Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03154684 |
| Other study ID # |
2016-01820 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 5, 2017 |
| Est. completion date |
August 15, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
University of Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
This is a randomized controlled pilot trial with two parallel groups including a control
group receiving standard of care (inpatient rehabilitation or home-based or inpatient
transitional nursing care) and an intervention group receiving the STARK comprehensive
autonomy health care package. The STARK comprehensive autonomy health care package consists
on one hand of the STARK-Spitex who will support the participants during the first three
months at home and on the other hand of a secondary prevention program including home
exercise (3x/week), protein enriched food preparation (20 g whey protein/day), motivation and
recommendation for vitamin D supplementation(2000 IE/day), calcium intake and physical
activity. The intervention starts already during acute care and involves a multidisciplinary
team of geriatricians, nurses and Spitex who assess the care and utilities needs of the
patient. Each study participant will undergo 5 clinical visits (at baseline, after 6 weeks, 3
months, 6 months, and 12 months). Between clinical visits, participants will be contacted by
phone every month.
The STARK comprehensive autonomy health care package can contribute to a faster and
sustainable recovery of autonomy after a hip fracture in seniors and might help to lower
direct and indirect health care costs by reducing the number of re-hospitalization due to
fall-associated injuries.
