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Enrolling by invitationNCT06201104Updated Jan 11, 2024

Patient Empowerment Training for COPD Patients

An interventional study of Patient empowerment education in Chronic Obstructive Pulmonary Disease, sponsored by Istanbul University - Cerrahpasa. Enrolling by invitation at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-11.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 5 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
182
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • patient
  • empowerment education
  • self-efficacy
  • health locus of control
  • quality of nursing care
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's planned enrollment of 182 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • General health condition is not suitable to participate in the training.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
182 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherPatient 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.

06

What researchers measure

Primary outcomes

  1. Change in patients' self-efficacy after education

    Scales

    Time frame: Two months

  2. Change in patients' health locus of control after education

    Scales

    Time frame: Two months

  3. Change in patients' perception of nursing care quality after education

    Scales

    Time frame: Two months

07

Study locations

1 site
  • Istanbul University- Cerrahpasa
    Istanbul, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06201104
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Filiz Ozbey (Nurse, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Jan 11, 2024
Start date
Jan 1, 2024 (estimated)
Primary completion
Apr 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jan 11, 2024

Study contacts

Betül Sönmez
study director · Istanbul University - Cerrahpasa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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