Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-02-28

Brief Summary

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Delirium (acute confusion) is a highly prevalent condition among hospitalized elders with substantial morbidity within the hospital and beyond. Particular patient populations are at high risk for poor outcomes after an episode of delirium. Patients with hip and other long bone fractures are at increased risk of developing delirium (acute confusion) which impedes functional recovery. This is a pilot study to test the tolerability and efficacy of donepezil, a cholinesterase inhibitor medication used commonly in persons with dementia, for the prevention of new or worsening delirium in aged hip and other long-bone fracture patients. Additional purposes involve gathering a small amount of patients' serum to better understand the pathophysiology of delirium in this population.

The purposes of this pilot study are to determine: 1) the safety and tolerability a cholinesterase inhibitor medication) in aged hip and long bone fracture patients, 2) To obtain estimates of subject accrual and preliminary estimates of effect size on the development of new delirium symptoms to allow for planning of a larger, definitive trial, 3) To better understand the underlying causes of delirium by examining whether a measure of blood anticholinergic activity relates to the incidence and persistence of delirium symptoms, and 4) To explore the interaction between anticholinergic activity, donepezil therapy, and delirium symptoms.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

5 mg each day for 30 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Encapsulated cornstarch One capsule daily for 30 days

Interventions

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donepezil

5 mg each day for 30 days

Intervention Type DRUG

Placebo

Encapsulated cornstarch One capsule daily for 30 days

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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Inclusion Criteria

* hip or other long bone fracture undergoing operative repair
* age of 70 years or older
* the ability to communicate effectively in English (including adequate hearing)
* residence within a 50 mile radius of the BIDMC
* life expectancy 6 months or greater
* not currently on cholinesterase inhibitor therapy
* not with known hypersensitivity to cholinesterase inhibitors
* not a previous study participant or refusal

Exclusion Criteria

* patients with sick sinus syndrome or greater than 1st degree AV block without a pacemaker
* patients with a pathologic fracture due to metastatic cancer
* patients with advanced dementia or total functional dependence.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No