Reduction of Adverse Events of Anticholinergic Drugs by Multidisciplinary Medical Reviews in Norwegian Nursing Homes
- Conditions
- Anticholinergic Side Effects
- Interventions
- Other: Multidisciplinary drug reviews by pharmacist and physician
- Registration Number
- NCT00854438
- Lead Sponsor
- Ullevaal University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
- 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.
- Not able to perform the testes because of physical or psychiatric illnesses.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active treatment arm Multidisciplinary drug reviews by pharmacist and physician Reduction of anticholinergic drug effects by pharmacist review
- Primary Outcome Measures
Name Time Method CERADS word list measuring immediately and delayed recall 4 years
- Secondary Outcome Measures
Name Time Method ADL 4 years Serum anticholinergic activity 4 years NPI 4 years CERADS word list recognition 4 years MMSE 4 years Mouth dryness 4 years
Trial Locations
- Locations (1)
Ullevaal University Hospital
🇳🇴Oslo, Norway