Home-based Longitudinal Investigation of the Multidisciplinary Team Integrated Care (HOLISTIC)
2020年1月29日 更新者：Chao A. Hsiung、National Health Research Institutes, Taiwan
Developing Innovative Models for Health & Long-term Care Facilities and Technology Services: Prospective Cohort Study for Home Health Care
Some research found the effectiveness of implementation of home health care on patients' physical function, quality of life (QoL) and decreased the risk of hospitalization and medical costs.
However, little was known about the longitudinal change of comprehensive assessments of physical and mental health, QoL, well-being, and medical resource utilization of patients receiving home health care and their caregivers.
Furthermore, the evaluation of advance care planning, palliative care need, and the quality of dying and death were also insufficient among the aforementioned population.
Therefore, this cohort study aims to investigate the longitudinal change of health-related outcomes and utilization of resource utilization, and explore their trajectories in two years for patients who receive home health care and their caregivers in Taiwan.
研究概览
详细说明
This is a prospective longitudinal cohort study in Taiwan. Data will be collected by trained interviewers at the baseline (T0), 3-month follow-up (T1), 6-month follow-up (T2), 12-month follow-up (T3), 18-month follow-up (T4), and 24-month follow-up (T5). Via home visits, interviewer-administered questionnaires (informed consent, contact/follow-up information, background information, health condition, physical functioning, cognitive function, etc.) will be used. It estimates that the home visit will take up to 2 hours.
The investigators will recruit at least 1200 eligible patients and caregivers (600 dyads) from at least 15 institutions (e.g., home clinics and hospitals) which provide home health care. Trained research assistants will touch based with eligible participants recommended by institution staff and invite them to take part in the study. To ensure the study are achieving the target sample the investigators will examine the distribution of living area and number of participants in each type of home health care unit during recruiting. Moreover, the investigators have estimated an attrition rate of 20% over the study. Higher drop-off rates in certain sub-groups may be problematic, so the investigators will monitor participants' attrition.
In addition, the cohort the investigators enrolled will be linked to their data in Taiwan's National Health Insurance Research Database to analyze the medical resource utilization of participants in our study. The results will show the health status and resource utilization as well as quality of home health care in Taiwan for clinical practices, research and future policy making.
研究类型
观察性的
注册 (预期的)
1200
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Miaoli County
-
Zhunan、Miaoli County、台湾、35053
- Chao A. Hsiung
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
patients with home health care and their caregivers
描述
Inclusion Criteria:
- Aged 20 years or older
- Receiving home health care services at least two months
- Either the patient or caregiver can express clearly
Exclusion Criteria:
- Reject to sign the informed consent
- Both the patient and caregiver cannot complete the interview
- Both the patient and caregiver cannot communicate with an interviewer in a familiar language
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
patient
patients who receive home health care
|
|
caregiver
caregivers who take care of patients with home health care
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from ability to perform activities of daily living (ADL) at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
The Barthel Index will be adapted to assess ADL.
The total score ranges from 0 to 100, with 100 indicating full independence in doing daily activities.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from frailty at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the 9-point Clinical Frailty Scale (CFS).
The total score ranges from 1 to 9, with 7 or higher indicating severe frailty, even being terminally ill.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from cognitive function/memory at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the Brain Health Test (Chinese version) via testing the orientation to time, immediate and delayed recall of five items, categorical verbal fluency test.
The total score ranges from 0 to 16, with higher scores indicating worse cognitive impairment.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from percentage of participants with Dementia at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
The Functional Assessment Staging Test (FAST) will be adapted to assess an individual's stage of Alzheimer's disease.
It includes seven stages from normal aging to sever Dementia.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from mean score of depression at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the 5-item Geriatric Depression Scale (GDS).
The total score ranges from 0 to 5, with higher scores indicating more depression.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from neuropsychiatric status at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the Neuropsychiatric Inventory.
The 10 sub-domains of behavioral functioning are examined, including delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity syndrome.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from quality of life (QOL) at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
We will adapt the Quality of Life in Alzheimer's Disease (QOL-AD) scale for patients with cognitive impairment, and Quality of Life Survey for Home Care (QOL-HC) scale for those without cognitive impairment.
The total score of QOL-AD ranges from 13 to 52, with higher values indicating a higher QoL.
The total score of QOL-HC ranges from 0 to 8, with higher values indicating a higher QoL.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from mental wellbeing at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the World Health Organization- Five Well-Being Index (WHO-5).
The raw score ranges from 0 to 25, 0 representing worst possible and 25 representing best possible quality of life.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Shared decision making (SDM)
大体时间：Two years
|
It will be measured by the Decision-making Participation Self-Efficacy Scale (DEPS).
The total score ranges from 5 to 25, with higher scores indicating higher self-efficacy.
|
Two years
|
|
Advance Care Planning (ACP)
大体时间：Two years
|
It will be measured by the 4-question version of UCSF-ACP with the Process Measures (knowledge, contemplation, self-efficacy, and readiness, 5-point Likert scales) and Action Measures (yes/no whether an ACP behavior is completed).
|
Two years
|
|
Change from Nutrition status at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will include the Mini Nutritional Assessment (MNA).
The total score of MNA ranges from 0-14, with more than 11 indicating normal nutrition status.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from risk for pressure injury at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the sale of Braden Scale for Predicting Pressure Sore Risk.
The scale is composed of six subscales that reflect sensory perception, skin moisture, activity, mobility, friction and shear, and nutritional status.
The total score ranges from 6 to 23, with higher scores indicating lower risk for forming pressure sores.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Needs assessment for supportive & palliative care
大体时间：Two years
|
It will be measured by the Supportive & Palliative Care Indicators Tool (SPICT).
Following the guideline, the Chinese version will be developed before the cohort study starts.
|
Two years
|
|
Change from medical resource utilization at two years
大体时间：Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
|
Assessments include medical costs and out-of-pocket costs regarding utilization of medical resource and home health care.
The used scales are developed by our research team.
|
Baseline, 3-month follow-up, 12-month follow-up, 24-month follow-up
|
|
Change from caregiving burden at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by the revised version of Zarit Burden interview containing 22 items, with higher scores indicating greater burden.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
|
Change from number of used chronic disease drug at two years
大体时间：Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
It will be measured by two items which are developed by our research team.
Based on patients' prescriptions, they will be required to answer the number of chronic disease drug they used and these drugs' information, including the names, administrations and dosages.
|
Baseline, 3-month follow-up, 6-month follow-up, 12-month follow-up, 18-month follow-up, 24-month follow-up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Chao A. Hsiung, PhD、National Health Research Institutes, Taiwan
- 首席研究员：Sang-Ju Yu, MD、Taiwan Society of Home Health Care and Home Clinic Dulan
- 首席研究员：Ping-Jen Chen, MD、Kaohsiung Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年11月20日
初级完成 (实际的)
2019年11月20日
研究完成 (预期的)
2022年12月31日
研究注册日期
首次提交
2020年1月15日
首先提交符合 QC 标准的
2020年1月29日
首次发布 (实际的)
2020年1月31日
研究记录更新
最后更新发布 (实际的)
2020年1月31日
上次提交的符合 QC 标准的更新
2020年1月29日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.