AzTrials
AzTrials

DementiaNCT01009268

The Effect of a Pre- and Postoperative Orthogeriatric Service

A study testing Orthogeriatric intervention in people with Dementia and Delirium, run by Ullevaal University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study. The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome. Read more about this study

Who is it for?
Any age
Conditions the study is for
Dementia, Delirium
What is being tested?
Orthogeriatric intervention
Type of treatment
Surgery or procedure
How many people
332 participants
Where
1 siteNorway
Study dates
Sep 2009to Dec 2012
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.

Who cannot join

  • Hip fracture as part of multi-trauma or high energy trauma (defined as a fall from a higher level than 1 metre). One recent fracture in addition to the hip fracture (e.g. radius or shoulder) is acceptable.
  • Regarded as moribund at admittance.
  • Absence of a valid informed consent or assent.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital, Ullevaal

    Oslo, 0407 OSLO

Other trials in Norway

About this study

Official title: The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial

The investigators' aim is to assess the effect of a model of preoperative as well as early postoperative care, treatment and rehabilitation in a dedicated orthogeriatric ward in a single-blind randomised study.

The investigators' main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome.

Read the detailed description

The study will be carried out in close cooperation between the Orthopaedic Centre and the Department of Geriatric Medicine. The patients will be randomized in the Emergency Department in accordance with procedures already established for a recently finished trial. The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.

The primary endpoint is chosen in order to optimize clinical relevance as well as sensitivity to change within a wide range of functional performance, and will be recorded four months after the fracture. Our main hypothesis is that an orthogeriatric service may improve long-time cognitive outcome. Accordingly, we will use a composite endpoint tapping cognitive functioning in the lower as well as the higher spectre of performance by these two instruments:

  • Clinical Dementia Rating Scale (CDR), proxy-based scale for severity of dementia, that is able to detect differences also between patients with severe dementia. The scale consists of six questions, each rated 0-3, adding up to a sumscore of 0-18 ("sum of boxes"). The scale is frequently used in dementia treatment trials, and is shown to be valid and reliable. CDR will be scored based on the best available source (relative, staff in nursing home or home nursing service)
  • The 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD). This test is shown to be sensitive for memory changes in persons that have a good or fairly good cognitive functioning. We will use the immediate recall and the delayed recall parts of this task, i.e. two scales.

The primary endpoint will be assessed after four months, by a specially trained research assistant blinded to allocation. The patients will be re-assessed after 12 months.

Conditions
Dementia, Delirium
Being tested
Orthogeriatric intervention
Medical subject headings
Dementia, Delirium

What participants receive

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

  • Orthogeriatric interventionProcedure or surgery

    The intervention group will be transferred as soon as possible to the orthogeriatric ward, stabilised there preoperatively, and transferred back to the same ward postoperatively for further treatment and rehabilitation, while the control group will be treated in a traditional orthopaedic ward. Operative and anaesthesiologic procedures will be the same in the two groups.Clinical routines for the orthogeriatric service has been developed during the pilot phase in 2008 and 2009, and are documented in the electronic library of clinical handbooks at Department of Geriatric Medicine.

What is being measured

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

  1. We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD)

    Measured: 4 and 12 months

Secondary outcomes (12)

  1. Activities of Daily Living (ADL) Scale

    Measured: 4 and 12 months

  2. Nottingham Extended Activities of Daily Living (NEADL) scale

    Measured: 4 and 12 months

  3. Intrahospital mortality

    Measured: 4 and 12 months

  4. Cumulative mortality

    Measured: 4 and 12 months

  5. The Short Physical Performance Battery (SPPB) scale

    Measured: 4 and 12 months

  6. Pre-/postoperative delirium

    Measured: 4 and 12 months

  7. Duration/Severity of delirium

    Measured: 4 and 12 months

  8. Other complications

    Measured: 4 and 12 months

  9. Incidence of dementia 12 months postoperatively

    Measured: 4 and 12 months

  10. Length of hospital stay

    Measured: 4 and 12 months

  11. Markers of bone turnover

    Measured: 4 months

  12. Micronutrients in blood

    Measured: 4 months

Timeline

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

  1. First posted6 Nov 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2012
  4. Study completionDec 2012

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01009268
Sponsor's protocol ID
1361
Status last verified
May 2013
First submitted
5 Nov 2009
Last updated
16 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.

    PubMed 34766330

  • Torbergsen AC, Watne LO, Frihagen F, Wyller TB, Mowe M. Effects of nutritional intervention upon bone turnover in elderly hip fracture patients. Randomized controlled trial. Clin Nutr ESPEN. 2019 Feb;29:52-58. doi: 10.1016/j.clnesp.2017.11.012. Epub 2018 Oct 30.

    PubMed 30661701

  • Torbergsen AC, Watne LO, Wyller TB, Frihagen F, Stromsoe K, Bohmer T, Mowe M. Micronutrients and the risk of hip fracture: Case-control study. Clin Nutr. 2017 Apr;36(2):438-443. doi: 10.1016/j.clnu.2015.12.014. Epub 2015 Dec 23.

    PubMed 26795217

  • Watne LO, Torbergsen AC, Conroy S, Engedal K, Frihagen F, Hjorthaug GA, Juliebo V, Raeder J, Saltvedt I, Skovlund E, Wyller TB. The effect of a pre- and postoperative orthogeriatric service on cognitive function in patients with hip fracture: randomized controlled trial (Oslo Orthogeriatric Trial). BMC Med. 2014 Apr 15;12:63. doi: 10.1186/1741-7015-12-63.

    PubMed 24735588

  • Wyller TB, Watne LO, Torbergsen A, Engedal K, Frihagen F, Juliebo V, Saltvedt I, Skovlund E, Raeder J, Conroy S. The effect of a pre- and post-operative orthogeriatric service on cognitive function in patients with hip fracture. The protocol of the Oslo Orthogeriatrics Trial. BMC Geriatr. 2012 Jul 20;12:36. doi: 10.1186/1471-2318-12-36.

    PubMed 22817102

Questions about this trial

What is this clinical trial studying?

A study testing Orthogeriatric intervention in people with Dementia and Delirium, run by Ullevaal University Hospital at 1 site in Norway.

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 1 inclusion and 3 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: finished, as of the sponsor's last update on 16 May 2013. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (time frame: 4 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01009268, which also lists 5 linked publications.

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 16 May 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in