- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07450885
"Turkish Validation and Reliability Study of the Brompton Breathing Pattern Assessment Tool in Asthma Patients" (BPAT-Turkish)
Validity and Reliability Study of the Turkish Version of the Brompton Breathing Pattern Assessment Tool (BPAT) in Individuals With Asthma
Study Overview
Status
Conditions
Detailed Description
This study is designed to assess the validity and reliability of the Turkish version of the Brompton Breathing Pattern Assessment Tool (BPAT). BPAT is a well-established tool used to assess the breathing patterns of individuals with respiratory conditions. In this study, a group of asthma patients will be evaluated using the BPAT to determine its applicability and consistency in the Turkish-speaking population.
The reliability of the tool will be tested through repeated measurements, and its validity will be assessed by comparing BPAT results with other validated asthma assessment tools. The data will be analyzed to evaluate the internal consistency, test-retest reliability, and construct validity of the BPAT in a clinical asthma population.
The linguistic validation process will be conducted following the ISPOR Task Force guidelines, including forward translation, reconciliation, back-translation, and cognitive debriefing. The psychometric properties of the tool, including internal consistency, test-retest reliability, and construct validity, will be evaluated according to the COSMIN checklist standards.
Additionally, participant eligibility will be defined as individuals who are diagnosed with asthma and can understand and respond to questions in Turkish. The study will also explore any cultural adaptations necessary for the Turkish version of the BPAT to ensure its cultural relevance and accuracy in assessments.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34844
- Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged between 18 and 75 years
- Diagnosed with severe persistent asthma according to the Global Initiative for Asthma (GINA) criteria
- Turkish ethnicity
- Ability to read and write in Turkish
- Willingness to participate in the study
Exclusion Criteria:
- Having had a respiratory infection in the last 1 month
- Use of oral corticosteroids in the last 4 weeks
- Presence of malignancy, vasculitis, or pregnancy
- Body Mass Index (BMI) > 35 kg/m2
- Diagnosis of COPD or other primary respiratory diseases (excluding asthma)
- Any musculoskeletal, neurological, or cardiovascular condition that could interfere with breathing pattern assessment or impede potential respiratory physiotherapy applications
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Asthma Patients
Individuals aged 18-75, diagnosed with severe persistent asthma according to GINA criteria, who are native Turkish speakers.
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A tool used to assess breathing patterns in asthma patients through clinical observation.
A set of validated questionnaires and objective tests used to compare with BPAT results for construct validity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Construct Validity of the Turkish Version of the Brompton Breathing Pattern Assessment Tool (BPAT)
Time Frame: Baseline
|
The study aims to evaluate the construct validity of the Turkish version of the BPAT in assessing breathing patterns among Turkish-speaking asthma patients.
Validity will be determined by calculating correlation coefficients (e.g., Spearman's or Pearson's r) between the total BPAT scores, objective physiological measures (spirometry results such as FEV1 and FVC), and the scores of established reference clinical tools (Nijmegen Questionnaire, Dyspnea-12, Asthma Control Test (ACT), and Asthma Quality of Life Questionnaire (Mini-AQLQ).
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-Retest Reliability of the Turkish Version of BPAT
Time Frame: 7 to 14 days
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This outcome will assess the test-retest reliability of the Turkish version of BPAT by measuring the consistency of the tool in repeated assessments.
The BPAT will be administered twice to the same participants.
Reliability will be evaluated by calculating the Intraclass Correlation Coefficient (ICC).
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7 to 14 days
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Inter-Rater Reliability of the Turkish Version of BPAT
Time Frame: Baseline
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This outcome will assess the inter-rater reliability of the Turkish version of BPAT.
Two independent physiotherapists will evaluate the breathing pattern of the same asthma patient.
The raters will be blinded to each other's scores to determine the consistency of the tool's application between different users.
Reliability will be evaluated by calculating the Intraclass Correlation Coefficient (ICC) or Cohen's Kappa.
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Baseline
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Comparison of BPAT Results with Other Asthma Assessment Tools
Time Frame: Baseline
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Description: This outcome will compare the BPAT results with other validated asthma assessment tools, such as Nijmegen Questionnaire, Dyspnea-12 Questionnaire , spirometry, ACT (Asthma Control Test), and Mini AQLQ (Asthma Quality of Life Questionnaire), to determine the congruence between different assessment methods.
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Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Zuhal Kunduracılar, Prof., İstanbul Gelisim University
- Study Chair: Fatma M. Tepetam, Prof., Saglik Bilimleri Universitesi
- Study Chair: Şeyma Ozden, Dr., Saglik Bilimleri Universitesi
- Principal Investigator: Dilek Unsal, PT PhD(c), Saglik Bilimleri Universitesi
- Study Chair: Nisanur Tutus, PT Phd (c), Saglik Bilimleri Universitesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25/428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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