Patient Empowerment Training for COPD Patients

December 31, 2023 updated by: Filiz Ozbey, Istanbul University - Cerrahpasa (IUC)

The Effect of Patient Empowerment Training on Patients' Self-Efficacy, Health Locus of Control and Perception of Nursing Care Quality

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University- Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients in the experimental group will be given patient empowerment training as an intervention. The aim of the training is to ensure that patients have the knowledge, skills and attitudes necessary to manage the care and treatment processes both during their hospitalization and in their daily lives after discharge.
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.
No Intervention: Control group
After the pre-test data is collected from the control group by face-to-face interview method, no intervention will be made to the control group. At the end of the second month, the same scales will be re-administered over the phone as post-test data.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patients' self-efficacy after education
Time Frame: Two months
Scales
Two months
Change in patients' health locus of control after education
Time Frame: Two months
Scales
Two months
Change in patients' perception of nursing care quality after education
Time Frame: Two months
Scales
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Director: Betül Sönmez, Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 31, 2023

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Estimated)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/119

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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