Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes
PRADA
Pharmacist-initiated Reduction of Anticholinergic Drug Activity
1 other identifier
interventional
87
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedJune 19, 2015
June 1, 2015
1 year
February 23, 2009
June 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CERADS word list measuring immediately and delayed recall
4 years
Secondary Outcomes (6)
Mouth dryness
4 years
ADL
4 years
Serum anticholinergic activity
4 years
CERADS word list recognition
4 years
MMSE
4 years
- +1 more secondary outcomes
Study Arms (2)
Active treatment arm
EXPERIMENTALReduction of anticholinergic drug effects by pharmacist review
Control
NO INTERVENTIONNo intervention
Interventions
Reduction of anticholinergic drug effects by pharmacist review
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not able to perform the testes because of physical or psychiatric illnesses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ullevaal University Hospitallead
- South-Eastern Norway Regional Health Authoritycollaborator
- Norwegian Directorate of Healthcollaborator
Study Sites (1)
Ullevaal University Hospital
Oslo, Oslo County, 0407, Norway
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Torgeir B. Wyller, Professor
Ullevaal University Hospital
- PRINCIPAL INVESTIGATOR
Hege Kersten, MScPharm/PhD
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 23, 2009
First Posted
March 3, 2009
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
June 19, 2015
Record last verified: 2015-06