Cerebrovascular Disease: Quality of Life (CODE: QoL)

NCT06443268 | Recruiting DMC

• 1 other identifier: 2023-00224
• Study Type: observational
• Target: 680
• Locations: 1 country
• Sites: 1

Brief 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. 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

Quality of Life; Stroke, Acute; Sexual Behavior; Stress; Cortisol Excess; Incontinence, Urinary; Caregiver Burden; Transient Ischemic Attack; Intracerebral Hemorrhage; Cerebrovascular Disorders

Keywords

Stroke, QoL, HRQoL, Patient-Caregiver dyads, Stress, Burden

Outcome Measures

Primary Outcomes (1)

• 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

  caregivers and patients at 0, 3 and 12 months after cerebrovascular event.

Secondary Outcomes (20)

• Stress

  caregivers and patients at 0, 3 and 12 months after cerebrovascular event.

• Positive Aspects of Caregiving:

  caregivers at 0, 3 and 12 months after cerebrovascular event.

• Zarit Burden Interview:

  caregivers at 0, 3 and 12 months after cerebrovascular event.

• Stroke Related Quality of Life

  patients at 0, 3 and 12 months after cerebrovascular event.

• Anxiety

  caregivers and patients at 0, 3 and 12 months after cerebrovascular event.

Study Arms (4)

Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

Patients with ischemic / hemorrhagic stroke, transient ischemic attack, intracerebral hemorrhage

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

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

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Caregivers of patients above

may include close relatives

Diagnostic Test: questionnaire, hair samples, blood samples, clinical exam

Interventions

questionnaire, hair samples, blood samples, clinical exam DIAGNOSTIC_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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Neurology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (25)

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 2749846 BACKGROUND

• 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: 3363593 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• 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: 17453683 BACKGROUND

• 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: 13638508 BACKGROUND

• 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: 11556941 BACKGROUND

• 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: 28627220 BACKGROUND

• 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: 24510195 BACKGROUND

• 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: 8560303 BACKGROUND

• 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: 15227649 BACKGROUND

• 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: 22150070 BACKGROUND

• 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: 19027446 BACKGROUND

• 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: 27548503 BACKGROUND

• 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: 15074432 BACKGROUND

• 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: 25955112 BACKGROUND

• 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.

  PMID: 28088111 BACKGROUND

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hair samples, routine blood samples

MeSH Terms

Conditions

Stroke; Sexual Behavior; ACTH Syndrome, Ectopic; Urinary Incontinence; Caregiver Burden; Ischemic Attack, Transient; Cerebral Hemorrhage; Cerebrovascular Disorders

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Brain Ischemia; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Susanne Wegener, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anton Schmick, MD

CONTACT

+41442551111; anton.schmick@usz.ch

Susanne Wegener, MD

CONTACT

+41442551111; susanne.wegener@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 4, 2024
• First Posted: June 5, 2024
• Study Start: May 27, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 5, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)