Spitex-SpiTal-Autonomie-Reha-Kraft — STARK  

Osteoporosis Clinical Trial

Official title: Efficacy of the STARK Comprehensive Autonomy Health Care Package in Functional Recovery After a Hip Fracture: A Randomized Controlled Trial

Status Terminated

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Frailty
• Hip Fractures
• Osteoporosis

• NCT number: NCT03154684
• Study type: Interventional
• Source: University of Zurich
• Status: Terminated
• Phase: N/A
• Start date: May 5, 2017
• Completion date: August 15, 2021