Smart Care for Older Persons Recovering From Hip-fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 158
- 试验地点
- 3
- 主要终点
- muscle endurance
研究概览
简要总结
The proposed study aims to examine the costs and effects of a Smart Care Model using smart clothing with alarm sensors that detect fall risks and monitor/give feedback on continuously recorded daily activity levels.
This mixed-method study will include a quantitative component (a randomized control trial) and a qualitative component. Data will be collected and analyzed using an embedded type of mixed method, i.e., a small qualitative component will be embedded in a larger quantitative study. Before the study, we will seek institutional review board approval. The quantitative component, a randomized experimental design, will examine the effectiveness of the Smart Care Model. The control group will receive only usual care, and the experimental group will receive Smart Care. Subjects will be recruited from the trauma wards of Chang Gung Memorial Hospital (CGMH) at Linkou and New Taipei Tucheng hospital. The sample will include 158 subjects, with 79 in each group. Patients and caregivers in both groups will be assessed 8 times: at admission, before discharge, 1, 3, 6, 12, 18, and 24 months following hospital discharge. Outcomes will include (a) patient outcomes (clinical outcomes, self-care ability, adherence, service utilization, health-related quality of life [HRQoL] and cost of care), and (b) family caregiver outcomes (preparedness, perceived balance between competing needs, depressive symptoms and HRQoL). Analyses will follow an intention-to-treat principle. The effects of the Smart Care Model on health outcomes will be analyzed by hierarchical linear models. The qualitative component will follow the collection of quantitative data. A subset of 10 patients and their family caregivers will be chosen from participants who receive Smart Care, and 10 who receive routine care for in-depth personal interviews consisting of open-ended questions. Interviews will be transcribed verbatim and analyzed as suggested by Miles and Huberman (1994). After both quantitative and qualitative data are collected, the quantitative and qualitative results will be integrated, compared, and contrasted to fully explore the study aims.
详细描述
Specific Aims and Hypothesis:
The proposed research aims to examine the effects of a Smart Care Model (SCM) on the health outcomes of older patients recovering from hip-fracture surgery (hip-fractured older patients) and on their caregivers' caregiving burden. The SCM entails real-time activity monitoring and feedback using smart clothing with sensors embedded in a computer network.
The proposed study has the following specific aims.
- To pretest, finalize and evaluate the protocol for the SCM.
- To evaluate the effectiveness of usual care and the SCM for hip-fractured elders in a randomized control trial. Effects of the two care models will be evaluated by comparing the trajectories of selected outcome variables: patients' clinical outcomes, self-care ability, subsequent falls, health-related quality of life (HRQoL), adherence, and service utilization as well as family caregivers' preparedness, perceived balance between competing needs, depressive symptoms, and HRQoL.
During the first year after hospital discharge, hip-fractured elderly patients who receive the SCM will 2-1. Have better clinical outcomes, self-care ability, adherence and HRQoL and fewer subsequent falls than those who receive usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and families will not be aware of their group enrollment and will be masked to the care model they receive. Research nurses who collect data will be independent of those who deliver the interventions.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years old
- •admitted to CGMH from its emergency department due to one-side hip fracture,
- •received hip arthroplasty or internal fixation
- •can perform full range of motion against gravity and against some or full resistance
- •pre-fracture Chinese Barthel Index (CBI) score > 70
- •living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).
排除标准
- •severe cognitive impairment that makes them unable to follow orders (Chinese Mini-Mental State Examination score <10)
- •terminally ill
- •without a primary family caregiver
- •living in an institution.
结局指标
主要结局
muscle endurance
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include muscle endurance
mortality
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include mortality.
ADL
时间窗: from 1 to 24 months following hospital discharge
Self-care abilities will include performance of ADLs.
EQ5D
时间窗: from 1to 24 months following hospital discharge
HRQoL of hip-fractured older persons will be measured by the Taiwan-version five-dimension, three-level EuroQol questionnaire (EQ-5D-3L) for cost-effective analysis (Chang et al., 2007).
flexibility
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include flexibility
Range of motion
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include ROM of affected limb
hospital re-admission rate
时间窗: from 1 to 24 months following hospital discharge
Information on service utilization will include hospital re-admission rate
complications
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include complications
IADL
时间窗: from 1 to 24 months following hospital discharge
Self-care abilities will include performance of IADL.
length of hospital stay
时间窗: from 1 to 24 months following hospital discharge
Information on service utilization will include length of hospital stay (LOS)
emergency department visits
时间窗: from 1 to 24 months following hospital discharge
Information on service utilization will include emergency department visits
Cost of care
时间窗: from 1 to 24 following hospital discharge
Cost-effectiveness of the SCM will be analyzed from the perspectives of the health care system and society. All health care costs will be derived from actual hospital information-system costs, the National Health Insurance claims database, patient self-reported out-of-pocket payments, and data from published and unpublished sources.
Health-related quality of life (HRQoL)
时间窗: from 1to 24 months following hospital discharge
HRQoL of hip-fractured older persons will be measured by the SF-36 Taiwan-version (Lu, Tseng, \& Tsai, 2003; Shyu, Chen, Liang, Lu et al., 2004; Tseng, Lu, \& Tsai, 2003).
muscle strength
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include muscle strength
pain intensity
时间窗: from 1 to 24 months following hospital discharge
These outcomes will include pain
Adherence
时间窗: from 1 to 24 months following hospital discharge
We will measure the adherence to continuous rehabilitation. Family caregivers will be asked to keep a diary to record frequencies and types of daily rehabilitation performed by older persons as in our prior studies.
次要结局
- Balance between competing needs(1, 3, 6, 12, 18, 24 months following hospital discharge)
- Caregiver depressive symptoms(1, 3, 6, 12, 18, 24 months following hospital discharge)
- Caregiver preparedness(1, 3, 6, 12, 18, 24 months following hospital discharge)
- Caregiver HRQoL(1, 3, 6, 12, 18, 24 months following hospital discharge)
研究者
Yea-Ing Lotus Shyu
Professor
Chang Gung Memorial Hospital