Clinical trial NCT06230926: Turkish Adaptation of "Parkinson's Disease Quality of Life 7 (PDQoL7)" Questionnaire
Official title: Turkish Adaptation, Validity and Reliability of "Parkinson's Disease Quality of Life 7 (PDQoL7)" Questionnaire
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Quality of Life
Keywords: Parkinson's disease
Qality of life
Patient Reported Measure
Validity
Reliability
Adaptation
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2024-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research will be carried out in cooperation with Gazi University Faculty of Health Sciences and Niğde Ömer Halisdemir University. Study data will be obtained from individuals diagnosed with PD who apply to Niğde Ömer Halisdemir University Training and Research Hospital Neurology Polyclinic. Necessary permissions were obtained from all institutions and those who developed the survey.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parkinson's Disease Quality of Life 7 Questionnaire (PDQoL7)
timeFrame: Baseline
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: Baseline
measure: Short-Form 36 (SF-36)
timeFrame: Baseline
Secondary outcomes:
measure: Mini Mental State Examination (MMSE)
timeFrame: Baseline
measure: Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline
measure: Modified Hoehn-Yahr Evaluation (MHYE)
timeFrame: Baseline
measure: Interview Form
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Medipol University
city: Ankara
country: Turkey
facility: Gazi University
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University
Study officials:
affiliation: Gazi University
name: İlke KESER, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.