preliminary application of the research. 3 COPD patients hospitalized in the chest diseases services of EAH and who agree to participate in the preliminary application will be asked to answer the questions in the data collection tools and read the patient empowerment training brochure. Patients' data will be collected with the Introductory Information Form, COPD Information Survey, Generalized Self-Efficacy Scale, Multidimensional Health Locus of Control Scale Form A and Care Behavior Scale-24. The data of the study will be analyzed using descriptive tests, intergroup comparison tests and correlation analysis. Key Words: Patient, empowerment education, self-efficacy, health locus of control, nursing care quality.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 182
Est. completion date December 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 6 months have passed since the diagnosis of COPD, - Having received inpatient treatment in the hospital for at least two nights, - Being conscious, - No communication barrier, - Being literate in Turkish, - Being 18 years or older, - Agreeing to participate in the research. Exclusion Criteria: - General health condition is not suitable to participate in the training.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient empowerment education
After the pre-test is administered to the patients in the experimental group, patient empowerment training (intervention) will be given. Patients will be divided into groups of 15 people and the training will be given in a total of 6 sessions, all in one session. The "Patient Empowerment Handbook" prepared by the researchers will be used during the training. The training was planned to last 1 hour (45 minutes of theoretical training, 15 minutes of question and answer). The training was planned to be carried out in an interactive manner (question and answer method, sharing of patient experiences, group discussion). The "Patient Empowerment Handbook" will be delivered to patients after the training for them to read whenever they want. How to use the manual will be explained to patients.

Locations

Country Name City State
Turkey Istanbul University- Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patients' self-efficacy after education Scales Two months
Primary Change in patients' health locus of control after education Scales Two months
Primary Change in patients' perception of nursing care quality after education Scales Two months
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