Dementia Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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