Menu
Recruiting NCT06892717

Caregiver Burden in Parkinson's Disease

Observational Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Caregiver Burden and Associated Factors in Parkinson's Disease

Overview

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.

Interventions

  • Other

Primary outcome measures

  • Zarit Caregiver Burden Scale [Time frame: Baseline]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • Beylikdüzü State Hospital — Istanbul

Identifiers

NCT: NCT06892717 · BeylikduzuStateH16

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗