Cerebrovascular Disease: Quality of Life (CODE: QoL)
- Conditions
- Intracerebral HemorrhageCortisol ExcessQuality of LifeSexual BehaviorTransient Ischemic AttackStroke, AcuteStressIncontinence, UrinaryCaregiver BurdenCerebrovascular Disorders
- Interventions
- Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam
- Registration Number
- NCT06443268
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 680
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage questionnaire, hair samples, blood samples, clinical exam Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage or with an event \> 3 years ago AND no disability Caregivers of patients above questionnaire, hair samples, blood samples, clinical exam may include close relatives Caregivers of patients described above questionnaire, hair samples, blood samples, clinical exam Caregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage questionnaire, hair samples, blood samples, clinical exam Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Stress caregivers and patients at 0, 3 and 12 months after cerebrovascular event. as assessed using Perceived Stress Scale - 10 (PSS-10)
Scoring is based on 2 subscales:
Subscale 1: Perceived self-efficacy (PSE), range: (4-20)
Subscale 2: Perceived helplessness (PH), range: (6-30)
Total score PSS-10 is evaluated by adding both sub scale scores.
Values span from 10 to 50, higher values indicate higher levels of stressSexual Quality of Life caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Sexual Behavior Questionnaire German (SBQ-G)
Equal base questions (1-6) and gender specific questions m(7-11), f(7-10)
Single item evaluation with two answer categories
(0-1) dysfunctional (2-3) functional
Evaluation of MGISD (Mean Global Index of sexual Dysfunction): Arithmetic mean of 1,4,5,6,8f/11mIncontinence caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using International Consultation on Incontinence Questionnaire (ICIQ)
3 Questions regarding urinary incontinence
* Frequency?
* Severity?
* Impact on quality of life?
Score is sum of answer values (1 + 2 + 3); Range: 0-21
Scoring Categories
* slight (1-5)
* moderate (6-12)
* severe (13-18)
* very severe (19-21)Positive Aspects of Caregiving: caregivers at 0, 3 and 12 months after cerebrovascular event. Measure of caregiver burden
Questionnaire: 11 items / Likert scales (1-5)
Values span from 11 to 55, higher values indicate positive aspects of caregivingStroke Related Quality of Life patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Stroke Impact Scale 3.0 (SIS-3.0)
SIS-3.0 includes 60 items and assesses 9 domains using Likert scales:
* Strength - 4 items
* Hand function - 5 items
* Activities of daily living - 10 items
* Mobility - 9 items
* Communication - 7 items
* Emotion - 9 items
* Memory and thinking - 7 items
* Participation/Role function - 8 items
* Perceived recovery since stroke onset - single-item VAS (visual analog scale)
Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitationsAnxiety caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using General Anxiety Disorder- (GAD-7)
7 items / Likert scales (0-3) Values span from 0 to 21, higher values indicate higher level of anxiety and functional impairmentDepression caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Patient Health Questionnaire - 9 (PHQ-9)
9 items, evaluated by likert scale (0-3) Values span from 0 to 27, higher values indicate higher probability of depression and decreased functional statusneurological functioning of the patients (mRS) patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using modified Rankin Scale (mRS)
mRS
• Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairmentDistress caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Distress Thermometer
Assessment with Visual Analog Scale (0-10), higher scale indicates more distress.
Selection of aspects in life causing distressQuality of Life (short) caregivers and patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using EuroQol-5 (EQ5-DL)
Visual analog scale:
EQ VAS 0-100, higher score indicates better perceived current healthcortisol / cortisone in hair (pg/mg) caregivers and patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
fasting glucose (mmol/l) patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
Blood pressure (systolic & diastolic in mmHg) caregivers and patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
Zarit Burden Interview: caregivers at 0, 3 and 12 months after cerebrovascular event. Measure of caregiver burden
22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burdenneurological functioning of the patients (NIHSS) patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using National Institutes of Health Stroke Scale (NIHSS)
NIHSS
* 13 assessed functional domains
* Range 0-42, higher score indicates severe impairmentneurological functioning of the patients (Barthel Index) patients at 0, 3 and 12 months after cerebrovascular event. will be assessed using Barthel Index
Barthel Index
* Physical impairment in daily life / self-care
* score ranges from 0-100
* higher score indicates fewer limitationsHbA1c (in %) patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
Lipid profiles (LDL, HDL, triglycerides in mmol/l) patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
TSH (mU/l) patients at 0, 3 and 12 months after cerebrovascular event. Stress biomarkers
Trial Locations
- Locations (1)
Department of Neurology, University Hospital Zurich
🇨🇭Zürich, Zurich, Switzerland