Spitex-SpiTal-Autonomie-Reha-Kraft

• Register: ClinicalTrials.gov
• Last refreshed on: 7 September 2021
• Main ID: NCT03154684
• Date of registration: 04/05/2017
• Prospective Registration: Yes
• Primary sponsor: University of Zurich
• Public title: Spitex-SpiTal-Autonomie-Reha-Kraft STARK
• Scientific title: Efficacy of the STARK Comprehensive Autonomy Health Care Package in Functional Recovery After a Hip Fracture: A Randomized Controlled Trial
• Date of first enrolment: May 5, 2017
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03154684
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Heike Bischoff-Ferrari, Prof.
• Affiliation: Zentrum Alter und Mobilität

Key inclusion & exclusion criteria

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).



Age minimum: 70 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoporosis

Hip Fractures

Frailty

Intervention(s)

Other: STARK intervention

Other: Standard of Care

Primary Outcome(s)

Lower extremity function [Time Frame: 12 months]

Secondary Outcome(s)

Number of re-hospitalizations [Time Frame: 12 months]

Quality of life [Time Frame: 12 months]

Rate of falls [Time Frame: 12 months]

Health care utilization [Time Frame: 12 months]

Cognitive function [Time Frame: 12 months]

Bone mineral density [Time Frame: 12 months]

Number of nursing home admissions [Time Frame: 12 months]

Adherence to preventive strategies [Time Frame: 3 months]

Repeated sit-to-stand [Time Frame: 12 months]

Gait speed [Time Frame: 12 months]

Activities of daily living [Time Frame: 12 months]

Adherence to preventive strategies [Time Frame: 12 months]

Appendicular muscle mass [Time Frame: 12 months]

Grip strength [Time Frame: 12 months]

Secondary ID(s)

2016-01820

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Applied Sciences of Western Switzerland

City of Zurich, Switzerland

Ebnet Stiftung, Switzerland

Spitex Zürich, Switzerland

University Hospital, Zürich