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Recruiting NCT06443268

Cerebrovascular Disease: Quality of Life (CODE: QoL)

— Observational Quality of Life Stroke, Acute Sexual Behavior Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: questionnaire, hair samples, blood samples, clinical exam.
Who it may be relevant to
Registry conditions: Quality of Life, Stroke, Acute, Sexual Behavior, Stress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Department of Neurology, University Hospital Zurich — Zurich

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. 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

Identifiers

NCT: NCT06443268 · 2023-00224

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗