Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

NCT07549048 | Recruiting

• 1 other identifier: istftreah13
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI)

  Caregiver burden will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater caregiver burden.

  Baseline

Secondary Outcomes (5)

• Insomnia Severity Index (ISI)

  Baseline

• Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

  Baseline

• Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

  Baseline

• Expanded Disability Status Scale (EDSS)

  Baseline

• Multiple Sclerosis Impact Scale (MSIS)

  Baseline

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Multiple sclerosis and caregivers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital

Istanbul, Bahcelievler, 34100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 23, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): May 20, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

TU (1)