Caregiver Burden in Parkinson's Disease

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06892717
• Lead Sponsor: Beylikduzu State Hospital

Brief 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, 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-10
• Status Verified: 2025-03
• Study First Submitted: 2025-03-08
• Study First Submitted QC: 2025-03-22
• Last Update Submitted: 2025-03-22
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Zarit Caregiver Burden Scale	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 Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Baseline	A scale used to evaluate the severity of sleep problems in caregivers, with higher scores reflecting more severe insomnia. Score range: 0-28.
Hospital Anxiety and Depression Scale (HADS)- Anxiety score	Baseline	A tool used to assess symptoms of anxiety in caregivers. Higher scores indicate more severe anxiety. Score range: 0-21.
Hoehn and Yahr Scale	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.
Visual Analog Scale (VAS)	Baseline	A linear scale used to assess pain severity, where higher scores indicate more severe pain. Score range: 0-10.
Hospital Anxiety and Depression Scale (HADS)- Depression score	Baseline	A tool used to assess symptoms of depression in caregivers. Higher scores indicate more severe depressive symptoms. Score range: 0-21.

Trial Locations

Locations (1)

Beylikdüzü State Hospital; 🇹🇷 Istanbul, Beylikdüzü, Turkey