Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Multiple sclerosis and caregivers

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

Insomnia Severity Index (ISI)

The ISI evaluates the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia.

Time frame
Baseline
2

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

Scores range from 0 to 21, with higher scores indicating greater anxiety.

Time frame
Baseline
3

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

Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.

Time frame
Baseline
4

Expanded Disability Status Scale (EDSS)

The EDSS evaluates disability in multiple sclerosis patients, ranging from 0 (normal neurological exam) to 10 (death due to MS).

Time frame
Baseline

Other outcomes

Sponsors and contacts

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