Patient Compliance With the Spirometry Protocol

June 26, 2023 updated by: Sibel Doğru, University of Gaziantep

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Gaziantep, Turkey, 2700
        • University of Gaziantep

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient spirometry test compliance
Time Frame: One year
We planned to increase patients' compliance with the spirometry test.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of spirometry test repetitions
Time Frame: One year
We planned to reduce the number of spirometry tests patients.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Gaziantep

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SDOGRU-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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