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Trial registered on ANZCTR


Registration number
ACTRN12612000359831
Ethics application status
Approved
Date submitted
27/03/2012
Date registered
28/03/2012
Date last updated
28/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Computer Based Rehabilitation of Cognition in healthy elderly participants.
Scientific title
Cognitive training for rehabilitation of the healthy elderly: a randomized wait list control group
Secondary ID [1] 280227 0
Nil
Universal Trial Number (UTN)
U1111-1129-4448
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 286174 0
Condition category
Condition code
Neurological 286369 286369 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In order to assessed the efficacy of cognitive training program, a computerized software (COGPACK) were used. The training consists of attention, executive function, visual spatial working memory and processing speed training derived from Cogpack training content. The training was conducted individually 2 to 3 hours a day over 4 weeks. The participants were required to complete each session between 2 hours to 3 hours depending on their ability. Participants were introduced to the use of computers and mild assistance was given if they have any difficulties with computer training. The training program was supervised by a trained clinical psychologist.
Intervention code [1] 284560 0
Rehabilitation
Intervention code [2] 284570 0
Behaviour
Intervention code [3] 284571 0
Prevention
Comparator / control treatment
Wait-list control group. Both group will attend the training program. Immediate group will access to training immediately after the baseline assessment meanwhile the wait list group had to wait for a month before attending training program.
Control group
Active

Outcomes
Primary outcome [1] 286824 0
The primary outcomes is based on improvement in cognition after training and whether it is maintained at 3 month follow-up. The outcomes will be based on scores on a battery of psychological assessment that involved a multiple cognitive areas. The improvement will also be measured on the result in electrophysiological indices: mismatch negativity and P300
Timepoint [1] 286824 0
time point: at baseline and after training as well as 3 month after intervention commencement
Secondary outcome [1] 296736 0
nil
Timepoint [1] 296736 0
nil

Eligibility
Key inclusion criteria
Inclusion criteria included score 23 and above on Mini Mental State Examination. The participants were required to able to use computer and agreed to come to session for 2-3 hour a day.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The participants will be excluded if they are found to be suffering from neurological impairment ( such as stroke, Parkinson disorder etc), mental illness or suspected mild cognitive impairment i.e hearing threshold less than 20dB. They will also be excluded if they have IQ less than 75.

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)
The participants will be randomly assigned to two groups, an immediate treatment group and waitlist control group. The participants were recruited via Hunter Medical Research Institution and flyers were displayed in strategic places. Cumulative samplings were used in two stages whereby 100 information sheets were sent to volunteer homes for participation in the research. Allocation was concealed by a number containers. All participants were screened for their eligibility and assessed with various assessments including baseline assessment before been randomised to either treatment group or waitlist group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomised numbers were generated from randomised software that available in website. Paper toss was performed by two researcher that blind to procedure of the research and to randomly according to number that generated by the software to assign the participant to either immediate group or waitlist group. Researchers who involved in testing with neuropsychological assessment and EEG recording were single blinded during these procedures

The website links : http://www.randomizer.org/form.htm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 284983 0
University
Name [1] 284983 0
University of Newcastle DVCR-R grant
Address [1] 284983 0
The University of Newcastle
University Drive
Callaghan NSW 2308 Australia
Country [1] 284983 0
Australia
Primary sponsor type
University
Name
University of Newcastle DVCR-R grant
Address
The University of Newcastle
University Drive
Callaghan NSW 2308 Australia
Country
Australia
Secondary sponsor category [1] 283847 0
None
Name [1] 283847 0
Address [1] 283847 0
Country [1] 283847 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this project to investigate the effects of computerized cognitive rehabilitation on healthy elderly. This project is initiate and replicate from schizophrenia project which having problem in recruiting the participant. The project looks at the importance of electrophysiological measures as indices of cognitive decline and rehabilitation in healthy elderly
Trial website
Nil
Trial related presentations / publications
Poster Presentation at Postgraduate Conference University of Newcastle (30.11.2011)
Public notes

Contacts
Principal investigator
Name 33985 0
Address 33985 0
Country 33985 0
Phone 33985 0
Fax 33985 0
Email 33985 0
Contact person for public queries
Name 17232 0
shalisah Sharip
Address 17232 0
School of Psychology
Behavioural Sciences Building - W210
The University of Newcastle
University Drive
Callaghan NSW 2308 Australia
Country 17232 0
Australia
Phone 17232 0
+60413745877
Fax 17232 0
+61 2 4921 6980
Email 17232 0
c3097874@uon.edu.au
Contact person for scientific queries
Name 8160 0
Professor Patricia Michie
Address 8160 0
School of Psychology
Behavioural Sciences Building - W210
The University of Newcastle
University Drive
Callaghan NSW 2308 Australia
Country 8160 0
Australia
Phone 8160 0
+61 2 4921 5761
Fax 8160 0
+61 2 4921 6980
Email 8160 0
Pat.Michie@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary