Delirium Clinical Trial
Official title:
Preventing Delirium in Hospitalized Elderly
Verified date | February 2008 |
Source | National Institute on Aging (NIA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
The purpose of this study is to explore the efficacy of a perioperative daily dose of Donepezil (a cholinergic enhancer) in reducing the incidence and severity of delirium.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2007 |
Est. primary completion date | April 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - Community-dwelling individuals aged 65 or older - Admitted to Methodist Hospital for surgical repair of hip fracture - No evidence of delirium at admission to hospital - MMSE total score below 24 points after adjustment for education and age - Consent to participate in the study Exclusion Criteria: - Severely demented as defined by MMSE score below 10 - Metastatic cancer or other comorbid illnesses likely to reduce life expectancy to under 6 months - Multiple trauma or pathological fractures - Aphasic, legally blind, or deaf - Use of Donepezil or other cholinesterase inhibitors within one month prior to surgery - Allergy to Donepezil |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Methodist Hospital, Clarian Health Partners | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University Health |
United States,
Barrett-Connor E. The economic and human costs of osteoporotic fracture. Am J Med. 1995 Feb 27;98(2A):3S-8S. Review. — View Citation
Cooper C, Campion G, Melton LJ 3rd. Hip fractures in the elderly: a world-wide projection. Osteoporos Int. 1992 Nov;2(6):285-9. — View Citation
Cummings SR, Rubin SM, Black D. The future of hip fractures in the United States. Numbers, costs, and potential effects of postmenopausal estrogen. Clin Orthop Relat Res. 1990 Mar;(252):163-6. — View Citation
Galanakis P, Bickel H, Gradinger R, Von Gumppenberg S, Förstl H. Acute confusional state in the elderly following hip surgery: incidence, risk factors and complications. Int J Geriatr Psychiatry. 2001 Apr;16(4):349-55. — View Citation
Gustafson Y, Berggren D, Brännström B, Bucht G, Norberg A, Hansson LI, Winblad B. Acute confusional states in elderly patients treated for femoral neck fracture. J Am Geriatr Soc. 1988 Jun;36(6):525-30. — View Citation
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative cumulative incident cases of delirium, as defined by the Confusion Assessment Method (CAM) administered at baseline prior to surgery and daily until discharge | |||
Primary | delirium severity as measured by the Memorial Delirium Assessment Scale (MDAS) | |||
Secondary | Cognitive status as measured by the Mini Mental Status Exam (MMSE) | |||
Secondary | behavioral status using the Rating Scale for Aggressive Behavior in the Elderly (RAGE) | |||
Secondary | length of stay in hospital postoperatively | |||
Secondary | discharge site | |||
Secondary | adverse effects | |||
Secondary | use of psychotropic medications |
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