Cerebrovascular Disease: Quality of Life (CODE: QoL) (CODE:QoL)

University of Zurich (UZH)

Status: Enrolling

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

Treatments: Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Study type: Observational

Funder types: Other

Identifiers

NCT06443268

2023-00224

Details and patient eligibility

About

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.

Full description

Introduction/Background

In Switzerland, approximately 21,000 people suffer a stroke each year. Stroke causes neurological impairments for those affected and brings about a sudden change in their life situation. The relatives of stroke patients receive new social roles and are challenged in a new way by the morbidity of the affected person, leading to a change in their quality of life and aggravation of stress. Unlike chronic diseases, a stroke occurs suddenly, so relatives have no opportunity to gradually adapt to the new living circumstances or to deal with the new psychosocial roles and demands beforehand. To what extent the daily life of patients and their relatives changes and what impact this has on their quality of life and stress has not been systematically investigated in Switzerland thus far.

Aims and significance of the project

The aim of the project is to systematically assess the quality of life and stress, as well as to capture stress biomarkers in stroke patients and their relatives. The investigators plan to conduct sequential measurements of quality of life and stress hormones at multiple time points over 12 months. The goal is in particular to uncover the relationships between the extent of patients' impairments, their quality of life, and stress in affected individuals and their relatives. This is a first-time project with the goal of learning more about stressors and biological relationships. This will create the basis for a multimodal intervention to improve the quality of life of those affected and their relatives, which will be investigated in a follow-up project.

Methods

The Investigators plan a prospective study with a survey of stroke patients and their relatives regarding their quality of life in everyday life. It will also be examined, how multiple stress biomarkers (which will be determined in blood and hair) are related to quality of life and stress and which clinical factors have a positive and negative influence on the well-being of patients and their relatives.

Enrollment: 680 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

680 participants in 4 patient groups

Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

Description:

Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

Treatment:

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Caregivers of patients described above

Description:

Caregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

Treatment:

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

Description:

Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage or with an event \> 3 years ago AND no disability

Treatment:

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Caregivers of patients above

Description:

may include close relatives

Treatment:

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam