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NCT Number: NCT06443268

Cerebrovascular Disease: Quality of Life (CODE: QoL)

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.

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Key information

Conditions

Quality of Life ACTH Syndrome, Ectopic Behavior Behavioral Symptoms Brain Diseases Brain Ischemia Cardiovascular Diseases Caregiver Burden Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Cortisol Excess Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Incontinence, Urinary Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Attack, Transient Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Nervous System Diseases Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms Stress Stress, Psychological Stroke Stroke, Acute Transient Ischemic Attack Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location status: Recruiting

Location contact

Anton Schmick, MD

CONTACT

[email protected]

Schmick Anton, MD

SUB_INVESTIGATOR

Susanne Wegener, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. Stress

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

    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

  2. Positive Aspects of Caregiving:

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

    Measure of caregiver burden

    Questionnaire: 11 items / Likert scales (1-5)

    Values span from 11 to 55, higher values indicate positive aspects of caregiving

  3. Zarit Burden Interview:

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

    Measure of caregiver burden

    22 items / Likert scales (0-4) Values span from 0 to 88, higher values indicate higher caregiver burden

  4. Stroke Related Quality of Life

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

    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

  5. Anxiety

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

    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

  6. Depression

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

    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

  7. Sexual Quality of Life

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

    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

  8. Incontinence

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

    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)

  9. neurological functioning of the patients (NIHSS)

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

    will be assessed using National Institutes of Health Stroke Scale (NIHSS)

    NIHSS

    • 13 assessed functional domains
    • Range 0-42, higher score indicates severe impairment

  10. neurological functioning of the patients (mRS)

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

    will be assessed using modified Rankin Scale (mRS)

    mRS

    • Range: (0-6) 0 = no symptoms, 6 = death, higher score indicates severe impairment

  11. neurological functioning of the patients (Barthel Index)

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

    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

  12. Distress

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

    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

  13. Quality of Life (short)

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

    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

  14. Quality of Life (short)

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

    will be assessed using EuroQol-5 (EQ5-DL)

    Visual analog scale:

    EQ VAS 0-100, higher score indicates better perceived current health

  15. cortisol / cortisone in hair (pg/mg)

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

    Stress biomarkers

  16. fasting glucose (mmol/l)

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

    Stress biomarkers

  17. HbA1c (in %)

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

    Stress biomarkers

  18. Lipid profiles (LDL, HDL, triglycerides in mmol/l)

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

    Stress biomarkers

  19. TSH (mU/l)

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

    Stress biomarkers

  20. Blood pressure (systolic & diastolic in mmHg)

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

    Stress biomarkers

Study contacts

Contact information is provided by the study sponsor or research team.

Anton Schmick, MD

CONTACT

[email protected]

+41442551111

Susanne Wegener, MD

CONTACT

[email protected]

+41442551111

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Acronym: CODE:QoL

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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