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NCT Number: NCT06892717

Caregiver Burden 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.

Recruiting

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beylikdüzü State Hospital

Istanbul, Beylikdüzü, 34147, Turkey (Türkiye)

Location status: Recruiting

Location contact

Büşra Şirin

CONTACT

[email protected]

02124443322

Büşra Şirin Ahısha, MD

PRINCIPAL_INVESTIGATOR

Nurdan Paker, Prof

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline

    A scale used to evaluate the severity of sleep problems in caregivers, with higher scores reflecting more severe insomnia. Score range: 0-28.

  2. Hospital Anxiety and Depression Scale (HADS)- Anxiety score

    Time frame: Baseline

    A tool used to assess symptoms of anxiety in caregivers. Higher scores indicate more severe anxiety. Score range: 0-21.

  3. Hoehn and Yahr Scale

    Time frame: Baseline

    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.

  4. Visual Analog Scale (VAS)

    Time frame: Baseline

    A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.

  5. Hospital Anxiety and Depression Scale (HADS)- Depression score

    Time frame: Baseline

    A tool used to assess symptoms of depression in caregivers. Higher scores indicate more severe depressive symptoms. Score range: 0-21.

Sponsors and collaborators

Lead sponsor

Beylikduzu State Hospital

Other

Registry information

Official study title

Caregiver Burden and Associated Factors in Parkinson's Disease

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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