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Parkinson DiseaseNCT06230926

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

An observational study of Parkinson Disease and Quality of Life, run by Nigde Omer Halisdemir University at 3 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Quality of Life
What is being tested?
Validity, Reliability and Adaptation
How many people
129 participants
Where
3 sitesTurkey (Türkiye)
Study dates
11 Nov 2023to 11 Nov 2025
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Turkey (Türkiye)3 sites

  • Ankara Medipol University

    Ankara, 06490

  • Gazi University

    Ankara, 06490

  • Niğde Ömer Halisdemir University

    Niğde, 51200

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Validity, Reliability and Adaptation
Keywords
Parkinson's disease, Qality of life, Patient Reported Measure, Validity, Reliability, Adaptation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Validity, Reliability and AdaptationOther

    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.

Study groups in NCT06230926
Study groupRoleWhat they receive
Parkinson's Disease GroupThe 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.
Receives: Other: Validity, Reliability and Adaptation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Secondary outcomes (4)

  1. 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.

    Measured: Baseline

  2. 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).

    Measured: Baseline

  3. 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.

    Measured: Baseline

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start11 Nov 2023
  3. Primary completion11 Nov 2025
  4. Study completion11 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
129 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06230926
Sponsor's protocol ID
Gazi University-05.09.2023.2
Status last verified
Jan 2026
First submitted
19 Jan 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35235090

  • 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.

    PubMed 33372386

  • 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.

    PubMed 27600287

  • Demirtas A, Iscan D, Kardiyen F, Suicmez S, Keser I. Psychometric properties of the Turkish version of the Parkinson's disease quality of life-7 (PDQoL-7) in older adults. BMC Geriatr. 2026 Apr 14;26(1):722. doi: 10.1186/s12877-026-07458-y.

    PubMed 41975301

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Quality of Life, run by Nigde Omer Halisdemir University at 3 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parkinson's Disease Quality of Life 7 Questionnaire (PDQoL7) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06230926, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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