questionnaire, hair samples, blood samples, clinical exam: The following parameters will be sequentially assessed in caregivers and patients (baseline, at 3 months and at 12 months): 1) quality of life / functioning will be determined through questionnaires (SF-36, EQ-5DL, ECOG (Eastern Cooperative Oncology Group) / Karnofsky, Barthel Index, ICIQ) 2) stress levels \& anxiety levels, caregiver burden will be assessed by the following questionnaires: Distress Thermometer, SBQ-G, GAD-7, PHQ-9, PSS-10, ZBI, PAC. Cortisol will be measured in hair to indicate stress within the past 3 months \[18\]. Fasting glucose, lipid profiles and HbA1c along with blood count, sodium, potassium, creatinine, TSH (thyroid-stimulating hormone) will be measured in routine blood samples from patients at the time of clinical checkups. Blood pressure, pulse and BMI will be determined during clinical visit in patients and additionally in caregivers.
Study summary
The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers.
The main question is:
• to discover the factors associated with quality of life and stress in patient-caregiver dyads.
Participants will be asked to fill out questionnaires and agree to provide a hair sample (in order to measure stress hormones in hair) and consent to use of their routine clinical and laboratory data.
Researchers will compare a group of participants without stroke to establish a comparable baseline.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Control group:
Inclusion criteria:
* over 18 years old
* No previous stroke OR previous stroke \>3 years ago
* No significant disability (maximum mRS 1)
* ambulatory patients at the University Hospital of Zurich (USZ), Dept. of Neurology
* Patients' AND caregiver's ability to give informed consent
* Patients' AND close relative's / caregiver's willingness to participate
Exclusion criteria:
• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Main Group:
Inclusion criteria:
* over 18 years old
* Patients diagnosed with either transient ischemic attack, ischemic stroke or intracerebral hemorrhage and their caregivers
* Caregiver of a patient as described above, age over 18 years
* Hospitalized or ambulatory patients at the University Hospital of Zurich (USZ) included within 28 days from event.
* Patients' AND caregiver's ability to give informed consent
* Patients' AND caregiver's willingness to participate
Exclusion criteria:
• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Primary outcome measure(s)
Quality of Life as assessed via Short Form - 36 (SF-36) — caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Short Form - 36 (SF-36)
Multi-item scale with 8 domains assessing health related quality of life:
* limitations in physical activities
* limitations in social activities
* limitations in usual role activities because
* pain
* limitations in social role activities
* vitality
* overall mental health
* overall health
Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations
Trial sites (1)
Facility
City
Region
Status
Department of Neurology, University Hospital Zurich
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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