Clinical trial NCT06443268: Cerebrovascular Disease: Quality of Life (CODE: QoL)
Official title: Cerebrovascular Disease: Quality of Life (CODE: QoL)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Quality of Life
Stroke, Acute
Sexual Behavior
Stress
Cortisol Excess
Incontinence, Urinary
Caregiver Burden
Transient Ischemic Attack
Intracerebral Hemorrhage
Cerebrovascular Disorders
Keywords: Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 680
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Control group:

We will include 40 patients without previous stroke OR patients with a minor stroke \> 3 years ago and no sustained significant disability (mRS 0 or 1) along with their close relative (to simulate informal caregivers) (total 80 participants).

Main group:

We will include 300 patients and informal caregivers with a first cerebrovascular event treated at our clinic \> 18 years. The caregivers will be defined as the closest person to the patient with the most contact. (total 600 participants)

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Quality of Life as assessed via Short Form - 36 (SF-36)
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary outcomes:
measure: Stress
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Positive Aspects of Caregiving:
timeFrame: caregivers at 0, 3 and 12 months after cerebrovascular event.
measure: Zarit Burden Interview:
timeFrame: caregivers at 0, 3 and 12 months after cerebrovascular event.
measure: Stroke Related Quality of Life
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: Anxiety
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Depression
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Sexual Quality of Life
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Incontinence
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: neurological functioning of the patients (NIHSS)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: neurological functioning of the patients (mRS)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: neurological functioning of the patients (Barthel Index)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: Distress
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Quality of Life (short)
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: Quality of Life (short)
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: cortisol / cortisone in hair (pg/mg)
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
measure: fasting glucose (mmol/l)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: HbA1c (in %)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: Lipid profiles (LDL, HDL, triglycerides in mmol/l)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: TSH (mU/l)
timeFrame: patients at 0, 3 and 12 months after cerebrovascular event.
measure: Blood pressure (systolic & diastolic in mmHg)
timeFrame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Department of Neurology, University Hospital Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Susanne Wegener, MD
role: PRINCIPAL_INVESTIGATOR
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