Reduction of Adverse Events of Anticholinergic Drugs by M... | NCT00854438

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

NCT00854438

Sponsor

Ullevaal University Hospital

Status

Completed

Last Update Posted

Jun 19, 2015Estimated

Enrollment

87Actual

Phase

Not Applicable

Conditions

Anticholinergic Side Effects

Interventions

Multidisciplinary drug reviews by pharmacist and physician

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Feb 23, 2009

First Submission Date that Met QC Criteria

Mar 2, 2009

First Posted Date

Mar 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2015

Last Update Posted Date

Jun 19, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Torgeir Bruun Wyller, Professor, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Ullevaal University HospitalOTHER

Collaborators

Name	Class
South-Eastern Norway Regional Health Authority	OTHER
Norwegian Directorate of Health	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active treatment arm	Experimental	Reduction of anticholinergic drug effects by pharmacist review	Other: Multidisciplinary drug reviews by pharmacist and physician
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multidisciplinary drug reviews by pharmacist and physician	Other	Reduction of anticholinergic drug effects by pharmacist review	Active treatment arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Mouth dryness		4 years
ADL		4 years
Serum anticholinergic activity

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Torgeir B. Wyller, Professor	Ullevaal University Hospital	Study Director
Hege Kersten, MScPharm/PhD	Ullevaal University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ullevaal University Hospital		Oslo	Oslo	0407	Norway

Intervention Browse Module

MeSH Terms

ID	Term
D010820	Physicians

Ancestor Terms

ID	Term
D006282	Health Personnel
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided