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Completed

NCT Number: NCT00854438

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

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.

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Key information

Conditions

Anticholinergic Side Effects

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ullevaal University Hospital

Oslo, 0407, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multidisciplinary drug reviews by pharmacist and physician

Other

Reduction of anticholinergic drug effects by pharmacist review

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

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • Norwegian Directorate of Health
  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

Pharmacist-initiated Reduction of Anticholinergic Drug Activity

Acronym: PRADA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 3, 2009
Registry last updated
Jun 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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