The Effect of a Pre- and Postoperative Orthogeriatric Service
Primary Purpose
Dementia, Delirium
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Orthogeriatric intervention
Sponsored by
About this trial
This is an interventional treatment trial for Dementia
Eligibility Criteria
Inclusion Criteria:
• Eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.
Exclusion Criteria:
- 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.
Sites / Locations
- Oslo University Hospital, Ullevaal
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Activities of Daily Living (ADL) Scale
Nottingham Extended Activities of Daily Living (NEADL) scale
Intrahospital mortality
Cumulative mortality
The Short Physical Performance Battery (SPPB) scale
Pre-/postoperative delirium
Duration/Severity of delirium
Other complications
Incidence of dementia 12 months postoperatively
Length of hospital stay
Markers of bone turnover
Micronutrients in blood
Full Information
NCT ID
NCT01009268
First Posted
November 5, 2009
Last Updated
May 15, 2013
Sponsor
Ullevaal University Hospital
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT01009268
Brief Title
The Effect of a Pre- and Postoperative Orthogeriatric Service
Official Title
The Effect of a Pre- and Postoperative Orthogeriatric Service. A Randomised, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ullevaal University Hospital
Collaborators
The Research Council of Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Delirium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Orthogeriatric intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Activities of Daily Living (ADL) Scale
Time Frame
4 and 12 months
Title
Nottingham Extended Activities of Daily Living (NEADL) scale
Time Frame
4 and 12 months
Title
Intrahospital mortality
Time Frame
4 and 12 months
Title
Cumulative mortality
Time Frame
4 and 12 months
Title
The Short Physical Performance Battery (SPPB) scale
Time Frame
4 and 12 months
Title
Pre-/postoperative delirium
Time Frame
4 and 12 months
Title
Duration/Severity of delirium
Time Frame
4 and 12 months
Title
Other complications
Time Frame
4 and 12 months
Title
Incidence of dementia 12 months postoperatively
Time Frame
4 and 12 months
Title
Length of hospital stay
Time Frame
4 and 12 months
Title
Markers of bone turnover
Time Frame
4 months
Title
Micronutrients in blood
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Eligible patients will be admitted acutely for a femoral neck fracture, a trochanteric or a subtrochanteric femoral fracture.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir Bruun Wyller, MD, Prof.
Organizational Affiliation
University of Oslo, Fac of Med., Geriatric dep.
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital, Ullevaal
City
Oslo
ZIP/Postal Code
0407 OSLO
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
34766330
Citation
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.
Results Reference
derived
PubMed Identifier
30661701
Citation
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.
Results Reference
derived
PubMed Identifier
26795217
Citation
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.
Results Reference
derived
PubMed Identifier
24735588
Citation
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.
Results Reference
derived
PubMed Identifier
22817102
Citation
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.
Results Reference
derived
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The Effect of a Pre- and Postoperative Orthogeriatric Service
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