A Care Model for Elderly Hip-fractured Persons With Cognitive Impairment and Their Family Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Change from baseline Total Range of Motion to one year
研究概览
简要总结
This study aims to develop and examine an innovative family-centered intervention model for managing cognitive decline, improving postoperative recovery of hip-fractured patients with cognitive impairment, and enhancing family caregivers' competence in dementia care. This care model is theoretically underpinned by: (a) the Progressively Lowered Stress Threshold Model, a component of Lawton's ecological model of aging, and (b) the concept of partnership with family caregivers to strengthen their competence in providing care. Training are provided to family caregivers to enhance their competence in caring for hip-fractured patients with cognitive impairment. The effectiveness of the care model has been evaluated in a randomized controlled trial. The study was approved by the Institutional Review Board of Chang Gung Memorial Hospital. A protocol of the family-centered care model was developed, and the research nurses were trained to provide the interventions. A checklist, consisting of postoperative care, rehabilitation exercises, nutritional health teaching, environmental modification suggestions, delirium care, and care issues for elders with cognitive impairment, as well as management of behavioral problems, was also developed and are recorded by the research nurses. This report is based on data collected from 149 dyads of participants who were recruited by September 2018 and randomly assigned to either an experimental group (n=73) or a control group (n=76). No significant differences are found between experimental and control group in their demographic and clinical variables including age, gender, diagnosis, surgery type, the length of hospital stay, the cognitive functioning, marital status, and educational level, as well as the age and gender of family caregivers. The refusal rate this year is 73.6%. The main reasons for caregivers not participating are not needed and too busy or afraid of being interrupted. No significant differences are found in demographic variables (ie, age, gender, diagnosis, surgery method, and length of hospital stay) between those who participated and those who refused. Causes of the attrition includes that participants refused to participate any more (n=25), died (n=12), moved to another location (n=6), and loss of contact (n=3). Older persons who quit participating in the study are more younger (p=.021) and more are diagnosed with inter-/sub-trochanteric fracture (p=.015) as well as more are receiving internal fixation (p=.029). Outcome variables including patients' cognitive function, clinical measures, self-care ability, family caregivers' competence and preparedness, health service utilization, quality of life, and cost of care. In addition to the clinical effectiveness of the family-centered care model will be evaluated by hierarchical linear models at the end of this study.
详细描述
In this proposed clinical trial, the investigators intend to develop and examine an innovative family-centered intervention care model for managing cognitive decline, improving postoperative recovery of hip-fractured patients with cognitive impairment, and enhancing family caregiver's competence in dementia care. This study is innovative in two aspects: first, its focus on older persons with comorbid conditions of cognitive impairment and hip fracture, and second, the development of a family-centered care model for this population. Therefore, the goal of this proposed study is to examine the cost and effects of a family-centered care model that includes a family-centered interdisciplinary care component, and a training/support component for family caregivers of hip-fractured patients with cognitive impairment. The control group receives only usual care and the experimental group receives usual care and family-centered care.
The specific aims are:
- To develop a family-centered care model for hip-fractured elders with cognitive impairment, consisting of family-centered geriatric assessment, continuous rehabilitation, and supported discharge planning, and a family caregiver training/support component to manage symptoms and behavioral problems associated with cognitive decline and enhance postoperative recovery of hip-fractured patients with cognitive impairment and to increase caregiver's competence in dementia care. The protocol is pre-tested within the context of a randomized intervention study subject to existing constraints of the clinical (i.e., CGMH) and community settings.
- To evaluate the effectiveness of usual care and the family-centered care model for hip-fractured elders with cognitive impairment 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, cognitive function, behavioral problems, health-related quality of life (HRQoL), and service utilization, and family caregivers' preparedness, competence, and HRQoL. Predictors of recovery trajectories for the usual care and family-centered care models will also be compared.
- If the effectiveness of the family-center care is established, the costs associated with the usual care and family-centered care models will be analyzed. Cost items include: (1) costs for personnel time and home care visits, (2) costs of hospitalization, (3) costs of emergency or outpatient visits after hospital discharge due to a fall or re-fracture in the same location, and due to diagnosis/treatment for post-operative cognitive impairment, (4) patients' out-of-pocket costs for equipment such as walkers, crutches, nutritional supplements, or other necessities to improve their health conditions or to support walking, and (5) transportation expenses for patients and primary caregivers to visit hospitals or costs of time away from work.
Hypotheses
Based on results from previous studies on the effects of the interdisciplinary care model (Shyu et al., 2005, 2008) and of the family caregiver training program for patients with dementia (Huang et al., 2013; Kuo et al., 2013), following hypotheses are proposed. During the first year after hospital discharge, elderly hip-fractured patients with cognitive impairment who receive the family-centered care model will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
All participants will be informed that there two groups of the study. They will be randomized and allocated to one group and the research assistant explains the study to you does not know which group you will be, nor does the outcome assessor.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are:
- •age 60 years or older,
- •admitted to CGMH due to one-side hip fracture, and being diagnosed as needing surgery,
- •assessed as having cognitive impairment by the Chinese Mini-Mental State Examination (CMMSE) (CMMSE score < 21 with < 6 years education, or CMMSE < 25 with ≥ 6 years education; Yip et al., 1992),
- •having a primary family caregiver,
- •living in northern Taiwan (i.e., greater Taipei area, Keelung, Taoyuan, or Shin-Ju province).
- •Family caregivers:
- •age 20 years or older,
- •responsible for providing direct care to or supervising care received by the patient.
排除标准
- •Subjects are
- •cognitively intact by CMMSE,
- •without a primary family caregiver,
- •terminally ill,
- •severe cognitive impairment such that they are completely unable to follow orders (CMMSE < 10; Yip et al., 1992).
结局指标
主要结局
Change from baseline Total Range of Motion to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Total range of motion of hip is measured using the sum of hip flexion and hip extension in degree.
Change from baseline Muscle strength to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Using physical examination to measure muscle strength of lower limbs in pond.
Change from baseline Flexibility to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Using physical examination to measure flexibility in centimeter (cm).
Change from baseline Physical function to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed up to 12 months
Physical function is measured using the performance of Activities of Daily Livings (ADLs). The performance of ADLs is assessed by the Chinese Barthel Index (CBI). The reliability and validity of the measure has been established (Chen, Dai, Yang, Wang, \& Teng, 1995) and supported in our prior studies (Shyu et al., 2005, 2008).
Change from baseline Cognitive function to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at 1 month, 3 months, 6 months and up to 12 months
Cognitive function is measured using the MMSE Taiwan version. The 11-item MMSE Taiwan version assesses subjects' orientation, memory, common sense, ability to use language, ability to construct thoughts, as well as content of thought, form, and process (Folstein, Folstein, \& McHugh, 1975; Yip et al., 1992). Participants are categorized using MMSE at admission as cognitively impaired if \< 6 years of education and their MMSE score is \< 21, or if ≥ 6 years of education and their MMSE score is \< 25 (Yip et al., 1992). Acceptable reliability and validity were reported for the Taiwan version of MMSE.
Change from baseline Behavioral problems to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Behavioral problems of hip-fractured patients with cognitive impairment are measured using the Chinese version Cohen-Mansfield Agitation Inventory (CMAI), community form. The Chinese version CMAI has been shown to be valid and reliable for a Taiwanese sample (Huang et al., 2013; Huang, Shyu, Chen, Chen, \& Lin, 2003). Each item is scored according to the frequency of the problem, ranging from 1 (never happens) to 7 (several times per hour). Cronbach's alpha for the Chinese version CMAI in patients with dementia was 0.83 (Huang et al., 2013).
Change from baseline Caregiver competence to one year
时间窗: From date of randomization until the date of discharge came first and then progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Caregiver competence are measured using the 17-item Chinese version Caregiver Competence Scale (Huang \& Shyu, 2003) developed from the original scale (Kosberg \& Cairl, 1991). This scale measures caregiver knowledge and skills for managing behavioral problems of patients with dementia. Items include whether the caregiver can search for related information in books and from health professionals, discuss patient behaviors with family members, provide an appropriate environment, assist and monitor medications, and handle patient's physical, emotional, and social needs. Items are scored from 1 (never) to 5 (always). Total scores range from 17 to 85; higher scores represent better competence. This scale had a content validity index of 0.89 and Cronbach's alphas of 0.75 - 0.90 in caregivers of patients with dementia (Huang \& Shyu, 2003; Huang et al., 2013).
Change from baseline Delirium to one year
时间窗: From date of randomization until the date of discharge came first and then the progressions assessed at the 1 month, 3 months, 6 months and up to 12 months
Patients are screened for delirium at the hospital following hip-fracture surgery using the Delirium Rating Scale, revision 98 (DRS-R-98), which was modified from the Delirium Rating scale (DRS). The DRS has 16 items, with 13 items measuring delirium severity and 3 diagnostic items. Scores for each severity item range from 0-3 and for each diagnostic item range from 0-2 or 0-3. Total scores from 0-7 are regarded as normal, 8-13 indicates pre-delirium, and \> 14 indicates delirium. The DRS was found to effectively differentiate delirium from cognitive disturbance caused by dementia, depression, or schizophrenic disorder (Franco, Trzepacz, MejÍa, \& Ochoa, 2009). The Taiwan version of the DRS-R-98 was found to have good validity and reliability (Huang et al., 2009)
次要结局
- Change from one-month Service utilization to one year(up to one year)
- Change from baseline Health-related quality of life (HRQoL) to one year(up to 12 months)
- Change from baseline Cost of care to one year(up to 12 months)
研究者
Yea-Ing Lotus Shyu
Principle Investigator
Chang Gung Memorial Hospital