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

Anticholinergic Side Effects Clinical Trial

— PRADA  

Official title:

Pharmacist-initiated Reduction of Anticholinergic Drug Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854438
• Other study ID #: 1110
• Status: Completed
• Phase: N/A
• First received: February 23, 2009
• Last updated: June 18, 2015
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: June 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anticholinergic Side Effects

Intervention

Other:
• Multidisciplinary drug reviews by pharmacist and physician
Reduction of anticholinergic drug effects by pharmacist review

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Directorate of Health, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CERADS word list measuring immediately and delayed recall		4 years	Yes
Secondary	Mouth dryness		4 years	Yes
Secondary	ADL		4 years	Yes
Secondary	Serum anticholinergic activity		4 years	Yes
Secondary	CERADS word list recognition		4 years	Yes
Secondary	MMSE		4 years	Yes
Secondary	NPI		4 years	Yes