Spitex-SpiTal-Autonomie-Reha-Kraft (STARK)

August 26, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8037
        • Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: STARK intervention
New care concept for hip fracture patients
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
Other: Standard Care
Swiss standard of care for hip fracture patients
Other: Standard of Care
Standard of Care involves inpatient rehabilitation or home-based or inpatient transitional nursing care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lower extremity function
Time Frame: 12 months
Lower extremity function will be measured by the Short Physical Performance Battery (SPPB)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: 12 months
Gait speed will be obtained from the SPPB.
12 months
Gait speed
Time Frame: 12 months
Gait speed will be assessed by a 400 m walk test.
12 months
Grip strength
Time Frame: 12 months
Hand grip strength will be measured using a Martin Vigorimeter.
12 months
Repeated sit-to-stand
Time Frame: 12 months
Repeated chair stand test will be obtained from the SPPB.
12 months
Rate of falls
Time Frame: 12 months
Rate of falls will be assessed by a monthly phone call.
12 months
Health care utilization
Time Frame: 12 months
Health care utilization will be assessed using the health care utilization questionnaire.
12 months
Number of re-hospitalizations
Time Frame: 12 months
All hospitalizations will be documented as part of the safety documentation(SAE).
12 months
Number of nursing home admissions
Time Frame: 12 months
All nursing home admissions will be documented.
12 months
Adherence to preventive strategies
Time Frame: 3 months
Adherence will be documented by the Spitex staff.
3 months
Adherence to preventive strategies
Time Frame: 12 months
Adherence will be documented by an adherence questionnaire.
12 months
Quality of life
Time Frame: 12 months
Quality of life will be assessed by the RAND SF-36 questionnaire.
12 months
Quality of life
Time Frame: 12 months
Quality of life will be assessed by the EuroQol (EQ-5D-3L) questionnaire.
12 months
Cognitive function
Time Frame: 12 months
Cognitive function will be assessed by the MoCA.
12 months
Cognitive function
Time Frame: 12 months
Cognitive function will be assessed by the MMSE.
12 months
Appendicular muscle mass
Time Frame: 12 months
Appendicular muscle mass will be assessed by dual energy X-ray absorptiometry.
12 months
Bone mineral density
Time Frame: 12 months
Bone mineral density will be assessed by dual energy X-ray absorptiometry.
12 months
Activities of daily living
Time Frame: 12 months
Activities of daily living will be assessed by questionnaire (PROMIS-HAQ)
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interaction of family carer with hip-fracture patient and health professionals
Time Frame: 12 months
The interaction will be assessed by semi-structured interviews with a family carer.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Zürich
University of Applied Sciences of Western Switzerland
Spitex Zürich, Switzerland
City of Zurich, Switzerland
Ebnet Stiftung, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heike Bischoff-Ferrari, Prof., Zentrum Alter und Mobilität

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-01820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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