Patient Compliance With the Spirometry Protocol

Sponsor

University of Gaziantep (Other)

Overall Status

Completed

CT.gov ID

NCT05921630

Collaborator

(none)

450

Enrollment

Location

Arms

Actual Duration (Months)

37.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OBJECTIVE: In this study, the effect of brochure-based and video-assisted information given before spirometry on patient compliance will be evaluated.

PATIENTS AND METHODS: This is a randomized controlled clinical trial. Before the test, subjects in the intervention groups will be shown a brochure explaining the steps of the spirometry protocol and a video prepared for the same purpose. Standard routine information will be given to the control group by the technician before spirometry.

RESULTS: 450 patients will be included in the study. It will be investigated whether there is a difference in terms of test compliance between compliance status and age, gender, smoking status, presence of lung disease, spirometry indication, having spirometry for the first time and those receiving brochure, video and brochure-video information. Multivariate analyzes will be performed among the parameters found to be significant.

Condition or Disease	Intervention/Treatment	Phase
TEST COMPLIANCE	Other: Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Impact of Pre-Test Information on Patient Compliance With the Spirometry Protocol: A Randomised Controlled Clinical Trial

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Sep 1, 2022

Actual Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Control group The control group was given standard routine information by the technician before spirometry.	Other: Education Patient education before pulmonary function test
Experimental: Leaflet group Information via leaflets: The subjects were given a leaflet prepared by the researchers based on literature review . The leaflet contained written and visual information about the steps of spirometry. The patients then underwent routine spirometry.	Other: Education Patient education before pulmonary function test
Experimental: Video Video-assisted education: Using a mobile phone, patients were shown a two-minute video prepared by the researchers in accordance with the guidelines that demonstrated how spirometry is performed.	Other: Education Patient education before pulmonary function test
Experimental: Leaflet + Video Education via leaflets + video: Subjects in this group were first given a leaflet and shown the video. They later underwent routine spirometry.	Other: Education Patient education before pulmonary function test

Outcome Measures

Primary Outcome Measures

Patient spirometry test compliance [One year]
We planned to increase patients' compliance with the spirometry test.

Secondary Outcome Measures

Number of spirometry test repetitions [One year]
We planned to reduce the number of spirometry tests patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients sent to the spirometry laboratory for forced vital capacity maneuver

Exclusion Criteria:

illiterate and had communicational, hearing and visual impairment were excluded

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gaziantep	Gaziantep		Turkey	2700

Sponsors and Collaborators

University of Gaziantep

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sibel Doğru, PROFESSOR ASSİSTANT, University of Gaziantep

ClinicalTrials.gov Identifier:

NCT05921630

Other Study ID Numbers:

SDOGRU-001

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sibel Doğru, PROFESSOR ASSİSTANT, University of Gaziantep

Patient education

respiratory function tests

spirometry

test failure

lung function

Study Results

No Results Posted as of Jun 27, 2023