The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke
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: Stroke. 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 and Insomnia Severity and Caregiver Burden in Caregivers of Stroke Patients
Overview
This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Patients' functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index, while ambulation status will be documented with the Holden Scale. Caregivers will complete the Insomnia Severity Index to assess the severity of sleep disturbances and the Hospital Anxiety and Depression Scale to evaluate anxiety and depressive symptoms. Caregiver burden will be measured using the Zarit Caregiver Burden Scale. The study aims to investigate the relationship between caregivers' mood, insomnia severity, and caregiver burden.
Interventions
- Other no intervention
no intervention
Primary outcome measures
- Zarit Caregiver Burden Scale (ZCBS) [Time frame: Baseline]
Secondary outcome measures (6)
- 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]
- Modified Rankin Scale (mRS) [Time frame: Baseline]
- Modified Barthel Index (MBI) [Time frame: Baseline]
- Holden Functional Ambulation Classification (FAC) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Age 18-80 years.
- Clinical diagnosis of stroke (ischemic or hemorrhagic; first-ever or recurrent).
- Ability of both the patient and caregiver to communicate in Turkish and participate in evaluations (mRS, Brunnstrom, Modified Barthel Index, Holden).
- Caregiver must have been the primary caregiver for the patient for at least 1 month.
- Willingness of both the patient and caregiver to participate in the study.
Exclusion criteria
- History of subarachnoid hemorrhage.
- Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
- Terminal illness (life expectancy < 6 months).
- Inability to reliably complete questionnaires due to a psychiatric disorder.
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 Rehabilitation Training and Research Hospital — Istanbul
Identifiers
NCT: NCT07253519 · istftrrrr