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CompletedNCT00854438PRADAUpdated Jun 19, 2015

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

An interventional study of Multidisciplinary drug reviews by pharmacist and physician in Anticholinergic Side Effects, sponsored by Ullevaal University Hospital. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2015-06-19.

Sponsored by Ullevaal University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anticholinergic Side Effects

Keywords

  • anticholinergic drugs
  • adverse events
  • elderly
  • clinical pharmacist
  • Evaluate the clinical effects of reducing anticholinergic in elderly
03

In context

Lead sponsor

Ullevaal University Hospital is the lead sponsor of 76 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Not able to perform the testes because of physical or psychiatric illnesses.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    Active treatment arm

    Reduction of anticholinergic drug effects by pharmacist review

    Other: Multidisciplinary drug reviews by pharmacist and physician

  • No intervention
    Control

    No intervention

Interventions

  • OtherMultidisciplinary drug reviews by pharmacist and physician

    Reduction of anticholinergic drug effects by pharmacist review

06

What researchers measure

Primary outcomes

  1. CERADS word list measuring immediately and delayed recall

    Time frame: 4 years

Secondary outcomes

  1. Mouth dryness

    Time frame: 4 years

  2. ADL

    Time frame: 4 years

  3. Serum anticholinergic activity

    Time frame: 4 years

  4. CERADS word list recognition

    Time frame: 4 years

  5. MMSE

    Time frame: 4 years

  6. NPI

    Time frame: 4 years

07

Study locations

1 site
  • Ullevaal University Hospital
    Oslo, 0407, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00854438
Lead sponsor
Ullevaal University Hospital
Collaborators
South-Eastern Norway Regional Health Authority, Norwegian Directorate of Health
Responsible party
Torgeir Bruun Wyller (Professor, Oslo University Hospital) — Principal investigator
First posted
Mar 3, 2009
Start date
Sep 2008
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Jun 19, 2015

Study contacts

Torgeir B. Wyller, Professor
study director · Ullevaal University Hospital
Hege Kersten, MScPharm/PhD
principal investigator · Ullevaal University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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