Efficacy of the STARK Comprehensive Autonomy Health Care Package in Functional Recovery After a Hip Fracture: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Lower extremity function
研究概览
简要总结
The primary purpose of this study is to test if the STARK comprehensive autonomy health care package improves lower extremity function over time at 6 weeks, 3, 6 and 12 months after hip or pelvis fracture compared to the standard of care.
详细描述
Hip fractures are the most frequent and most severe fractures among seniors age 75 and older and they have severe consequences: After a hip fracture, 50% of older persons have permanent functional disabilities, 15-30% require long-term nursing home care, and 10-20% die within one year. Besides the personal burden, hip fractures account for substantial increasing health care expenses. Given the high prevalence, severity and cost of hip fractures, novel care concepts such as STARK are urgently needed to support functionality and autonomy of hip fracture patients - especially in for the first year after the fracture
The STARK Intervention is a new care concept for hip fracture patients, which was developed based on prior evidence from clinical trials performed at the Centre on Aging and Mobility at the University of Zurich and important interdisciplinary clinical expertise collected at the Geriatric Trauma Centre at the University Hospital Zurich, the Spitex Zürich, the Dept. of Geriatrics at the University Hospital Zurich, and the Federal Department of Health at the City of Zurich (Gesundheits- und Umweltsdepartement).
The aim of the STARK intervention is to enable hip fracture patient to return to their home directly after discharge from acute care by providing a high-quality care concept provided by an interdisciplinary team bridging acute Geriatric Care at the University Hospital and Spitex services (ambulant nursing service at home).
With this pilot study, the investigators want to test if the STARK comprehensive autonomy care package improves lower extremity function in the first year after a hip fracture compared to standard of care. Most important secondary outcomes are rate of falls, health care utilization, re-hospitalization and nursing home admission, as well as quality of life, cognitive function, bone mineral density and muscle mass in senior hip fracture patients.
This study will include 20 community-dwelling men and women aged 70+ who are hospitalized at the University Hospital Zurich or City Hospital Waid due to an acute hip or pelvis fracture and who are not capable to return home without help.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling prior to the hip fracture event
- •Living alone or with a partner/family member
- •Living in the city of Zurich
- •Acute hip or pelvis fracture after minimal trauma (resulting from a fall occurring from a standard height and without the involvement of others or a vehicle)
- •Living at home without or with minimal (i.e. no more than 1x/day) support from the Spitex (ambulant nursing service) before the hip fracture
- •Participant is mentally competent (judicious) based on the treating physicians' opinion at the screening visit.
- •Inpatient rehabilitation or inpatient transitional care at a nursing home or ambulatory standard of care
- •The participant understands the study procedures and voluntarily agree to participate in the study and comply with all its procedures by giving written informed consent
排除标准
- •Patients who are expected to return home without help (i.e. no more care than Spitex 1x/day or physiotherapy 2x/week needed) directly after acute care are excluded.
- •Conservative treatment of acute hip fracture or surgical treatment that does not allow full weight bearing after surgery
- •Currently under cancer treatment or has active cancer (except for non-melanoma skin cancer)
- •Major visual or hearing impairment (visual and/or hearing aids are allowed) or other serious illness that would preclude participation
- •24-hour nursing care need as this cannot be offered within the STARK package
- •Mobility impairment that precludes return to own apartment
- •Planned nursing home admission after acute hospital stay
- •Current participation in another clinical trial, or plans of such participation in the next 12 months (corresponding to the study duration)
- •Inability to read and/or speak German to an extent necessary to understand instructions and participate in the study
- •Unwilling to forego any additional vitamin D supplementation (bolus or regular intake).
结局指标
主要结局
Lower extremity function
时间窗: 12 months
Lower extremity function will be measured by the Short Physical Performance Battery (SPPB)
次要结局
- Repeated sit-to-stand(12 months)
- Grip strength(12 months)
- Gait speed(12 months)
- Quality of life(12 months)
- Number of nursing home admissions(12 months)
- Number of re-hospitalizations(12 months)
- Rate of falls(12 months)
- Health care utilization(12 months)
- Adherence to preventive strategies(12 months)
- Appendicular muscle mass(12 months)
- Bone mineral density(12 months)
- Activities of daily living(12 months)
- Cognitive function(12 months)