Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000247572
Ethics application status
Approved
Date submitted
13/06/2006
Date registered
20/06/2006
Date last updated
20/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose Administration Aids (DAAs) study
Scientific title
A Randomised controlled trial to measure the effectivess of Dose Administration Aids (DAAs) in improving veteran adherence and health outcomes and to characterise which veterans have a beneficial outcome.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor adherence and multiple mediction use 1226 0
Condition category
Condition code
Other 1309 1309 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involved the veteran's Local Medical Officer (LMO) prescribing a DAA in which the veteran's pharmacy packed and dispensed the veteran's medication for the 12 months of the intervention phase.
Intervention code [1] 1139 0
Other interventions
Comparator / control treatment
Control group veterans recieved thier medication in the original packaging as per usual care.
Control group
Active

Outcomes
Primary outcome [1] 1790 0
Change in GP rated severity of illness
Timepoint [1] 1790 0
Measured at baseline, 3 months, 6 months and 12 months.
Secondary outcome [1] 3146 0
Change in adherence and number of medications found in the home.
Timepoint [1] 3146 0
Measured at baseline, 3 months, 6 months and 12 months (measured by GP rating, self-report and pill-count).

Eligibility
Key inclusion criteria
(i) Australian veteran or war widow(er)s living in the community; (ii) receiving more than five medicines everyday; or (iii) having three or more concurrent medical conditions. Participation restricted to veterans who are willing to use just one local medical officer (LMO) and one community pharmacy for the duration of the trial and whose LMO and community pharmacy are willing to participate.
Minimum age
39 Years
Maximum age
97 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In a addition veterans were excluded if they were already using a DAA, were residing in an aged care facility or were participating in other studies with similar aims.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed by central randomisation by computer after completing baseline data collection
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated numbering sequence to recieve a DAA or usual care
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1435 0
Government body
Name [1] 1435 0
Commonwealth Department of Veterans' Affairs
Country [1] 1435 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Quality Medication Care Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 1269 0
University
Name [1] 1269 0
Therapeutics Research Unit, University of Queensland
Address [1] 1269 0
Country [1] 1269 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2808 0
The Princess Alexandra Hospital Research Ethics Committee
Ethics committee address [1] 2808 0
Ethics committee country [1] 2808 0
Australia
Date submitted for ethics approval [1] 2808 0
Approval date [1] 2808 0
Ethics approval number [1] 2808 0
169/99
Ethics committee name [2] 2809 0
University of Queensland Human Ethics Committee
Ethics committee address [2] 2809 0
Ethics committee country [2] 2809 0
Australia
Date submitted for ethics approval [2] 2809 0
Approval date [2] 2809 0
Ethics approval number [2] 2809 0
H/282/MED/00
Ethics committee name [3] 2810 0
Department of Veterans' Affairs Ethics Committee
Ethics committee address [3] 2810 0
Ethics committee country [3] 2810 0
Australia
Date submitted for ethics approval [3] 2810 0
Approval date [3] 2810 0
27/07/2000
Ethics approval number [3] 2810 0

Summary
Brief summary
The goal of the trial was to determine whether Dose Administration Aids improve veteran outcomes and to characterise which veterans will benefit most from using a DAA. A randomised controlled trial with one year's follow-up was conducted involving Australian war veterans and war widow/ers from selected rural and urban areas of New South Wales, Victoria, Queensland, South Australia and Tasmania. Veterans were randomly allocated to have thier medication packed in a DAA by thier community pharmacy (intervention arm) or to recieve thier medication in the original packaging (control). Due to the nature of the intervention it was not possible to blind participants to the study conditions. The main outcomes were change in severity of illness and adherence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35765 0
Address 35765 0
Country 35765 0
Phone 35765 0
Fax 35765 0
Email 35765 0
Contact person for public queries
Name 10328 0
Narelle Walker
Address 10328 0
Therapeutics Research Unit,
University of Queensland,
Princess Alexandra Hospital
Ipswich Rd, Woolloongabba QLD 4102
Country 10328 0
Australia
Phone 10328 0
+61 7 32405803
Fax 10328 0
+61 7 32405806
Email 10328 0
[email protected]
Contact person for scientific queries
Name 1256 0
Clare Ientile
Address 1256 0
Therapeutics Research Unit
University of Queensland
Princess Alexandra Hospital
Ipswich Rd Woolloongabba QLD 4102
Country 1256 0
Australia
Phone 1256 0
+61 7 32405803
Fax 1256 0
Email 1256 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.