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

Plain Language Summary

Simplified for easier understanding

This study explores the quality of life of people who have had a stroke or are at risk of stroke — including how stroke affects daily functioning, emotional wellbeing, and what support caregivers need. Both patients and their close relatives or caregivers are involved. **You may be eligible if...** - You are over 18 years old - You are a patient at the University Hospital of Zurich Neurology Department - You either had a stroke more than 3 years ago (or never), with no significant disability - OR you have had a recent stroke (for the stroke group) - Your caregiver or close relative is also willing to participate **You may NOT be eligible if...** - You (or your caregiver) cannot give informed consent - You or your relative are not able or willing to participate - Your disability level is too severe for the control group criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

Department of Neurology, University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

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NCT06443268

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