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.
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.
Study Type
OBSERVATIONAL
Enrollment
680
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.
Department of Neurology, University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
RECRUITINGQuality of Life as assessed via Short Form - 36 (SF-36)
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
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Stress
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 stress
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Positive Aspects of Caregiving:
Measure of caregiver burden Questionnaire: 11 items / Likert scales (1-5) Values span from 11 to 55, higher values indicate positive aspects of caregiving
Time frame: caregivers at 0, 3 and 12 months after cerebrovascular event.
Zarit Burden Interview:
Measure of caregiver burden 22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burden
Time frame: caregivers at 0, 3 and 12 months after cerebrovascular event.
Stroke Related Quality of Life
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 limitations
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Anxiety
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 impairment
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Depression
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 status
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Sexual Quality of Life
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/11m
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Incontinence
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)
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (NIHSS)
will be assessed using National Institutes of Health Stroke Scale (NIHSS) NIHSS * 13 assessed functional domains * Range 0-42, higher score indicates severe impairment
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (mRS)
will be assessed using modified Rankin Scale (mRS) mRS • Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (Barthel Index)
will be assessed using Barthel Index Barthel Index * Physical impairment in daily life / self-care * score ranges from 0-100 * higher score indicates fewer limitations
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Distress
will be assessed using Distress Thermometer Assessment with Visual Analog Scale (0-10), higher scale indicates more distress. Selection of aspects in life causing distress
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Quality of Life (short)
will be assessed using EuroQol-5 (EQ5-DL) Evaluation of 5 different aspects of health with likert scale (1-5) * MOBILITY * SELF-CARE * USUAL ACTIVITIES * PAIN / DISCOMFORT * ANXIETY / DEPRESSION Each domain is scored individually, higher values indicate higher impairment of quality of life
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Quality of Life (short)
will be assessed using EuroQol-5 (EQ5-DL) Visual analog scale: EQ VAS 0-100, higher score indicates better perceived current health
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
cortisol / cortisone in hair (pg/mg)
Stress biomarkers
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
fasting glucose (mmol/l)
Stress biomarkers
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
HbA1c (in %)
Stress biomarkers
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Lipid profiles (LDL, HDL, triglycerides in mmol/l)
Stress biomarkers
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
TSH (mU/l)
Stress biomarkers
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Blood pressure (systolic & diastolic in mmHg)
Stress biomarkers
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
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