Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT06443268
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebrovascular Disease: Quality of Life (CODE: QoL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D000182', 'term': 'ACTH Syndrome, Ectopic'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009384', 'term': 'Paraneoplastic Endocrine Syndromes'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Hair samples, routine blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 680}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-29', 'studyFirstSubmitDate': '2024-05-04', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'description': 'will be assessed using Short Form - 36 (SF-36)\n\nMulti-item scale with 8 domains assessing health related quality of life:\n\n* limitations in physical activities\n* limitations in social activities\n* limitations in usual role activities because\n* pain\n* limitations in social role activities\n* vitality\n* overall mental health\n* overall health\n\nDomains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations'}], 'secondaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'as assessed using Perceived Stress Scale - 10 (PSS-10)\n\nScoring is based on 2 subscales:\n\nSubscale 1: Perceived self-efficacy (PSE), range: (4-20)\n\nSubscale 2: Perceived helplessness (PH), range: (6-30)\n\nTotal score PSS-10 is evaluated by adding both sub scale scores.\n\nValues span from 10 to 50, higher values indicate higher levels of stress'}, {'measure': 'Positive Aspects of Caregiving:', 'timeFrame': 'caregivers at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Measure of caregiver burden\n\nQuestionnaire: 11 items / Likert scales (1-5)\n\nValues span from 11 to 55, higher values indicate positive aspects of caregiving'}, {'measure': 'Zarit Burden Interview:', 'timeFrame': 'caregivers at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Measure of caregiver burden\n\n22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burden'}, {'measure': 'Stroke Related Quality of Life', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using Stroke Impact Scale 3.0 (SIS-3.0)\n\nSIS-3.0 includes 60 items and assesses 9 domains using Likert scales:\n\n* Strength - 4 items\n* Hand function - 5 items\n* Activities of daily living - 10 items\n* Mobility - 9 items\n* Communication - 7 items\n* Emotion - 9 items\n* Memory and thinking - 7 items\n* Participation/Role function - 8 items\n* Perceived recovery since stroke onset - single-item VAS (visual analog scale)\n\nDomains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations'}, {'measure': 'Anxiety', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using General Anxiety Disorder- (GAD-7)\n\n7 items / Likert scales (0-3) Values span from 0 to 21, higher values indicate higher level of anxiety and functional impairment'}, {'measure': 'Depression', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using Patient Health Questionnaire - 9 (PHQ-9)\n\n9 items, evaluated by likert scale (0-3) Values span from 0 to 27, higher values indicate higher probability of depression and decreased functional status'}, {'measure': 'Sexual Quality of Life', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using Sexual Behavior Questionnaire German (SBQ-G)\n\nEqual base questions (1-6) and gender specific questions m(7-11), f(7-10)\n\nSingle item evaluation with two answer categories\n\n(0-1) dysfunctional (2-3) functional\n\nEvaluation of MGISD (Mean Global Index of sexual Dysfunction): Arithmetic mean of 1,4,5,6,8f/11m'}, {'measure': 'Incontinence', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using International Consultation on Incontinence Questionnaire (ICIQ)\n\n3 Questions regarding urinary incontinence\n\n* Frequency?\n* Severity?\n* Impact on quality of life?\n\nScore is sum of answer values (1 + 2 + 3); Range: 0-21\n\nScoring Categories\n\n* slight (1-5)\n* moderate (6-12)\n* severe (13-18)\n* very severe (19-21)'}, {'measure': 'neurological functioning of the patients (NIHSS)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using National Institutes of Health Stroke Scale (NIHSS)\n\nNIHSS\n\n* 13 assessed functional domains\n* Range 0-42, higher score indicates severe impairment'}, {'measure': 'neurological functioning of the patients (mRS)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using modified Rankin Scale (mRS)\n\nmRS\n\n• Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment'}, {'measure': 'neurological functioning of the patients (Barthel Index)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using Barthel Index\n\nBarthel Index\n\n* Physical impairment in daily life / self-care\n* score ranges from 0-100\n* higher score indicates fewer limitations'}, {'measure': 'Distress', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using Distress Thermometer\n\nAssessment with Visual Analog Scale (0-10), higher scale indicates more distress.\n\nSelection of aspects in life causing distress'}, {'measure': 'Quality of Life (short)', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using EuroQol-5 (EQ5-DL)\n\nEvaluation of 5 different aspects of health with likert scale (1-5)\n\n* MOBILITY\n* SELF-CARE\n* USUAL ACTIVITIES\n* PAIN / DISCOMFORT\n* ANXIETY / DEPRESSION\n\nEach domain is scored individually, higher values indicate higher impairment of quality of life'}, {'measure': 'Quality of Life (short)', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'will be assessed using EuroQol-5 (EQ5-DL)\n\nVisual analog scale:\n\nEQ VAS 0-100, higher score indicates better perceived current health'}, {'measure': 'cortisol / cortisone in hair (pg/mg)', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}, {'measure': 'fasting glucose (mmol/l)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}, {'measure': 'HbA1c (in %)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}, {'measure': 'Lipid profiles (LDL, HDL, triglycerides in mmol/l)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}, {'measure': 'TSH (mU/l)', 'timeFrame': 'patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}, {'measure': 'Blood pressure (systolic & diastolic in mmHg)', 'timeFrame': 'caregivers and patients at 0, 3 and 12 months after cerebrovascular event.', 'description': 'Stress biomarkers'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden'], 'conditions': ['Quality of Life', 'Stroke, Acute', 'Sexual Behavior', 'Stress', 'Cortisol Excess', 'Incontinence, Urinary', 'Caregiver Burden', 'Transient Ischemic Attack', 'Intracerebral Hemorrhage', 'Cerebrovascular Disorders']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '27783737', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27671537', 'type': 'BACKGROUND', 'citation': 'Zhang 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.'}, {'pmid': '26123859', 'type': 'BACKGROUND', 'citation': 'Jeong 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.'}, {'pmid': '25740862', 'type': 'BACKGROUND', 'citation': 'Haley 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.'}, {'pmid': '35661347', 'type': 'BACKGROUND', 'citation': 'Hansel 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.'}, {'pmid': '28629351', 'type': 'BACKGROUND', 'citation': 'Schmick 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.'}, {'pmid': '33220140', 'type': 'BACKGROUND', 'citation': 'Hamann 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.'}, {'pmid': '2749846', 'type': 'BACKGROUND', 'citation': 'Brott 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.'}, {'pmid': '3363593', 'type': 'BACKGROUND', 'citation': 'van 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.'}, {'pmid': '14258950', 'type': 'BACKGROUND', 'citation': 'MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.'}, {'pmid': '17453683', 'type': 'BACKGROUND', 'citation': 'Muller 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.'}, {'pmid': '13638508', 'type': 'BACKGROUND', 'citation': 'HAMILTON 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.'}, {'pmid': '11556941', 'type': 'BACKGROUND', 'citation': 'Kroenke 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.'}, {'pmid': '28627220', 'type': 'BACKGROUND', 'citation': 'Reis 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.'}, {'pmid': '24510195', 'type': 'BACKGROUND', 'citation': 'Ma X, Zhang J, Zhong W, Shu C, Wang F, Wen J, Zhou M, Sang Y, Jiang Y, Liu L. The diagnostic role of a short screening tool--the distress thermometer: a meta-analysis. Support Care Cancer. 2014 Jul;22(7):1741-55. doi: 10.1007/s00520-014-2143-1. Epub 2014 Feb 8.'}, {'pmid': '8560303', 'type': 'BACKGROUND', 'citation': 'Bullinger M. German translation and psychometric testing of the SF-36 Health Survey: preliminary results from the IQOLA Project. International Quality of Life Assessment. Soc Sci Med. 1995 Nov;41(10):1359-66. doi: 10.1016/0277-9536(95)00115-n.'}, {'pmid': '15227649', 'type': 'BACKGROUND', 'citation': 'Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.'}, {'pmid': '22150070', 'type': 'BACKGROUND', 'citation': 'Sharpley CF, McFarlane JR, Slominski A. Stress-linked cortisol concentrations in hair: what we know and what we need to know. Rev Neurosci. 2011 Dec 8;23(1):111-21. doi: 10.1515/RNS.2011.058.'}, {'pmid': '19027446', 'type': 'BACKGROUND', 'citation': 'Kim JH, Kim O. Influence of mastery and sexual frequency on depression in Korean men after a stroke. J Psychosom Res. 2008 Dec;65(6):565-9. doi: 10.1016/j.jpsychores.2008.06.005. Epub 2008 Oct 28.'}, {'pmid': '27548503', 'type': 'BACKGROUND', 'citation': 'Oyewole OO, Ogunlana MO, Gbiri CAO, Oritogun KS. Prevalence and impact of disability and sexual dysfunction on Health-Related Quality of Life of Nigerian stroke survivors. Disabil Rehabil. 2017 Oct;39(20):2081-2086. doi: 10.1080/09638288.2016.1219395. Epub 2016 Aug 22.'}, {'pmid': '15074432', 'type': 'BACKGROUND', 'citation': 'Forsberg-Warleby G, Moller A, Blomstrand C. Life satisfaction in spouses of patients with stroke during the first year after stroke. J Rehabil Med. 2004 Jan;36(1):4-11. doi: 10.1080/16501970310015191.'}, {'pmid': '25955112', 'type': 'BACKGROUND', 'citation': 'Kjork E, Blomstrand C, Carlsson G, Lundgren-Nilsson A, Gustafsson C. Daily life consequences, cognitive impairment, and fatigue after transient ischemic attack. Acta Neurol Scand. 2016 Feb;133(2):103-110. doi: 10.1111/ane.12435. Epub 2015 May 8.'}, {'pmid': '28088111', 'type': 'BACKGROUND', 'citation': 'Hinz A, Klein AM, Brahler E, Glaesmer H, Luck T, Riedel-Heller SG, Wirkner K, Hilbert A. Psychometric evaluation of the Generalized Anxiety Disorder Screener GAD-7, based on a large German general population sample. J Affect Disord. 2017 Mar 1;210:338-344. doi: 10.1016/j.jad.2016.12.012. Epub 2016 Dec 18.'}, {'type': 'BACKGROUND', 'citation': "Tarlow, B. J., Wisniewski, S. R., Belle, S. H., Rubert, M., Ory, M. G., & Gallagher-Thompson, D. (2004). Positive Aspects of Caregiving: Contributions of the REACH Project to the Development of New Measures for Alzheimer's Caregiving. Research on Aging, 26(4), 429-453. https://doi.org/10.1177/0164027504264493"}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn about quality of life, stress and caregiver burden in patients with stroke and their caregivers.\n\nThe main question is:\n\n• to discover the factors associated with quality of life and stress in patient-caregiver dyads.\n\nParticipants 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.\n\nResearchers will compare a group of participants without stroke to establish a comparable baseline.', 'detailedDescription': "Introduction/Background\n\nIn 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.\n\nAims and significance of the project\n\nThe 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.\n\nMethods\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Control group:\n\nWe 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).\n\nMain group:\n\nWe 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)', 'healthyVolunteers': True, 'eligibilityCriteria': "Control group:\n\nInclusion criteria:\n\n* over 18 years old\n* No previous stroke OR previous stroke \\>3 years ago\n* No significant disability (maximum mRS 1)\n* ambulatory patients at the University Hospital of Zurich (USZ), Dept. of Neurology\n* Patients' AND caregiver's ability to give informed consent\n* Patients' AND close relative's / caregiver's willingness to participate\n\nExclusion criteria:\n\n• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months\n\nMain Group:\n\nInclusion criteria:\n\n* over 18 years old\n* Patients diagnosed with either transient ischemic attack, ischemic stroke or intracerebral hemorrhage and their caregivers\n* Caregiver of a patient as described above, age over 18 years\n* Hospitalized or ambulatory patients at the University Hospital of Zurich (USZ) included within 28 days from event.\n* Patients' AND caregiver's ability to give informed consent\n* Patients' AND caregiver's willingness to participate\n\nExclusion criteria:\n\n• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months"}, 'identificationModule': {'nctId': 'NCT06443268', 'acronym': 'CODE:QoL', 'briefTitle': 'Cerebrovascular Disease: Quality of Life (CODE: QoL)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Cerebrovascular Disease: Quality of Life (CODE: QoL)', 'orgStudyIdInfo': {'id': '2023-00224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage', 'description': 'Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage', 'interventionNames': ['Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam']}, {'label': 'Caregivers of patients described above', 'description': 'Caregivers of patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage', 'interventionNames': ['Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam']}, {'label': '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', 'interventionNames': ['Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam']}, {'label': 'Caregivers of patients above', 'description': 'may include close relatives', 'interventionNames': ['Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam']}], 'interventions': [{'name': 'questionnaire, hair samples, blood samples, clinical exam', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Anton Schmick, MD', 'role': 'CONTACT', 'email': 'anton.schmick@usz.ch'}, {'name': 'Susanne Wegener, MD', 'role': 'CONTACT', 'email': 'susanne.wegener@usz.ch'}, {'name': 'Schmick Anton, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Neurology, University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Anton Schmick, MD', 'role': 'CONTACT', 'email': 'anton.schmick@usz.ch', 'phone': '+41442551111'}, {'name': 'Susanne Wegener, MD', 'role': 'CONTACT', 'email': 'susanne.wegener@usz.ch', 'phone': '+41442551111'}], 'overallOfficials': [{'name': 'Susanne Wegener, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'not planned at the time of register entry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Susanne Wegener', 'investigatorAffiliation': 'University of Zurich'}}}}