Cerebrovascular Disease: Quality of Life (CODE: QoL)

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест questionnaire, hair samples, blood samples, clinical exam
  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

Первичные конечные точки

• Quality of Life as assessed via Short Form - 36 (SF-36) [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]

Вторичные конечные точки (12)

• Stress [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]
• Positive Aspects of Caregiving: [Срок оценки: caregivers at 0, 3 and 12 months after cerebrovascular event.]
• Zarit Burden Interview: [Срок оценки: caregivers at 0, 3 and 12 months after cerebrovascular event.]
• Stroke Related Quality of Life [Срок оценки: patients at 0, 3 and 12 months after cerebrovascular event.]
• Anxiety [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]
• Depression [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]
• Sexual Quality of Life [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]
• Incontinence [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]
• neurological functioning of the patients (NIHSS) [Срок оценки: patients at 0, 3 and 12 months after cerebrovascular event.]
• neurological functioning of the patients (mRS) [Срок оценки: patients at 0, 3 and 12 months after cerebrovascular event.]
• neurological functioning of the patients (Barthel Index) [Срок оценки: patients at 0, 3 and 12 months after cerebrovascular event.]
• Distress [Срок оценки: caregivers and patients at 0, 3 and 12 months after cerebrovascular event.]

Критерии участия

Control group:

Критерии включения

• 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

Критерии исключения

• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months

Main Group:

Критерии включения

• 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

Критерии исключения

• Medication with steroid hormones (prednisone, prednisolone, dexamethasone, methylprednisolone, hydrocortisone etc.) within last 3 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Department of Neurology, University Hospital Zurich — Zurich

Публикации

• 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. PMID 27783737
• 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 27671537
• 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 26123859
• 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 25740862
• 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 35661347
• 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 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. PMID 33220140

Идентификаторы

NCT: NCT06443268 · 2023-00224

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗