Quality of LifeCODE:QoLNCT06443268
Cerebrovascular Disease: Quality of Life (CODE: QoL)
An observational study of Quality of Life and Stroke, Acute, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, Stroke, Acute, Sexual Behavior
- What is being tested?
- questionnaire, hair samples, blood samples, clinical exam
- How many people
- 680 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 May 2023to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
- Main Group:
- Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Zurich
Zurich, Canton of Zurich, 8091
Anton Schmick, MD, anton.schmick@usz.ch
Susanne Wegener, MD, susanne.wegener@usz.ch
About this study
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.
Read the 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.
- Conditions
- Quality of Life, Stroke, Acute, Sexual Behavior, Stress, Cortisol Excess, Incontinence, Urinary
- Being tested
- questionnaire, hair samples, blood samples, clinical exam
- Keywords
- Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden
- Medical subject headings
- Stroke, Sexual Behavior, ACTH Syndrome, Ectopic, Urinary Incontinence, Caregiver Burden, Ischemic Attack, Transient, Cerebral Hemorrhage, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire, hair samples, blood samples, clinical examDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage | Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage Receives: Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam | |
| Caregivers of patients described above | Caregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage Receives: Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam | |
| Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage | Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage or with an event > 3 years ago AND no disability Receives: Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam | |
| Caregivers of patients above | may include close relatives Receives: Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality 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
Measured: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
cortisol / cortisone in hair (pg/mg)
Stress biomarkers
Measured: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
fasting glucose (mmol/l)
Stress biomarkers
Measured: patients at 0, 3 and 12 months after cerebrovascular event.
HbA1c (in %)
Stress biomarkers
Measured: patients at 0, 3 and 12 months after cerebrovascular event.
Lipid profiles (LDL, HDL, triglycerides in mmol/l)
Stress biomarkers
Measured: patients at 0, 3 and 12 months after cerebrovascular event.
TSH (mU/l)
Stress biomarkers
Measured: patients at 0, 3 and 12 months after cerebrovascular event.
Blood pressure (systolic & diastolic in mmHg)
Stress biomarkers
Measured: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start27 May 2023
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanne Wegener, University of Zurich
- Investigators
- Susanne Wegener, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443268
- Sponsor's protocol ID
- 2023-00224
- Other IDs
- 2023
- Acronym
- CODE:QoL
- Status last verified
- May 2024
- First submitted
- 4 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not planned at the time of register entry
Publications
Bundesamt für Statistik. Herz und Kreislauf Erkrankungen [online; visited: 21.11.2022] https://www.bfs.admin.ch/bfs/de/home/statistiken/gesundheit/gesundheitszustand/krankheiten/herz-kreislauf-erkrankungen.html
Costa TF, Gomes TM, Viana LR, Martins KP, Costa KN. Stroke: patient characteristics and quality of life of caregivers. Rev Bras Enferm. 2016 Sep-Oct;69(5):933-939. doi: 10.1590/0034-7167-2015-0064. English, Portuguese.
PubMed 27783737Zhang J, Lee DT. Meaning in stroke family caregiving: A literature review. Geriatr Nurs. 2017 Jan-Feb;38(1):48-56. doi: 10.1016/j.gerinurse.2016.07.005. Epub 2016 Sep 23.
PubMed 27671537Jeong YG, Myong JP, Koo JW. The modifying role of caregiver burden on predictors of quality of life of caregivers of hospitalized chronic stroke patients. Disabil Health J. 2015 Oct;8(4):619-25. doi: 10.1016/j.dhjo.2015.05.005. Epub 2015 May 29.
PubMed 26123859Haley WE, Roth DL, Hovater M, Clay OJ. Long-term impact of stroke on family caregiver well-being: a population-based case-control study. Neurology. 2015 Mar 31;84(13):1323-9. doi: 10.1212/WNL.0000000000001418. Epub 2015 Mar 4.
PubMed 25740862Hansel M, Steigmiller K, Luft AR, Gebhard C, Held U, Wegener S. Neurovascular disease in Switzerland: 10-year trends show non-traditional risk factors on the rise and higher exposure in women. Eur J Neurol. 2022 Sep;29(9):2851-2860. doi: 10.1111/ene.15434. Epub 2022 Jun 22.
PubMed 35661347Schmick A, Juergensen M, Rohde V, Katalinic A, Waldmann A. Assessing health-related quality of life in urology - a survey of 4500 German urologists. BMC Urol. 2017 Jun 19;17(1):46. doi: 10.1186/s12894-017-0235-1.
PubMed 28629351Hamann J, Herzog L, Wehrli C, Dobrocky T, Bink A, Piccirelli M, Panos L, Kaesmacher J, Fischer U, Stippich C, Luft AR, Gralla J, Arnold M, Wiest R, Sick B, Wegener S. Machine-learning-based outcome prediction in stroke patients with middle cerebral artery-M1 occlusions and early thrombectomy. Eur J Neurol. 2021 Apr;28(4):1234-1243. doi: 10.1111/ene.14651. Epub 2020 Dec 21.
PubMed 33220140Brott T, Adams HP Jr, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989 Jul;20(7):864-70. doi: 10.1161/01.str.20.7.864.
PubMed 2749846van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7. doi: 10.1161/01.str.19.5.604.
PubMed 3363593MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Muller MJ. Development and retest reliability of a German version of the Sexual Behaviour Questionnaire (SBQ-G). Arch Androl. 2007 Mar-Apr;53(2):67-9. doi: 10.1080/01485010600915186.
PubMed 17453683HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
PubMed 13638508Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Reis D, Lehr D, Heber E, Ebert DD. The German Version of the Perceived Stress Scale (PSS-10): Evaluation of Dimensionality, Validity, and Measurement Invariance With Exploratory and Confirmatory Bifactor Modeling. Assessment. 2019 Oct;26(7):1246-1259. doi: 10.1177/1073191117715731. Epub 2017 Jun 18.
PubMed 28627220
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Disease: Quality of Life (CODE: QoL)
- ClinicalTrials.gov ID
- NCT06443268
- Acronym / sponsor ID
- CODE:QoL / 2023-00224
- Conditions
- Quality of Life, Stroke, Acute, Sexual Behavior, Stress, Cortisol Excess, Incontinence, Urinary
- Keywords
- Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 680 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage | – | Diagnostic Test: questionnaire, hair samples, blood samples, clinical examPatients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage |
| Caregivers of patients described above | – | Diagnostic Test: questionnaire, hair samples, blood samples, clinical examCaregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage |
| Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage | – | Diagnostic Test: questionnaire, hair samples, blood samples, clinical examPatients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage or with an event > 3 years ago AND no disability |
| Caregivers of patients above | – | Diagnostic Test: questionnaire, hair samples, blood samples, clinical exammay include close relatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
- Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire, hair samples, blood samples, clinical examThe 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. | Diagnostic test | Caregivers of patients above, Caregivers of patients described above, Patients WITHOUT ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage, Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage |
Primary outcome
Quality of Life as assessed via Short Form - 36 (SF-36)
Time frame: 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
20 secondary outcomes
Stress
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Positive Aspects of Caregiving:
Time frame: caregivers at 0, 3 and 12 months after cerebrovascular event.
Zarit Burden Interview:
Time frame: caregivers at 0, 3 and 12 months after cerebrovascular event.
Stroke Related Quality of Life
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Anxiety
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Depression
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Sexual Quality of Life
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Incontinence
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (NIHSS)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (mRS)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
neurological functioning of the patients (Barthel Index)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Distress
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Quality of Life (short)
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Quality of Life (short)
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
cortisol / cortisone in hair (pg/mg)
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
fasting glucose (mmol/l)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
HbA1c (in %)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Lipid profiles (LDL, HDL, triglycerides in mmol/l)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
TSH (mU/l)
Time frame: patients at 0, 3 and 12 months after cerebrovascular event.
Blood pressure (systolic & diastolic in mmHg)
Time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- BackgroundBundesamt für Statistik. Herz und Kreislauf Erkrankungen [online; visited: 21.11.2022] https://www.bfs.admin.ch/bfs/de/home/statistiken/gesundheit/gesundheitszustand/krankheiten/herz-kreislauf-erkrankungen.html
- Background: PubMed 27783737Costa TF, Gomes TM, Viana LR, Martins KP, Costa KN. Stroke: patient characteristics and quality of life of caregivers. Rev Bras Enferm. 2016 Sep-Oct;69(5):933-939. doi: 10.1590/0034-7167-2015-0064. English, Portuguese.
- Background: PubMed 27671537Zhang J, Lee DT. Meaning in stroke family caregiving: A literature review. Geriatr Nurs. 2017 Jan-Feb;38(1):48-56. doi: 10.1016/j.gerinurse.2016.07.005. Epub 2016 Sep 23.
- Background: PubMed 26123859Jeong YG, Myong JP, Koo JW. The modifying role of caregiver burden on predictors of quality of life of caregivers of hospitalized chronic stroke patients. Disabil Health J. 2015 Oct;8(4):619-25. doi: 10.1016/j.dhjo.2015.05.005. Epub 2015 May 29.
- Background: PubMed 25740862Haley WE, Roth DL, Hovater M, Clay OJ. Long-term impact of stroke on family caregiver well-being: a population-based case-control study. Neurology. 2015 Mar 31;84(13):1323-9. doi: 10.1212/WNL.0000000000001418. Epub 2015 Mar 4.
- Background: PubMed 35661347Hansel M, Steigmiller K, Luft AR, Gebhard C, Held U, Wegener S. Neurovascular disease in Switzerland: 10-year trends show non-traditional risk factors on the rise and higher exposure in women. Eur J Neurol. 2022 Sep;29(9):2851-2860. doi: 10.1111/ene.15434. Epub 2022 Jun 22.
- Background: PubMed 28629351Schmick A, Juergensen M, Rohde V, Katalinic A, Waldmann A. Assessing health-related quality of life in urology - a survey of 4500 German urologists. BMC Urol. 2017 Jun 19;17(1):46. doi: 10.1186/s12894-017-0235-1.
- Background: PubMed 33220140Hamann J, Herzog L, Wehrli C, Dobrocky T, Bink A, Piccirelli M, Panos L, Kaesmacher J, Fischer U, Stippich C, Luft AR, Gralla J, Arnold M, Wiest R, Sick B, Wegener S. Machine-learning-based outcome prediction in stroke patients with middle cerebral artery-M1 occlusions and early thrombectomy. Eur J Neurol. 2021 Apr;28(4):1234-1243. doi: 10.1111/ene.14651. Epub 2020 Dec 21.
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- Background: PubMed 17453683Muller MJ. Development and retest reliability of a German version of the Sexual Behaviour Questionnaire (SBQ-G). Arch Androl. 2007 Mar-Apr;53(2):67-9. doi: 10.1080/01485010600915186.
- Individual participant dataSharing planned: No. not planned at the time of register entry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Wegener, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Stroke, Acute, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anton Schmick, MD (+41442551111, anton.schmick@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life as assessed via Short Form - 36 (SF-36) (time frame: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443268, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.