Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes - Full Text View

Sponsors and Collaborators:	Ullevaal University Hospital South-Eastern Norway Regional Health Authority Norwegian Directorate of Health Societas Pharmaciae Norvegica
Information provided by:	Ullevaal University Hospital
ClinicalTrials.gov Identifier:	NCT00854438

Purpose

Thesis: Is drug-induced anticholinergic activity additive resulting in a total anticholinergic load causing harmful side effects in old, fragile patients? Is it possible to reduce the anticholinergic load by multidisciplinary medical review including a pharmacist and a physician? The effects of the medical reviews are measured by cognitive tests (MMS and CERADS word lists), a measure of mouth dryness, serum levels of anticholinergic activity, activity of daily living and neuropsychiatric symptoms.

Design: A randomized, controlled, single blinded interventional study in Norwegian nursing homes.

Condition	Intervention
Anticholinergic Side Effects	Other: Multidisciplinary drug reviews by pharmacist and physician

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Pharmacist-Initiated Reduction of Anticholinergic Drug Activity

Resource links provided by NLM:

MedlinePlus related topics: Nursing Homes

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

CERADS word list measuring immediately and delayed recall [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Mouth dryness [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
ADL [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Serum anticholinergic activity [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
CERADS word list recognition [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
MMSE [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
NPI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Reduction of drug-induced anticholinergic burden

Detailed Description:

Several studies have claimed that drugs showing anticholinergic activity in vitro cause high levels of serum anticholinergic activity in vivo that might cause impaired cognitive and functional functions in elderly.

Pathophysiological changes in Alzheimer`s dementia makes these patients particularly vulnerable for anticholinergic cognitive impairments. The PRADA-study is the first interventional study evaluating the clinical effects of reducing drug-induced anticholinergic load in patients with dementia. This is also the first interventional study in the Nordic countries evaluating the clinical effects of clinical pharmacy.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Long-term nursing home patients with none, mild or moderate dementia (evaluated by CDR9,using drugs with a total anticholinergic burden that might lead to adverse events.

Exclusion Criteria:

Not able to perform the testes because of physical or psychiatric illnesses.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854438

Locations

Norway
Ullevaal University Hospital
Oslo, Norway, 0407

Sponsors and Collaborators

Ullevaal University Hospital

South-Eastern Norway Regional Health Authority

Norwegian Directorate of Health

Societas Pharmaciae Norvegica

Investigators

Study Director:	Torgeir B. Wyller, Professor	Ullevaal University Hospital
Principal Investigator:	Hege Kersten, MScPharm/PhD	Ullevaal University Hospital

More Information

No publications provided

Responsible Party:	Ullevaal University Hospital, dep of geriatric medicine ( Prof. Torgeir Bruun Wyller )
Study ID Numbers:	1110
Study First Received:	February 23, 2009
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00854438 History of Changes
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Ullevaal University Hospital:

anticholinergic drugs
adverse events
elderly
clinical pharmacist
Evaluate the clinical effects of reducing anticholinergic in elderly

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Cholinergic Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009