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Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period (SHARP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Edward Marcantonio, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00586196
First received: December 21, 2007
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Delirium
Drug: donepezil
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Supporting the Health of Adults Undergoing Orthopedic Surgery During the Recovery Period

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Percentage of Participants With Delirium Using the CAM Over Time [ Time Frame: Baseline, hospital interviews, weeks 2, 4 and 6 ] [ Designated as safety issue: Yes ]
    Confusion Assessment Method (CAM)—Measure of the presence or absence of delirium. Requires 1) acute change with fluctuating course, 2) inattention, and either 3) disorganized thinking or 4) altered level of consciousness.


Secondary Outcome Measures:
  • Change From Baseline and MDAS Scores Over Time [ Time Frame: Baseline, hospital discharge, weeks 2, 4 and 6 ] [ Designated as safety issue: No ]
    Measures severity of 10 delirium symptoms items (0 not present, 1 mild, 2 moderate, 3 severe) yielding a total score of 0 to 30, with 30 most severe.


Enrollment: 16
Study Start Date: January 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: donepezil
5 mg each day for 30 days
Other Name: Aricept
Placebo Comparator: 2 Drug: Placebo
Encapsulated cornstarch One capsule daily for 30 days

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586196

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Edward R Marcantonio, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Edward Marcantonio, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00586196     History of Changes
Other Study ID Numbers: 2006p-000193, R21AG027549
Study First Received: December 21, 2007
Results First Received: February 28, 2013
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Delirium
Postoperative confusion
Hip fracture
Long bone fracture

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014