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Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes (PRADA)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
South-Eastern Norway Regional Health Authority
Norwegian Directorate of Health
Societas Pharmaciae Norvegica
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00854438
First received: February 23, 2009
Last updated: March 7, 2011
Last verified: March 2011
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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 Oslo 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)
Arms Assigned Interventions
Experimental: Active treatment arm
Reduction of anticholinergic drug effects by pharmacist review
 Other: Multidisciplinary drug reviews by pharmacist and physician
Reduction of anticholinergic drug effects by pharmacist review
No Intervention: Control
No intervention

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: Prof. Torgeir Bruun Wyller, Ullevaal University Hospital, dep of geriatric medicine
ClinicalTrials.gov Identifier: NCT00854438     History of Changes
Other Study ID Numbers: 1110
Study First Received: February 23, 2009
Last Updated: March 7, 2011
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Oslo University Hospital:
anticholinergic drugs
adverse events
elderly
clinical pharmacist
Evaluate the clinical effects of reducing anticholinergic in elderly

Additional relevant MeSH terms:
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013