Cerebrovascular Disease: Quality of Life (CODE: QoL)

Quality of Life Clinical Trial

— CODE:QoL  

Official title:

Cerebrovascular Disease: Quality of Life (CODE: QoL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443268
• Other study ID #: 2023-00224
• Status: Recruiting
• Start date: May 27, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Anton Schmick, MD
• Phone: +41442551111
• Email: anton.schmick[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 680
• Est. completion date: June 30, 2028
• Est. primary completion date: April 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Cerebral Hemorrhage
• Cerebrovascular Disorders
• Enuresis
• Hemorrhage
• Incontinence, Urinary
• Intracerebral Hemorrhage
• Ischemic Attack, Transient
• Quality of Life
• Sexual Behavior
• Stress
• Stroke
• Stroke, Acute
• Transient Ischemic Attack
• Urinary Incontinence

Intervention

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 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.

Locations

Country	Name	City	State
Switzerland	Department of Neurology, University Hospital Zurich	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (25)

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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. — View Citation

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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. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stress	as assessed using Perceived Stress Scale - 10 (PSS-10); Scoring is based on 2 subscales: Subscale 1: Perceived self-efficacy (PSE), range: (4-20); Subscale 2: Perceived helplessness (PH), range: (6-30); Total score PSS-10 is evaluated by adding both sub scale scores.; Values span from 10 to 50, higher values indicate higher levels of stress	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Positive Aspects of Caregiving:	Measure of caregiver burden; Questionnaire: 11 items / Likert scales (1-5); Values span from 11 to 55, higher values indicate positive aspects of caregiving	caregivers at 0, 3 and 12 months after cerebrovascular event.
Secondary	Zarit Burden Interview:	Measure of caregiver burden; 22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burden	caregivers at 0, 3 and 12 months after cerebrovascular event.
Secondary	Stroke Related Quality of Life	will be assessed using Stroke Impact Scale 3.0 (SIS-3.0); SIS-3.0 includes 60 items and assesses 9 domains using Likert scales: Strength - 4 items; Hand function - 5 items; Activities of daily living - 10 items; Mobility - 9 items; Communication - 7 items; Emotion - 9 items; Memory and thinking - 7 items; Participation/Role function - 8 items; Perceived recovery since stroke onset - single-item VAS (visual analog scale); Domains are scored seperately; Values span from 0 to 100, higher values indicate fewer limitations	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Anxiety	will be assessed using General Anxiety Disorder- (GAD-7); 7 items / Likert scales (0-3) Values span from 0 to 21, higher values indicate higher level of anxiety and functional impairment	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Depression	will be assessed using Patient Health Questionnaire - 9 (PHQ-9); 9 items, evaluated by likert scale (0-3) Values span from 0 to 27, higher values indicate higher probability of depression and decreased functional status	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Sexual Quality of Life	will be assessed using Sexual Behavior Questionnaire German (SBQ-G); Equal base questions (1-6) and gender specific questions m(7-11), f(7-10); Single item evaluation with two answer categories; (0-1) dysfunctional (2-3) functional; Evaluation of MGISD (Mean Global Index of sexual Dysfunction): Arithmetic mean of 1,4,5,6,8f/11m	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Incontinence	will be assessed using International Consultation on Incontinence Questionnaire (ICIQ); 3 Questions regarding urinary incontinence; Frequency?; Severity?; Impact on quality of life?; Score is sum of answer values (1 + 2 + 3); Range: 0-21; Scoring Categories; slight (1-5); moderate (6-12); severe (13-18); very severe (19-21)	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	neurological functioning of the patients (NIHSS)	will be assessed using National Institutes of Health Stroke Scale (NIHSS); NIHSS; 13 assessed functional domains; Range 0-42, higher score indicates severe impairment	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	neurological functioning of the patients (mRS)	will be assessed using modified Rankin Scale (mRS); mRS; • Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	neurological functioning of the patients (Barthel Index)	will be assessed using Barthel Index; Barthel Index; Physical impairment in daily life / self-care; score ranges from 0-100; higher score indicates fewer limitations	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Distress	will be assessed using Distress Thermometer; Assessment with Visual Analog Scale (0-10), higher scale indicates more distress.; Selection of aspects in life causing distress	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Quality of Life (short)	will be assessed using EuroQol-5 (EQ5-DL); Evaluation of 5 different aspects of health with likert scale (1-5); MOBILITY; SELF-CARE; USUAL ACTIVITIES; PAIN / DISCOMFORT; ANXIETY / DEPRESSION; Each domain is scored individually, higher values indicate higher impairment of quality of life	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Quality of Life (short)	will be assessed using EuroQol-5 (EQ5-DL); Visual analog scale: EQ VAS 0-100, higher score indicates better perceived current health	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	cortisol / cortisone in hair (pg/mg)	Stress biomarkers	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	fasting glucose (mmol/l)	Stress biomarkers	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	HbA1c (in %)	Stress biomarkers	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Lipid profiles (LDL, HDL, triglycerides in mmol/l)	Stress biomarkers	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	TSH (mU/l)	Stress biomarkers	patients at 0, 3 and 12 months after cerebrovascular event.
Secondary	Blood pressure (systolic & diastolic in mmHg)	Stress biomarkers	caregivers and patients at 0, 3 and 12 months after cerebrovascular event.