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

Parkinson Disease Clinical Trial

Official title:

Turkish Adaptation, Validity and Reliability of "Parkinson's Disease Quality of Life 7 (PDQoL7)" Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230926
• Other study ID #: Gazi University-05.09.2023.2
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: November 11, 2025

Study information

• Verified date: January 2024
• Source: Nigde Omer Halisdemir University
• Contact: Asli ÇELIK, MSc.
• Phone: +90388 311 21 05
• Email: fztaslicelik[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 11, 2025
• Est. primary completion date: November 11, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Quality of Life

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Ankara Medipol University	Ankara
Turkey	Gazi University	Ankara
Turkey	Nigde Ömer Halisdemir University	Nigde

Sponsors (2)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University	Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Disease Quality of Life 7 Questionnaire (PDQoL7)	The questionnaire assesses the quality of life of individuals with PD in the last week based on patient self-report. The questionnaire consists of a total of 7 questions and is answered on a 5-point Likert scale ranging from 0 (never)-4 (always). The total score varies between 0 and 28 points and the higher the score, the more negatively the patients' quality of life is affected.	Baseline
Primary	Parkinson's Disease Questionnaire-39 (PDQ-39)	The Parkinson's Disease Questionnaire (PDQ-39) is the most commonly used questionnaire to assess health-related quality of life specific to PD. The PDQ- 39 includes 39 questions in 8 different domains; mobility (10 questions); activities of daily living (6 questions); emotional state (6 questions); stigma (4 questions); social support (3 questions); cognition (4 questions); communication (3 questions); and physical pain (3 questions). Questions are answered with the last 1 month in mind. For each question, a score is given from 0: no problem at all to 4: constant problem. The lower the total score, the better the quality of life. It is a quality of life questionnaire developed specifically for Parkinson's disease.	Baseline
Primary	Short-Form 36 (SF-36)	SF-36 evaluates the negative and positive aspects of health status. The 8 subscales of the scale consist of a total of 36 questions including I-physical function (10 items), II-social function (2 items), III- role limitation due to physical problems (4 items), IV- role limitation due to emotional problems (3 items), V- mental status (5 items), VI- energy/vitality (4 items), VII-pain (2 items), VIII- general perception of health (5 items). The scores of the subscales range from 0 to 100 (0: indicating poor health status, 100: indicating no problem in health status). As a result, it is possible to obtain separate scores for each subscale. The answers to the items are asked to be based on the person's condition in the last 4 weeks.	Baseline
Secondary	Mini Mental State Examination (MMSE)	MMSE will be used to evaluate cognitive functions. The mini mental test is categorized under five main headings. It consists of 11 items including orientation (10 points), recording memory (3 points), attention and calculation (5 points), recall (3 points) and language (9 points). It is evaluated over 30 points in total. A score between 24-30 points is defined as normal, 18-23 points as mild dementia, and 17 points and below as severe dementia. The average administration time of the test is 10 minutes. Patients scoring 18 and above will be included in the study.	Baseline
Secondary	Unified Parkinson's Disease Rating Scale (UPDRS)	Unified Parkinson's Disease Rating Scale (UPDRS) is a scale created to evaluate the motor performance, mental and spiritual status, and daily life activities of patients diagnosed with PD. The scale consists of a total of 4 sections and 42 items. In the first part, non-motor symptoms such as thoughts, behavior and affect; In the second part, activities of daily living; motor symptoms in the third part; In the fourth section, treatment complications are evaluated. Each item is scored between 0 (no symptoms or signs) and 4 (the most severe symptom or sign possible).	Baseline
Secondary	Modified Hoehn-Yahr Evaluation (MHYE)	Modified Hoehn-Yahr Evaluation (MHYE) used to define the disease stage of patients diagnosed with PD. According to MHYE, the disease consists of 8 stages. It is stated that the disease symptoms worsen as the stage progresses.	Baseline
Secondary	Interview Form	All evaluations will be carried out by face-to-face interview method. Individual characteristics of the patients (gender, age, height, body weight, marital status, education level, dominant extremity, smoking and alcohol consumption habits, use and type of assistive device, how many years the assistive device has been used) and disease-related (year of diagnosis, disease duration Information (such as CV, family history, medications used, surgeries) will be questioned.	Baseline