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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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