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Geriatric AssessmentREFITNCT04777136

Home-visits From geRiatric tEam aFter hIp fracTure

A study testing Home visit and comprehensive geriatric assessment in people with Geriatric Assessment and Hip Fractures, run by Herlev Hospital at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of… Read more about this study

Who is it for?
Ages 70 to 120 years
Conditions the study is for
Geriatric Assessment, Hip Fractures, Frailty
What is being tested?
Home visit and comprehensive geriatric assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteDenmark
Study dates
1 Mar 2021to 28 Feb 2023
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age of 70 years or older
  • Hip fracture
  • Ability to provide informed consent
  • Residence in one of three following municipalities: Gladsaxe, Rudersdal or Lyngby-Taarbæk

Who cannot join

  • No ability to provide informed consent
  • Patients, who dies within 48 hours of discharge
  • Terminal patients
  • Nursing home residents

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Herlev and Gentofte hospital

    Herlev, Capital Region, 2730

Other trials in Denmark

About this study

Official title: The Effect of Home-visit Follow-up With a Multidisciplinary Geriatric Team in Old Patients With a Hip Fracture

The primary objective is to examine the effect of multidisciplinary geriatric team home-visits as follow-up after a hip fracture in old patients. The hypothesis is that home-visits will reduce the number of falls, readmissions, prevent functional decline, optimize that medical treatment, and a higher degree of satisfaction and quality of life.

Read the detailed description

Among older individuals, falling is a strong predictor of frailty, morbidity, and mortality and may cause a fracture. Many older patients experience recurrent falls, further functional decline, and readmission within the first three months. Hence, fall-related visits to the hospital represent a "red flag" but are also an opportunity for targeted intervention and prevention of future falls. However, many older patients are only treated for fall-related injuries and discharged without fall risk assessment or evaluation, hence there is a need for follow-up with targeted fall assessment and intervention to prevent further falls.

Thus, the present project aims to examine the effect of home-visit follow-up of older frail patients discharged from the orthopedic ward with a hip fracture. Furthermore, we will explore the effect of a cross-sectorial collaboration between hospital and municipality in the patients' homes to prevent falls, readmissions, medicine-associated adverse effects, and physical deconditioning in old frail patients.

The present study is a interventional trial. The intervention will consist of a home visit within ten weekdays of the discharge, where a comprehensive geriatric assessment (CGA) will be performed. The team performing the CGA consist of a Geriatrician and an experienced geriatric nurse. CGA is an overall assessment of the patient taking account of; the presence and severity of comorbidity, the nutritional state, cognitive and functional status, review of current medications, and social measures. The purpose is to stabilize and optimize current as well as chronic conditions, and reduce the probability of adverse events and falls, and to secure interventions or changes persist through the transition from the secondary to the primary health care system. The assessment may lead to several interventions, including; medicine review (new medicine, change in current or discontinuation), initiation of a nutritional effort or contact to a dietitian, referral to other health care services (outpatient clinics, hospitals, or general practitioner), referral to physiotherapy and/or occupational therapy or optimization of home care.

Patients randomized to the control group will receive standard care, where the subsequent need for medical service or increased home care will require contact with the general practitioner or the municipality, at the patient's initiative.

Being tested
Home visit and comprehensive geriatric assessment, Control group, no designated follow up
Keywords
Geriatric assesment, hip fracture, Home-visit, Old patients
Medical subject headings
Hip Fractures, Frailty, Atrophy

What participants receive

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

  • Home visit and comprehensive geriatric assessmentOther

    Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions

  • Control group, no designated follow upOther

    Only follow-up on patients own initiative with contact to the general practitioner

Study groups in NCT04777136
Study groupRoleWhat they receive
Geriatric home visitExperimentalHome-visit where a comprehensive geriatric assessment will be performed
Receives: Other: Home visit and comprehensive geriatric assessment
Standard careActive comparatorNo follow-up.
Receives: Other: Control group, no designated follow up

What is being measured

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

  1. Time to contact to the general practitioner or hospital because of a fall

    Fall-related contact for treatment or assessment

    Measured: 90 days

Secondary outcomes (17)
  1. Contacts to a doctor

    Number of contacts to a doctor (either hospital or the general practitioner)

    Measured: 90 days

  2. Contacts to a doctor

    Number of contacts to a doctor (either hospital or the general practitioner)

    Measured: 30 days

  3. Falls

    number of falls

    Measured: 30 days

  4. Falls

    number of falls

    Measured: 90 days

  5. Preventable readmissions

    Number of readmission deemed preventable by two blinded assessors

    Measured: 30 days

  6. Number of drugs

    Number of inappropriate drugs (Stop/Startt criteria)

    Measured: 30 days

  7. Quality of life

    Assessment of Quality of life using questionnaire (EQ VAS 0-100)

    Measured: 90 days

  8. Patient satisfaction and fear of falling

    Assessment patient satisfaction using questionnaire (Sat-UG-1)

    Measured: 30 days

  9. Patient satisfaction and fear of faling

    Assessment patient satisfaction using questionnaire (Sat-UG-1)

    Measured: 90 days

  10. All cause mortaliy

    Mortality

    Measured: 30 days

  11. All cause mortaliy

    Mortality

    Measured: 90 days

  12. Muscle strength

    Measured using "timed-up-and-go" test

    Measured: 90 days

  13. Mobility

    Assessed using the "new mobility score" (0-10, high is good)

    Measured: 90 days

  14. Mobility

    Assessed using the "Cumulated Ambulation Score" (0-6, high is good)

    Measured: 90 days

  15. Weight

    Change in weight i kilograms from discharge "Cumulated Ambulation Score", and "new mobility score"

    Measured: 90 days

  16. Independence

    Number of patients using walking aids

    Measured: 90 days

  17. Independence

    Number of patients with a new placement at a nursing homes

    Measured: 90 days

Timeline

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

  1. First posted2 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Apr 2022
  4. Study completion28 Feb 2023 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Home visit from the geriatric team
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04777136
Sponsor's protocol ID
HgH_UGT_01
Acronym
REFIT
Status last verified
May 2022
First submitted
16 Feb 2021
Last updated
20 May 2022
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 Home visit and comprehensive geriatric assessment in people with Geriatric Assessment and Hip Fractures, run by Herlev Hospital at 1 site in Denmark.

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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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 Denmark. 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?

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?

Time to contact to the general practitioner or hospital because of a fall (time frame: 90 days). 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 20 May 2022.

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