Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000048684
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
26/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clear Mind Project
Scientific title
Promoting Physical Activity in Later Life: Impact on Memory and Mood
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive decline 117 0
Quality of life 118 0
Mood 119 0
Condition category
Condition code
Neurological 134 134 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Education of general practitioners about health promotion activity in later life
Intervention code [1] 60 0
None
Comparator / control treatment
No specific education
Control group
Active

Outcomes
Primary outcome [1] 169 0
Cognitive decline (CAMCOG)
Timepoint [1] 169 0
Primary outcome [2] 170 0
Changes in mood (BDI)
Timepoint [2] 170 0
Secondary outcome [1] 370 0
Change in quality of life scores (SF36).
Timepoint [1] 370 0
Secondary outcome [2] 371 0
Mood (BAI).
Timepoint [2] 371 0
Secondary outcome [3] 372 0
Memory (Logical Memory, Words List, Paired Associates, Faces - WMS-III; California Verbal Learning Test).
Timepoint [3] 372 0
Secondary outcome [4] 373 0
General cognitive function (MMSE).
Timepoint [4] 373 0

Eligibility
Key inclusion criteria
GPs working in the metropolitan area of Perth who have at least 20 adults aged 70+ in their practice
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Planning to move or discontinue practice during the study period, (2) consults only in language other than English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation organised and maintained centrally by academic not directly involved with the running of the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation (GP is the centre of cluster). Blocks. Random numbers generated by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
44
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 185 0
Government body
Name [1] 185 0
Healthway, WA
Country [1] 185 0
Australia
Primary sponsor type
Government body
Name
Healthway, WA
Address
Country
Australia
Secondary sponsor category [1] 138 0
Other
Name [1] 138 0
Healthway, WA
Address [1] 138 0
Country [1] 138 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 950 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 950 0
Ethics committee country [1] 950 0
Australia
Date submitted for ethics approval [1] 950 0
Approval date [1] 950 0
Ethics approval number [1] 950 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35651 0
Address 35651 0
Country 35651 0
Phone 35651 0
Fax 35651 0
Email 35651 0
Contact person for public queries
Name 9249 0
Prof. Osvaldo P. Almeida
Address 9249 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 9249 0
Australia
Phone 9249 0
+61 8 92242855
Fax 9249 0
Email 9249 0
osvalm@cyllene.uwa.edu.au
Contact person for scientific queries
Name 177 0
Prof. Osvaldo P. Almeida
Address 177 0
Unit of Geriatric Psychiatry
University of Western Australia
M573
35 Stirling Highway
Crawley WA 6009
Country 177 0
Australia
Phone 177 0
+61 8 92242855
Fax 177 0
Email 177 0
osvalm@cyllene.uwa.edu.au

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.