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

NCT06230926 | Completed DMC

• 1 other identifier: Gazi University-05.09.2023.2
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 3

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.

Conditions

Parkinson Disease; Quality of Life

Keywords

Parkinson's disease; Qality of life; Patient Reported Measure; Validity; Reliability; Adaptation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Mini Mental State Examination (MMSE)

  Baseline

• Unified Parkinson's Disease Rating Scale (UPDRS)

  Baseline

• Modified Hoehn-Yahr Evaluation (MHYE)

  Baseline

• Interview Form

  Baseline

Study Arms (1)

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.

Other: Validity, Reliability and Adaptation

Interventions

Validity, Reliability and Adaptation 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.

Parkinson's Disease Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gazi University: collaborator
• Nigde Omer Halisdemir University: lead

Study Sites (3)

Ankara Medipol University

Ankara, 06490, Turkey (Türkiye)

Location

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

Niğde Ömer Halisdemir University

Niğde, 51200, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 35235090 BACKGROUND

• 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.

  PMID: 33372386 BACKGROUND

• 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.

  PMID: 27600287 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Acclimatization

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Adaptation, Physiological; Physiological Phenomena; Adaptation, Biological; Biological Phenomena

Study Officials

• İlke KESER, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT. MSc.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: November 11, 2023
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)