Turkish Adaptation of "Parkinson's Disease Quality of Life 7 (PDQoL7)" Questionnaire

NCT ID: NCT06230926

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-11

Study Completion Date

2025-11-11

Brief Summary

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Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by the involvement of dopaminergic pathways in the basal ganglia. Motor and non-motor symptoms are frequently observed in PD. These symptoms may negatively affect the quality of life of individuals with PD. Therefore, it is recommended to evaluate the quality of life of individuals with PD and plan appropriate treatments. The "Parkinson's Disease Quality of Life 7 (PDQoL7)" questionnaire is a patient-reported quality of life assessment questionnaire developed specifically for individuals with PD. The questionnaire, which consists of 7 questions in total, evaluates the degree of difficulty the patient has in performing various activities. The aim of this study was to adapt the PDQoL7 questionnaire into Turkish and to establish its validity and reliability.

Detailed Description

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Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by the involvement of dopaminergic pathways in the basal ganglia. Motor and non-motor symptoms are frequently observed in PD. These symptoms may negatively affect the quality of life of individuals with PD. Therefore, it is recommended to evaluate the quality of life of individuals with PD and plan appropriate treatments. The "Parkinson's Disease Quality of Life 7 (PDQoL7)" questionnaire is a patient-reported quality of life assessment questionnaire developed specifically for individuals with PD. The questionnaire, which consists of 7 questions in total, evaluates the degree of difficulty the patient has in performing various activities. The aim of this study was to adapt the PDQoL7 questionnaire into Turkish and to establish its validity and reliability. The study data will be collected in collaboration with Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation and Niğde Ömer Halisdemir University and will be conducted with individuals diagnosed with PD who applied to the Neurology Outpatient Clinic of Niğde Ömer Halisdemir University Training and Research Hospital. Necessary permissions were obtained from all institutions and the people who developed the questionnaire. After the purpose and method of the study were explained to the participants in detail, individuals who voluntarily agreed to participate in the study will be included in the study. The serial approach method will be used when translating the original questionnaire into Turkish. Since at least 5-10 times the number of items in the questionnaire should be included in order to perform factor analysis, a pretest of the questionnaire will be applied to individuals with PD with at least 35-70 participants. "Parkinson's Disease Questionnaire-39" and "Short Form-36" questionnaires will be administered to the patients to assess concurrent validity. To determine test-retest reliability, the PDQoL7 questionnaire will be administered to the same patients 2 weeks later, and correlation analysis and test-retest reliability will be calculated. Cronbach's Alpha Reliability coefficient will be applied to determine the internal consistency of the questionnaire. The construct validity of PDQoL7 will be analyzed by confirmatory factor analysis.

Conditions

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Parkinson Disease Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's Disease Group

The study will be conducted in collaboration with Gazi University Faculty of Health Sciences and Niğde Ömer Halisdemir University. The study data will be obtained from individuals diagnosed with PD admitted to the Neurology Outpatient Clinic of Niğde Ömer Halisdemir University Training and Research Hospital. Necessary permissions were obtained from all institutions and questionnaire developers. Since at least 5-10 times the number of items in the questionnaire (7 items) must include at least 5-10 times the number of participants in order to perform factor analysis, a pretest of the questionnaire will be applied to individuals with PD with at least 35-70 participants.

Validity, Reliability and Adaptation

Intervention Type OTHER

The Hoehn \& Yahr Scale (HDS) and the Unified Parkinson's Disease Rating Scale (UPDRS) will be used for the clinical evaluation and disease staging of the individuals included in the study. In addition to the PDQoL-7 questionnaire, the 'Short Form-36' and 'Parkinson's Disease Questionnaire-39' questionnaires will be administered to patients to assess concurrent validity. Since at least 5-10 times the number of items in the questionnaire (7 items) must include at least 5-10 times the number of participants in order to perform factor analysis, a pretest of the questionnaire will be applied to individuals with PD with at least 35-70 participants. To determine the test-retest reliability, the PDQoL7 questionnaire will be administered again to the same patients after 2 weeks.

Interventions

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Validity, Reliability and Adaptation

The Hoehn \& Yahr Scale (HDS) and the Unified Parkinson's Disease Rating Scale (UPDRS) will be used for the clinical evaluation and disease staging of the individuals included in the study. In addition to the PDQoL-7 questionnaire, the 'Short Form-36' and 'Parkinson's Disease Questionnaire-39' questionnaires will be administered to patients to assess concurrent validity. Since at least 5-10 times the number of items in the questionnaire (7 items) must include at least 5-10 times the number of participants in order to perform factor analysis, a pretest of the questionnaire will be applied to individuals with PD with at least 35-70 participants. To determine the test-retest reliability, the PDQoL7 questionnaire will be administered again to the same patients after 2 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with PD by a neurologist,
* Understands and speaks Turkish,
* Individuals who score 18 points or above from the mini-mental state assessment will be included.

Exclusion Criteria

* People with dementia, hearing and/or vision loss
* Patients who are illiterate will be excluded from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role lead

Responsible Party

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Asli Demirtaş

Lecturer, PT. MSc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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İlke KESER, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Locations

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Ankara Medipol University

Ankara, , Turkey (Türkiye)

Site Status

Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Niğde Ömer Halisdemir University

Niğde, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Fereshtehnejad SM. Strategies to maintain quality of life among people with Parkinson's disease: what works? Neurodegener Dis Manag. 2016 Oct;6(5):399-415. doi: 10.2217/nmt-2016-0020. Epub 2016 Sep 7.

Reference Type BACKGROUND
PMID: 27600287 (View on PubMed)

Stathis P, Papadopoulos G. Evaluation and validation of a patient-reported quality-of-life questionnaire for Parkinson's disease. J Patient Rep Outcomes. 2022 Mar 2;6(1):17. doi: 10.1186/s41687-022-00427-0.

Reference Type BACKGROUND
PMID: 35235090 (View on PubMed)

Zhao N, Yang Y, Zhang L, Zhang Q, Balbuena L, Ungvari GS, Zang YF, Xiang YT. Quality of life in Parkinson's disease: A systematic review and meta-analysis of comparative studies. CNS Neurosci Ther. 2021 Mar;27(3):270-279. doi: 10.1111/cns.13549. Epub 2020 Dec 28.

Reference Type BACKGROUND
PMID: 33372386 (View on PubMed)

Other Identifiers

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Gazi University-05.09.2023.2

Identifier Type: -

Identifier Source: org_study_id

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