Spitex-SpiTal-Autonomie-Reha-Kraft

Osteoporosis Clinical Trial

— STARK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03154684
• Other study ID #: 2016-01820
• Status: Terminated
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling prior to the hip fracture event

• Living alone or with a partner/family member

• Living in the city of Zurich

• age 70+

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Frailty
• Hip Fractures
• Osteoporosis

Intervention

Other:
• STARK intervention
The STARK Intervention is a new care concept for hip fracture patients that enable hip fracture patient to return to their home directly after discharge from acute care. The STARK comprehensive autonomy health care package includes following services; Multidisciplinary collaboration of geriatricians, nurses and Spitex (ambulant nursing service at home) starting already during acute care Inspection of the environment at the patient's home Care and autonomy support Social life support Secondary prevention strategies: Home exercise program (3x/weeks) Protein enriched food preparation (20g whey protein/day) Support to take vitamin D supplementation (2000 IU/day) Recommendation and support to eat calcium rich foods Motivation to be physically active
• Standard of Care
Standard of Care involves inpatient rehabilitation or home-based or inpatient transitional nursing care

Locations

Country	Name	City	State
Switzerland	Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich	Zürich	ZH

Sponsors (6)

Lead Sponsor	Collaborator
University of Zurich	City of Zurich, Switzerland, Ebnet Stiftung, Switzerland, Spitex Zürich, Switzerland, University Hospital, Zürich, University of Applied Sciences of Western Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Interaction of family carer with hip-fracture patient and health professionals	The interaction will be assessed by semi-structured interviews with a family carer.	12 months
Primary	Lower extremity function	Lower extremity function will be measured by the Short Physical Performance Battery (SPPB)	12 months
Secondary	Gait speed	Gait speed will be obtained from the SPPB.	12 months
Secondary	Gait speed	Gait speed will be assessed by a 400 m walk test.	12 months
Secondary	Grip strength	Hand grip strength will be measured using a Martin Vigorimeter.	12 months
Secondary	Repeated sit-to-stand	Repeated chair stand test will be obtained from the SPPB.	12 months
Secondary	Rate of falls	Rate of falls will be assessed by a monthly phone call.	12 months
Secondary	Health care utilization	Health care utilization will be assessed using the health care utilization questionnaire.	12 months
Secondary	Number of re-hospitalizations	All hospitalizations will be documented as part of the safety documentation(SAE).	12 months
Secondary	Number of nursing home admissions	All nursing home admissions will be documented.	12 months
Secondary	Adherence to preventive strategies	Adherence will be documented by the Spitex staff.	3 months
Secondary	Adherence to preventive strategies	Adherence will be documented by an adherence questionnaire.	12 months
Secondary	Quality of life	Quality of life will be assessed by the RAND SF-36 questionnaire.	12 months
Secondary	Quality of life	Quality of life will be assessed by the EuroQol (EQ-5D-3L) questionnaire.	12 months
Secondary	Cognitive function	Cognitive function will be assessed by the MoCA.	12 months
Secondary	Cognitive function	Cognitive function will be assessed by the MMSE.	12 months
Secondary	Appendicular muscle mass	Appendicular muscle mass will be assessed by dual energy X-ray absorptiometry.	12 months
Secondary	Bone mineral density	Bone mineral density will be assessed by dual energy X-ray absorptiometry.	12 months
Secondary	Activities of daily living	Activities of daily living will be assessed by questionnaire (PROMIS-HAQ)	12 months