Clinical trial · Observational
Cerebrovascular Disease: Quality of Life (CODE: QoL)
NCT06443268CI-TRIAL-00077745CODE:QoLrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caregiver Burden | — | UNRESOLVED | — |
| Cerebrovascular Disorders | — | UNRESOLVED | — |
| Cortisol Excess | — | UNRESOLVED | — |
| Incontinence, Urinary | — | UNRESOLVED | — |
| Intracerebral Hemorrhage | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Behavior | — | UNRESOLVED | — |
| Stress | — | UNRESOLVED | — |
| Stroke, Acute | — | UNRESOLVED | — |
| Transient Ischemic Attack | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire, hair samples, blood samples, clinical exam | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (25)
- 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
- BACKGROUNDCosta 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 27783737
- BACKGROUNDZhang 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 27671537
- BACKGROUNDJeong 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 26123859
- BACKGROUNDHaley 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 25740862
- BACKGROUNDHansel 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 35661347
- BACKGROUNDSchmick 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 28629351
- 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.