Patient Compliance With the Spirometry Protocol

NCT05921630 | Completed

• 1 other identifier: SDOGRU-001
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

TEST COMPLIANCE

Keywords

Patient education; respiratory function tests; spirometry; test failure; lung function

Outcome Measures

Primary Outcomes (1)

• Patient spirometry test compliance

  We planned to increase patients' compliance with the spirometry test.

  One year

Secondary Outcomes (1)

• Number of spirometry test repetitions

  One year

Study Arms (4)

Control group

PLACEBO COMPARATOR

Control group The control group was given standard routine information by the technician before spirometry.

Other: Education

Leaflet group

EXPERIMENTAL

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

Video

EXPERIMENTAL

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

Leaflet + Video

EXPERIMENTAL

Education via leaflets + video: Subjects in this group were first given a leaflet and shown the video. They later underwent routine spirometry.

Other: Education

Interventions

Education OTHER

Patient education before pulmonary function test

Control group; Leaflet + Video; Leaflet group; Video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients sent to the spirometry laboratory for forced vital capacity maneuver

You may not qualify if:

• illiterate and had communicational, hearing and visual impairment were excluded

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

University of Gaziantep

Gaziantep, 2700, Turkey (Türkiye)

Location

Related Publications (1)

• Dogru S, Aytac S, Al-Haithamy SAA, Ovayolu O, Sezgi C, Taylan M, Uyar M. Impact of pre-test information on patient compliance with the spirometry protocol: a randomized controlled clinical trial. Eur Rev Med Pharmacol Sci. 2023 Oct;27(20):9754-9761. doi: 10.26355/eurrev_202310_34147.

  PMID: 37916339 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR ASSİSTANT

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 27, 2023
• Study Start: December 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

TU (1)