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OsteoporosisSTARKNCT03154684

Spitex-SpiTal-Autonomie-Reha-Kraft

A study testing STARK intervention in people with Osteoporosis and Frailty, run by University of Zurich at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Osteoporosis, Frailty, Hip Fractures
What is being tested?
STARK intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteSwitzerland
Study dates
5 May 2017to 15 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Dept. of Geriatrics and Aging Research, University of Zurich / Geriatric Clinic University Hospital Zurich

    Zurich, Canton of Zurich, 8037

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
STARK intervention, Standard of Care
Keywords
Autonomy, Rehabilitation, Falls, Quality of life, Senior
Medical subject headings
Osteoporosis, Frailty, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STARK interventionOther

    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 CareOther

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

Study groups in NCT03154684
Study groupRoleWhat they receive
STARK interventionActive comparatorNew care concept for hip fracture patients
Receives: Other: STARK intervention
Standard CareOtherSwiss standard of care for hip fracture patients
Receives: Other: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower extremity function

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

    Measured: 12 months

Secondary outcomes (17)
  1. Gait speed

    Gait speed will be obtained from the SPPB.

    Measured: 12 months

  2. Gait speed

    Gait speed will be assessed by a 400 m walk test.

    Measured: 12 months

  3. Grip strength

    Hand grip strength will be measured using a Martin Vigorimeter.

    Measured: 12 months

  4. Repeated sit-to-stand

    Repeated chair stand test will be obtained from the SPPB.

    Measured: 12 months

  5. Rate of falls

    Rate of falls will be assessed by a monthly phone call.

    Measured: 12 months

  6. Health care utilization

    Health care utilization will be assessed using the health care utilization questionnaire.

    Measured: 12 months

  7. Number of re-hospitalizations

    All hospitalizations will be documented as part of the safety documentation(SAE).

    Measured: 12 months

  8. Number of nursing home admissions

    All nursing home admissions will be documented.

    Measured: 12 months

  9. Adherence to preventive strategies

    Adherence will be documented by the Spitex staff.

    Measured: 3 months

  10. Adherence to preventive strategies

    Adherence will be documented by an adherence questionnaire.

    Measured: 12 months

  11. Quality of life

    Quality of life will be assessed by the RAND SF-36 questionnaire.

    Measured: 12 months

  12. Quality of life

    Quality of life will be assessed by the EuroQol (EQ-5D-3L) questionnaire.

    Measured: 12 months

  13. Cognitive function

    Cognitive function will be assessed by the MoCA.

    Measured: 12 months

  14. Cognitive function

    Cognitive function will be assessed by the MMSE.

    Measured: 12 months

  15. Appendicular muscle mass

    Appendicular muscle mass will be assessed by dual energy X-ray absorptiometry.

    Measured: 12 months

  16. Bone mineral density

    Bone mineral density will be assessed by dual energy X-ray absorptiometry.

    Measured: 12 months

  17. Activities of daily living

    Activities of daily living will be assessed by questionnaire (PROMIS-HAQ)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start5 May 2017
  3. Primary completion15 Aug 2021
  4. Study completion15 Aug 2021

Why it stopped: Insufficient Recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03154684
Sponsor's protocol ID
2016-01820
Other IDs
2016
Acronym
STARK
Status last verified
Aug 2021
First submitted
4 May 2017
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing STARK intervention in people with Osteoporosis and Frailty, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient Recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower extremity function (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

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