Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000018314
Ethics application status
Approved
Date submitted
10/01/2008
Date registered
14/01/2008
Date last updated
1/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Anticholinergic and sedative drug use and functional status among older Australians.
Scientific title
Can medication review using the drug burden index improve function in older Australians?
Secondary ID [1] 507 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication exposure in older adults. 2697 0
Physical and cognitive functioning in older adults. 2698 0
Condition category
Condition code
Mental Health 2814 2814 0 0
Studies of normal psychology, cognitive function and behaviour
Musculoskeletal 2815 2815 0 0
Normal musculoskeletal and cartilage development and function
Public Health 2816 2816 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug burden index is a tool used to quantify a person’s total exposure to anticholinergic and sedative medications. Drug burden index has been associated with physical and cognitive performance in older people. Drug burden index can be used to assess the risks and benefits of prescribing for older populations.
This project aims to test the validity of the drug burden index and its association with functional outcomes in an Australian population of older people living in retirement villages. It will also assess the feasibility of drug burden index as a prompt for medication review.
The intervention will be conducted over 3 months and it will involve prompting General Practitioners to reduce those drugs contributing to drug burden index and potentially impairing the patient’s physical and cognitive function.
For the intervention group, a report including list of medications associated with drug burden index will be sent to the General Practitioner for consideration of possible withdrawal (dose reduction or cessation). The report will quantify the degree of functional impairment that may be associated with the participant's drug burden.
For the control group, there will be no prompting about drug burden.
Intervention code [1] 2433 0
Treatment: Drugs
Comparator / control treatment
The control treatment is active. The control group will receive standard care from their General Practitioners. There will be no prompting about drug burden.
Control group
Active

Outcomes
Primary outcome [1] 3700 0
Exposure to medications with anticholinergic and sedative effects using the drug burden index.
Timepoint [1] 3700 0
At baseline and 3 months.
Primary outcome [2] 3701 0
Objective measures of physical and cognitive function.
Timepoint [2] 3701 0
At baseline and 3 months.
Secondary outcome [1] 6245 0
General practitioners' reasons for prescribing or withdrawing medications with sedative or anticholinergic effects.
Timepoint [1] 6245 0
After baseline interview.

Eligibility
Key inclusion criteria
People aged > 70 years who consult their general practitioners regularly who live in the participating retirement villages in Sydney, Australia.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to obtain informed consent from resident or legal caregiver.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Method of randomisation: Stratified allocation by centre.
Retirement villages will be randomised as intervention and control sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2008
Actual
29/02/2008
Date of last participant enrolment
Anticipated
Actual
10/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
115
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 719 0
2060
Recruitment postcode(s) [2] 720 0
2089

Funding & Sponsors
Funding source category [1] 2947 0
Charities/Societies/Foundations
Name [1] 2947 0
Geoff & Elaine Penney Aged Care Trust Fund
Country [1] 2947 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Geoff & Elaine Penney Aged Care Trust Fund
Address
Aged Care & Rehabilitation Department

Royal North Shore Hospital

Pacific Highway, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 2660 0
None
Name [1] 2660 0
Address [1] 2660 0
Country [1] 2660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4890 0
Northern Sydney Health Human Research Ethics Committee (Harbour)
Ethics committee address [1] 4890 0
The Research Office,
Level 4,

Vindin House

Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 4890 0
Australia
Date submitted for ethics approval [1] 4890 0
Approval date [1] 4890 0
13/12/2007
Ethics approval number [1] 4890 0
EC00333

Summary
Brief summary
The proposed study will provide important insight for identifying medications that may contribute to functional impairments and age related disability in older Australians.
This study aims to describe the exposure of older Australians to medications with sedative and anticholinergic effects using the Drug Burden Index. It will investigate the role of the drug burden index as a tool to guide prescribing in older Australians and whether changes drug burden are associated with changes in the physical and cognitive functional status.
Trial website
Trial related presentations / publications
The data will be used to write PhD thesis and will be presented through oral presentations at the University of Sydney and Royal North Shore Hospital.

Results may be published in medical journals and presented at scientific and medical conferences.
Public notes

Contacts
Principal investigator
Name 28286 0
Prof Sarah Hilmer
Address 28286 0
Level 12 Kolling Building
Royal North Shore Hospital and Kolling Medical Institute
St Leonards NSW 2065
Country 28286 0
Australia
Phone 28286 0
61 9926 4481
Fax 28286 0
Email 28286 0
[email protected]
Contact person for public queries
Name 11443 0
Prof Dr Sarah Hilmer
Address 11443 0
Clinical Pharmacology Department
11C Main Building RNSH
Pacific Highway, St Leonards, NSW 2065
Country 11443 0
Australia
Phone 11443 0
+61 2 9926 7631
Fax 11443 0
+61 2 9926 7614
Email 11443 0
[email protected]
Contact person for scientific queries
Name 2371 0
Prof Dr Sarah Hilmer
Address 2371 0
Clinical Pharmacology Department
11C Main Building RNSH
Pacific Highway, St Leonards, NSW 2065
Country 2371 0
Australia
Phone 2371 0
+61 2 9926 7631
Fax 2371 0
+61 2 9926 7614
Email 2371 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.