Caregiver Burden in Caregivers of Patients With Multiple Sclerosis
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
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis. Basic parameters: 18 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 →
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Official title
The Relationship Between Mood, Insomnia Severity, and Caregiver Burden in Caregivers of Patients With Multiple Sclerosis
Overview
Individuals aged 18-80 years who have been clinically diagnosed with multiple sclerosis and their caregivers will be included in the study. Demographic data of the patients, including age, height, weight, and comorbidities, will be recorded. Disease-specific characteristics such as disease duration, presence of incontinence, ambulation status, and presence and severity of pain will be assessed. Functional status of the patients will be evaluated using the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Impact Scale (MSIS). Symptoms related to depression and anxiety in patients will be assessed using the Hospital Anxiety and Depression Scale (HADS). Subsequently, caregivers of the patients will be evaluated. The severity of insomnia will be assessed using the Insomnia Severity Index (ISI). Symptoms related to anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be assessed using the Zarit Caregiver Burden Scale.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI) [Time frame: Baseline]
Secondary outcome measures (5)
- Insomnia Severity Index (ISI) [Time frame: Baseline]
- Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A) [Time frame: Baseline]
- Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D) [Time frame: Baseline]
- Expanded Disability Status Scale (EDSS) [Time frame: Baseline]
- Multiple Sclerosis Impact Scale (MSIS) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Age 18-80 years
- Clinically diagnosed with multiple sclerosis by a neurologist
- Being followed in the physical therapy and rehabilitation clinics during the study period
- Having a primary or regular caregiver (family member)
- Both patient and caregiver able to read and understand Turkish and complete questionnaires
- Willing to participate and provide written informed consent
Exclusion criteria
- Severe cognitive impairment or communication problems preventing questionnaire completion
- Acute relapse or hospitalization due to exacerbation within the last month
- Severe comorbid neurological, psychiatric, or systemic disease affecting assessments
- Caregiver <18 years old or not providing regular care
- Paid professional caregiver
- Caregiver with severe psychiatric, neurological, or primary sleep disorder
- Refusal to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital — Istanbul
Identifiers
NCT: NCT07549048 · istftreah13