NCT05577897

Brief Summary

This study was conducted to examine the effects of chronic obstructive pulmonary disease management education given to patients diagnosed with chronic obstructive pulmonary disease on self-care agency and rational drug use. This study has a pretest-posttest quasi-experimental design. A total of 83 patients with COPD were randomly assigned to a intervention group or control group, who met the inclusion criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2021

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

September 27, 2022

Last Update Submit

October 11, 2022

Conditions

COPD

Keywords

Patient educationNurseCOPDSelf-care agencyRational drug use

Outcome Measures

Primary Outcomes (2)

  • Self Care Agency Scale

    SCAS was developed by Kearney and Fleischer. It was adapted into Turkish by by Nahcivan on healthy young individuals and by Pınar on chronic diseases. SCAS has 35 questions with answers on a 5-point, Likert-type scale (from 1 to 5). A total score below 82 is evaluated as low level of self-care agency, while total score between 82 and 120 is evaluated as moderate level of self-care agency and a total score higher than 120 is evaluated as high level of self-care agency.

    up to 6 weeks

  • Rational Drug Use Scale

    RDUS was developed by Demirtaş et al. to determine rational drug use knowledge levels of adult patients. The 3 Likert-type scale consists of a total of 21 expressions, 10 correct and 11 incorrect. The answers given; Correct answer is scored as 2, I don't know 1, and wrong answer is 0 points. Maximum possible score of the scale is 42. A total score of 35 and higher is evaluated as having rational drug use knowledge.

    up to 6 weeks

Study Arms (2)

Patient Education

EXPERIMENTAL

The intervention group was given 45 minutes of training.

Other: Education

Control Group

NO INTERVENTION

Routine nursing care was given to the patients in this group without any training.

Interventions

EducationOTHER

A separate room in Chest Diseases Clinic was used for the education of the patients in this group for a quiet environment and for the education not to be interrupted. The education of a patient lasted approximately 45 minutes. The education booklet "COPD Guide" on COPD management prepared in line with the literature was given to the patients by the researcher. After the content of the education was explained to the patients, 45-minute of education was given through face-to-face verbal presentation and demonstration method.

Patient Education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had been receiving CODP treatment for longer than 6 months
  • Patients who had low or moderate levels of self-care agency
  • Patients who needed to use medication continuously to treat COPD
  • Patients who had no sensory loss related to hearing and vision
  • Patients who were open to cooperation and communication and who were oriented

You may not qualify if:

  • Patients who left the study at any stage
  • Patients who had been receiving CODP treatment for less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep YILDIRIM

Erzurum, Yakutiye, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 27, 2022

First Posted

October 13, 2022

Study Start

December 11, 2020

Primary Completion

June 25, 2021

Study Completion

July 12, 2021

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)