NCT06551103

Brief Summary

This study was conducted as a randomized controlled experimental study. The study was conducted with patients hospitalized in the chest diseases intensive care unit of a state hospital. The study was terminated with the participation of 140 patients, 70 in each group. Data were collected with Descriptive Information Form and COPD Self-Efficacy Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

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

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

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 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 9, 2024

Last Update Submit

August 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Self-Efficacy

    Self-efficacy was assessed with the COPD Self-Efficacy Scale. The 34-item COPD Self-Efficacy Scale has 5 sub-dimensions. The items in the scale are ranked from very safe (5 points) to not safe at all (1 point) and are Likert-type. In the evaluation of the scale, the higher the score obtained from the scale, the higher the competence level of the individual in managing respiratory difficulty.

    3 months after the first test

Study Arms (2)

Intervention group trained in line with the Health Promotion Model

EXPERIMENTAL

A literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each.

Behavioral: Intervention group trained in line with the Health Promotion Model

Control group

NO INTERVENTION

The control group was subjected to the clinic's standard procedures.

Interventions

A literature review was conducted by the researchers within the scope of Health Promotion Model and a educational material was prepared. With this educational material, the patients in the intervention group were trained in four sessions lasting 25 minutes each.

Intervention group trained in line with the Health Promotion Model

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being 18 years of age or older,
  • having been diagnosed with COPD at least 6 months ago,
  • volunteering to participate in the study,
  • being able to speak and understand Turkish and communicate effectively,
  • not having a mental or physical disability that would prevent answering the questions.

You may not qualify if:

  • having a psychiatric illness,
  • having vision and hearing problems,
  • having cognitive dysfunction,
  • not volunteering to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevda Korkut

Talas, Kayseri, 0(553) 310 49 51, 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

  • SEVDA KORKUT

    TC Erciyes University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof.

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

December 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations