RecruitingNCT06443268

Cerebrovascular Disease: Quality of Life (CODE: QoL)

Sponsor

University of Zurich

Enrollment

680 participants

Start Date

May 27, 2023

Study Type

OBSERVATIONAL

Conditions

Quality of Life Stress Caregiver Burden Cerebrovascular Disorders Stroke, Acute Sexual Behavior Cortisol Excess Incontinence, Urinary Transient Ischemic Attack Intracerebral Hemorrhage

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

Min Age: 18 Years

Inclusion Criteria13

Control group:
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
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 Criteria3

• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Main Group:
• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months

Interventions

DIAGNOSTIC_TESTquestionnaire, 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.