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| Descriptive Information Fields | |||||
| Brief Title † | A Trial to Reduce Delirium in Aged Post Acute Patients | ||||
| Official Title † | A Trial to Reduce Delirium in Aged Post Acute Patients | ||||
| Brief Summary | The purpose of this study is to develop a comprehensive Delirium Abatement Program of care of delirious patients in the post acute care setting and to evaluate its impact on persistence and severity of delirium and on functional recovery. |
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| Detailed Description | Common, morbid, and costly, delirium affects one third of hospitalized elders, and plays a central role in the cascade of adverse events that leads to functional decline and loss of independence. Moreover, as acute care stays continue to shorten and evidence mounts that delirium may persist for many weeks, concern about delirium can no longer be confined to the hospital. It is believed that a Delirium Abatement Program may significantly reduce the persistence of delirium in post-acute settings, and thereby improve functional recovery both during the post-acute stay and after discharge. The Delirium Abatement Program (DAP) will be designed to assist facility staff to 1) detect delirium among new admissions, 2) evaluate common underlying causes of delirium, 3) prevent complications commonly associated with delirium, and 4) restore delirious patients' cognitive, behavioral, social and self care functioning to baseline status. This three year trial will enroll 500 delirious patients admitted to eight Boston area post-acute skilled nursing facilities. The DAP intervention will be carried out in four facilities. Four other facilities, matched to the intervention by demographic, facility, and clinical characteristics, will serve as controls. Patients will be recruited within 72 hours (maximum 120 hrs) of admission, assessed weekly while in the facility, and at one, three, and six months following admission. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Prevalence of delirium at two weeks after admission Activities of Daily Living (ADL) functional improvement two weeks after admission Full ADL functional recovery to pre-illness status three months after post-acute admission |
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| Secondary Outcome Measure † | Examination of differences between patients in facilities receiving the Delirium Abatement Program and those not on additional outcomes of delirium persistence and ADL improvement one month following admission Differences in delirium severity, length of post acute stay, and health care resource utilization |
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| Condition † | Delirium Aging |
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| Intervention † | Behavioral: Delirium Abatement Program | ||||
| MEDLINE PMIDs | 12534838, 15935018, 16979083, 16181185, 2644535, 10855596, 1739363 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 500 | ||||
| Start Date † | May 2000 | ||||
| Completion Date | June 2004 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00182936 | ||||
| Organization ID | AG0040 | ||||
| Secondary IDs †† | AG17649 | ||||
| Study Sponsor † | National Institute on Aging (NIA) | ||||
| Collaborators †† | Paul B. Beeson Career Development Awards in Aging Research Program | ||||
| Investigators † |
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| Information Provided By | National Institute on Aging (NIA) | ||||
| Verification Date | November 2006 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | November 16, 2006 | ||||
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