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

June 18, 2015 updated by: Torgeir Bruun Wyller, Ullevaal University Hospital

Pharmacist-initiated Reduction of Anticholinergic Drug Activity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
No intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CERADS word list measuring immediately and delayed recall
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mouth dryness
Time Frame: 4 years
4 years
ADL
Time Frame: 4 years
4 years
Serum anticholinergic activity
Time Frame: 4 years
4 years
CERADS word list recognition
Time Frame: 4 years
4 years
MMSE
Time Frame: 4 years
4 years
NPI
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Collaborators

South-Eastern Norway Regional Health Authority
Norwegian Directorate of Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

February 23, 2009

First Submitted That Met QC Criteria

March 2, 2009

First Posted (ESTIMATE)

March 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2015

Last Update Submitted That Met QC Criteria

June 18, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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