Cerebrovascular Disease: Quality of Life (CODE: QoL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 680
- 试验地点
- 1
- 主要终点
- Quality of Life as assessed via Short Form - 36 (SF-36)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of Life as assessed via Short Form - 36 (SF-36)
时间窗: 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
次要结局
- Stress(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- Sexual Quality of Life(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- Incontinence(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- Quality of Life (short)(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.)
- 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.)
- Depression(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- neurological functioning of the patients (mRS)(patients at 0, 3 and 12 months after cerebrovascular event.)
- Distress(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- cortisol / cortisone in hair (pg/mg)(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- fasting glucose (mmol/l)(patients at 0, 3 and 12 months after cerebrovascular event.)
- Blood pressure (systolic & diastolic in mmHg)(caregivers and patients at 0, 3 and 12 months after cerebrovascular event.)
- Zarit Burden Interview:(caregivers at 0, 3 and 12 months after cerebrovascular event.)
- neurological functioning of the patients (NIHSS)(patients at 0, 3 and 12 months after cerebrovascular event.)
- neurological functioning of the patients (Barthel Index)(patients at 0, 3 and 12 months after cerebrovascular event.)
- HbA1c (in %)(patients at 0, 3 and 12 months after cerebrovascular event.)
- Lipid profiles (LDL, HDL, triglycerides in mmol/l)(patients at 0, 3 and 12 months after cerebrovascular event.)
- TSH (mU/l)(patients at 0, 3 and 12 months after cerebrovascular event.)
研究者
Susanne Wegener
Prof. Dr. med.
University of Zurich