Parkinson DiseaseNCT06892717
Caregiver Burden in Parkinson's Disease
An observational study of Parkinson Disease, run by Beylikduzu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Primary caregivers of patients diagnosed with idiopathic Parkinson's disease will be included in the study. A total of 43 participants will be recruited. At the beginning of the study, demographic data and clinical characteristics of the patients, including disease stage, history of falls, presence of fractures… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 10 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- Adult, Older adult
Study population: The study population will consist of caregivers of patients diagnosed with Parkinson's disease, aged between 40-80 years, who meet the inclusion criteria.
Who may be able to join
- Age between 40-80 years
- Diagnosed with Parkinson's disease, Hoehn and Yahr stage 2-5
- Requires assistance in daily activities
- Informal caregiver providing care (unpaid, typically a family member such as a spouse or child)
- Caregiver has sufficient proficiency in Turkish to understand and respond to the study questions
Who cannot join
- Presence of any additional neurodegenerative disease other than Parkinson's disease
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Advanced heart failure classified as New York Heart Association (NYHA) Class IV (symptoms at rest)
- Active cancer disease
- History of stroke causing limitations in daily life
- Immobility due to reasons other than Parkinson's disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beylikdüzü State Hospital
Istanbul, Beylikdüzü, 34147
Büşra Şirin, 02124443322, bsrn080@gmail.com
Büşra Şirin Ahısha, MD
About this study
Official title: Caregiver Burden and Associated Factors in Parkinson's Disease
Primary caregivers of patients diagnosed with idiopathic Parkinson's disease will be included in the study. A total of 43 participants will be recruited. At the beginning of the study, demographic data and clinical characteristics of the patients, including disease stage, history of falls, presence of fractures, presence and severity of pain, comorbidities, and medication use, will be recorded.
Subsequently, caregivers' age, gender, occupation, relationship to the patient, caregiving duration, and their own comorbidities will be assessed. Sleep problems will be evaluated using the Insomnia Severity Index (ISI), while symptoms related to depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be examined using the Zarit Caregiver Burden Scale.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiver Burden Scale
A scale used to assess the physical, emotional, and social burden of caregiving, with higher scores indicating greater caregiver burden. Score range: 0-88.
Measured: Baseline
Secondary outcomes (5)
Insomnia Severity Index (ISI)
A scale used to evaluate the severity of sleep problems in caregivers, with higher scores reflecting more severe insomnia. Score range: 0-28.
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)- Anxiety score
A tool used to assess symptoms of anxiety in caregivers. Higher scores indicate more severe anxiety. Score range: 0-21.
Measured: Baseline
Hoehn and Yahr Scale
A classification system used to determine the disease stage of Parkinson's disease, with higher stages indicating more severe disease progression. Score range: 1-5.
Measured: Baseline
Visual Analog Scale (VAS)
A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.
Measured: Baseline
Hospital Anxiety and Depression Scale (HADS)- Depression score
A tool used to assess symptoms of depression in caregivers. Higher scores indicate more severe depressive symptoms. Score range: 0-21.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start10 Feb 2025
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 43 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Beylikduzu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Sirin, Beylikduzu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892717
- Sponsor's protocol ID
- BeylikduzuStateH16
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden and Associated Factors in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06892717
- Acronym / sponsor ID
- BeylikduzuStateH16
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Beylikduzu State HospitalUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary caregivers of patients diagnosed with idiopathic Parkinson's disease will be included in the study. A total of 43 participants will be recruited. At the beginning of the study, demographic data and clinical characteristics of the patients, including disease stage, history of falls, presence of fractures, presence and severity of pain, comorbidities, and medication use, will be recorded.
Subsequently, caregivers' age, gender, occupation, relationship to the patient, caregiving duration, and their own comorbidities will be assessed. Sleep problems will be evaluated using the Insomnia Severity Index (ISI), while symptoms related to depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be examined using the Zarit Caregiver Burden Scale.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of caregivers of patients diagnosed with Parkinson's disease, aged between 40-80 years, who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- Age between 40-80 years
- Diagnosed with Parkinson's disease, Hoehn and Yahr stage 2-5
- Requires assistance in daily activities
- Informal caregiver providing care (unpaid, typically a family member such as a spouse or child)
- Caregiver has sufficient proficiency in Turkish to understand and respond to the study questions
Key exclusion criteria (6 listed)
- Presence of any additional neurodegenerative disease other than Parkinson's disease
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Advanced heart failure classified as New York Heart Association (NYHA) Class IV (symptoms at rest)
- Active cancer disease
- History of stroke causing limitations in daily life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
Zarit Caregiver Burden Scale
Time frame: Baseline
A scale used to assess the physical, emotional, and social burden of caregiving, with higher scores indicating greater caregiver burden. Score range: 0-88.
5 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)- Anxiety score
Time frame: Baseline
Hoehn and Yahr Scale
Time frame: Baseline
Visual Analog Scale (VAS)
Time frame: Baseline
Hospital Anxiety and Depression Scale (HADS)- Depression score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Beylikduzu State Hospital at 1 site 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zarit Caregiver Burden Scale (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.