SupporTive Care At Home Research : Single-center, Single-arm, Investigator-initiated Exploratory Clinical Trial for Patients with Neurologic Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Unplanned hospitalization
研究概览
简要总结
To test the effects of home-based care on healthcare utilization within one Year (Hospitalization Status, Number of Hospitalizations, Unplanned Hospitalization Status, Number of Unplanned Hospitalizations, Length of Hospital Stay, Number of Emergency Room Visits, Number of Outpatient Visits) among progressive neurologic disease patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.
详细描述
This study is a Single-center, single-arm, investigator-initiated exploratory clinical trial to test the effects of home-based care on Healthcare Utilization within One Year (Hospitalization Status, Number of Hospitalizations, Unplanned Hospitalization Status, Number of Unplanned Hospitalizations, Length of Hospital Stay, Number of Emergency Room Visits, Number of Outpatient Visits)among neurologic disease Patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. Study participants are recruiting from single institutions, aiming for 30 progressive neurologic disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both the patient and their family caregiver must meet the criteria to be considered for this research.
- •Diagnosis of Progressive Neurological Disorders (Motor Neuron Disease, Parkinson's Disease) with ICD-10 codes (G12.2, G20, G11.9, G21, G22, G23, G30.8, G31.8, F02.3, etc.), additional diseases can be included depending on the patient's condition.
- •Individuals with a modified Rankin Score (mRS) of 3-5 A person who wishes to stay at home A person whose family caregiver resides at home A person who wishes to participate in the research Family Caregiver
- •A family* member of the patient
- •* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree.
- •A person who meets one of the following conditions:
- •Lives with the patient (patient's household member) Does not live with the patient, but visits the patient's home more than three times a week A person who wants the patient to stay at home A person who can communicate easily with medical staff A person who wishes to participate in the research
排除标准
- •If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.
- •A person who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)*
- •* This condition is not applicable for the control group.
- •A person who has used hospital- or home-type hospice and palliative care services A person who is under the age of 19 Family Caregiver
- •A person who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health A person under the age of 19
结局指标
主要结局
Unplanned hospitalization
时间窗: within One Year
admission to the enrolled hospital to treat unexpected symptoms or medical conditions (not including planned admission for chemotherapy or admission for planned surgery or intervention) admission to a hospital other than the enrolled hospital admission to a nursing hospital for a duration of less than 4 weeks.
次要结局
- Patient medical utilization(within 12 months following enrollment)
- Hospitalization(within 12 months following enrollment)
- ER visits(within 12 months following enrollment)
- Healthcare use(within 12 months following enrollment)
- Patient end-of-life care: ICU admission(within 1 month before death)
- Patient end-of-life care: ventilator treatment(within 1 month before death)
- Patient end-of-life care: an advance directive(within 1 month before death)
- symptom management(within 12 months following enrollment)
- Quality of life of patient - EQ-5D(within 12 months following enrollment)
- Satisfaction with services (patient)(within 12 months following enrollment)
- Quality of life of family caregiver(within 12 months following enrollment)
- Care burden of family caregiver(within 12 months following enrollment)
- Depressive symptom of family caregiver(within 12 months following enrollment)
- Caring competency of family caregiver(within 12 months following enrollment)
- Satisfaction with services (family caregiver)(within 12 months following enrollment)
- Expenses(within 12 months following enrollment)
研究者
BeLong Cho
professor
Seoul National University Hospital