Spitex-SpiTal-Autonomie-Reha-Kraft

NCT03154684 | Terminated

• 1 other identifier: 2016-01820
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis; Frailty; Hip Fractures

Keywords

Autonomy; Rehabilitation; Falls; Quality of life; Senior

Outcome Measures

Primary Outcomes (1)

• Lower extremity function

  Lower extremity function will be measured by the Short Physical Performance Battery (SPPB)

  12 months

Secondary Outcomes (17)

• Gait speed

  12 months

• Gait speed

  12 months

• Grip strength

  12 months

• Repeated sit-to-stand

  12 months

• Rate of falls

  12 months

Other Outcomes (1)

• Interaction of family carer with hip-fracture patient and health professionals

  12 months

Study Arms (2)

STARK intervention

ACTIVE COMPARATOR

New care concept for hip fracture patients

Other: STARK intervention

Standard Care

OTHER

Swiss standard of care for hip fracture patients

Other: Standard of Care

Interventions

STARK intervention OTHER

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

STARK intervention

Standard of Care OTHER

Standard of Care involves inpatient rehabilitation or home-based or inpatient transitional nursing care

Standard Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University of Zurich: lead
• Spitex Zürich, Switzerland: collaborator
• City of Zurich, Switzerland: collaborator
• University Hospital, Zürich: collaborator
• University of Applied Sciences of Western Switzerland: collaborator
• Ebnet Stiftung, Switzerland: collaborator

Study Sites (1)

Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich

Zurich, Canton of Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Osteoporosis; Frailty; Hip Fractures

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Heike Bischoff-Ferrari, Prof.

  Zentrum Alter und Mobilität

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 16, 2017
• Study Start: May 5, 2017
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)