NCT06201104

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
182

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 31, 2023

Last Update Submit

December 31, 2023

Conditions

Keywords

patientempowerment educationself-efficacyhealth locus of controlquality of nursing care

Outcome Measures

Primary Outcomes (3)

  • Change in patients' self-efficacy after education

    Scales

    Two months

  • Change in patients' health locus of control after education

    Scales

    Two months

  • Change in patients' perception of nursing care quality after education

    Scales

    Two months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

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.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Betül Sönmez

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The data of the research will be collected by a statistics expert who has no knowledge of the research process. Patients will not know which group they are in.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

December 31, 2023

First Posted

January 11, 2024

Study Start

January 1, 2024

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

January 11, 2024

Record last verified: 2023-12

Locations