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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01998711




Registration number
NCT01998711
Ethics application status
Date submitted
12/09/2005
Date registered
2/12/2013
Date last updated
2/12/2013

Titles & IDs
Public title
Impact of a Memory Group for Older Adults Reporting Memory Difficulties
Scientific title
Memory Group Intervention for Mild Cognitive Impairment: Impact of a Memory Group for Older Adults Reporting Memory Difficulties.
Secondary ID [1] 0 0
156/04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Memory group

Experimental: Memory group - Memory training

No Intervention: Control - Standard care


Behaviour: Memory group
Five 1-1.5 hour weekly session of memory training
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Neuropsychological measures of memory and attention
Timepoint [1] 0 0
Primary outcome [2] 0 0
Self-report on memory performance in everyday activities
Timepoint [2] 0 0
Primary outcome [3] 0 0
Self-report on use of memory strategies
Timepoint [3] 0 0
Primary outcome [4] 0 0
Informant report on memory performance in everyday activities
Timepoint [4] 0 0
Primary outcome [5] 0 0
Informant report on use of strategies
Timepoint [5] 0 0
Primary outcome [6] 0 0
Assessment of psychological wellbeing
Timepoint [6] 0 0

Eligibility
Key inclusion criteria
Participant presents with memory complaint Objective memory impairment on
neuropsychological tests Normal general cognitive function Adequate activities of daily
living Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines
Living in the community Absence of significant visual or auditory impairment English
speaker -
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Caulfield General Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3079 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Aims:

To evaluate the efficacy of a brief intensive intervention for persons with mild cognitive
impairment, assisted by family members or friends. To equip persons with mild cognitive
impairment with specific skills to prevent memory failures and improve the capacity of
patients and families to cope with everyday memory difficulties.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01998711
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Glynda J Kinsella, PhD
Address 0 0
Caulfield General Medical Centre - Psychology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01998711