Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000711617
Ethics application status
Approved
Date submitted
17/10/2005
Date registered
4/11/2005
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Early Intervention for amnestic Mild Cognitive Impairment: A Randomised Trial of Memory Management
Scientific title
Evaluation of a memory group intervention for mild cognitive impairment to improve everyday memory performance, use of strategies and psychological well-being of the person with mild cognitive impairment and the family.
Secondary ID [1] 300669 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 861 0
Condition category
Condition code
Neurological 928 928 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will investigate the efficacy of a memory group intervention for older people with memory difficulties (mild cognitive impairment) as well as older people who wish to improve their memory ability. The intervention will include family members or close friends and will focus on the management of everyday memory difficulties by developing increased awareness of changes in everyday memory that can occur as a result of health or aging and increasing knowledge of memory strategies that can be used to prevent everyday memory failures. A randomised pre-test, post-test, 6-month follow-up will be used to evaluate the impact of the 6-week memory group intervention (one 2hr session per week). Over successive cohorts, families will be randomly assigned to an early-ntervention group or a late-intervention control group.
Intervention code [1] 722 0
Prevention
Intervention code [2] 316998 0
Treatment: Other
Comparator / control treatment
Participants are randomsied into early- and late-intervention groups and compared at post-test and follow-up assessments. the late-intervention group will provide a control for intervention effects across assessment phases.
Control group
Active

Outcomes
Primary outcome [1] 1216 0
To evaluate the efficacy of the intervention, outcome wil be assessed by performance on neuropsychological tests of memory impairment and disability in everyday memory; self-report of everyday memory ability; knowledge and self-report of use of memory strategies in everyday life by the participant and family participant.
Timepoint [1] 1216 0
Assessments, for both groups, will be undertaken at pre-intervention (baseline), post-intervention, and at 6-month follow-up.
Secondary outcome [1] 2212 0
Psychological well-being: self-report and family report
Timepoint [1] 2212 0
Undertaken at pre-intervention (baseline), post-intervention, and at 6-month follow-up and these will be used to predict individual response to intervention.

Eligibility
Key inclusion criteria
The sample will consist of families who have a family member reporting memory complaint and recently assessed within a Cognitive, Dementia & Memory Service (CDAMS or memory clinic) and also healthy older adult volunteers recruited from the local community via advertising. Patients are referred to the Cognitive Dementia & Memory Service for an evaluation of suspected dementia and will be assigned to the potential pool of participants if they receive a diagnosis of mild cognitive impairment after a comprehensive clinical assessment. MCI can describe a range of presentations with mild neuropsychological difficulties, but for this study the focus will be on amnestic MCI.Inclusion/exclusion criteria: (i) Participant presents with memory complaint; (ii)Objective memory impairment on neuropsychological tests; (iii) Normal general cognitive function; (iv) Adequate activities of daily living; (v) Fails to reach criterion for clinical dementia according to NINCDS-ADRDA guidelines.Additional selection criteria: (i) English speaker; (ii) Living in the community.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of dementia; co-morbid medical conditions associated with functional decline or impact on cognition; untreated major depression and any other severe psychiatric disorder and /or behavioural problems; significant impairment of vision or hearing or communication that would interfere with study participation; availability during the study period.

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)
Sealed envelopes containing group allocation are opened once the participant has been recruited into the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are randomly allocated to either early-intervention or late-inetervention groups based on their order of entry into the research program. Random numbers are generated by SPSS v12 using a uniform distribution (i.e., RV.UNIFORM function) with the restriction that, within every block, equal numbers allocated to each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
27/08/2008
Date of last participant enrolment
Anticipated
Actual
23/03/2011
Date of last data collection
Anticipated
Actual
20/02/2012
Sample size
Target
300
Accrual to date
Final
219
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1022 0
Government body
Name [1] 1022 0
NHMRC
Country [1] 1022 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road, Melbourne, Victoria 3086
Country
Australia
Secondary sponsor category [1] 887 0
Hospital
Name [1] 887 0
Caulfield General Medical Centre
Address [1] 887 0
240 Kooyong Road, Caulfield, Melbourne, Victoria
Country [1] 887 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305485 0
The Alfred Ethics Committee
Ethics committee address [1] 305485 0
Ethics committee country [1] 305485 0
Australia
Date submitted for ethics approval [1] 305485 0
25/03/2008
Approval date [1] 305485 0
29/04/2008
Ethics approval number [1] 305485 0
88/08

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

Contacts
Principal investigator
Name 35371 0
Prof Glynda Kinsella
Address 35371 0
La Trobe University School of Psychology & Public Health Melbourne Victoria 3086
Country 35371 0
Australia
Phone 35371 0
+61 3 9479 2409
Fax 35371 0
+61 3 9479 1956
Email 35371 0
[email protected]
Contact person for public queries
Name 9911 0
Glynda Kinsella
Address 9911 0
La Trobe University School of Psychology & Public Health Melbourne Victoria 3086
Country 9911 0
Australia
Phone 9911 0
+61 3 94792409
Fax 9911 0
+61 3 94791956
Email 9911 0
[email protected]
Contact person for scientific queries
Name 839 0
Glynda Kinsella
Address 839 0
La Trobe University School of Psychology & Public Health Melbourne Victoria 3086
Country 839 0
Australia
Phone 839 0
+61 3 94792409
Fax 839 0
+61 3 94791956
Email 839 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: To preserve participant anonymity, individual participant data will not be made publicly available



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolKinsella, G.J., Ames, D., Storey, E., Ong, B., Pike, K.E., Saling, M., Clare, L., Mullaly, E., & Rand, E. (2016). Strategies for improving memory: A randomized trial of memory groups for older people, including those with mild cognitive impairment. Journal of Alzheimer's Disease, 49,1, 31-43. DOI: 10.3233/JAD-150378.  
Statistical analysis planKinsella, G.J., Ames, D., Storey, E., Ong, B., Pike, K.E., Saling, M., Clare, L., Mullaly, E., & Rand, E. (2016). Strategies for improving memory: A randomized trial of memory groups for older people, including those with mild cognitive impairment. Journal of Alzheimer's Disease, 49,1, 31-43. DOI: 10.3233/JAD-150378.  
Informed consent form  [email protected]
Clinical study reportKinsella, G.J., Ames, D., Storey, E., Ong, B., Pike, K.E., Saling, M., Clare, L., Mullaly, E., & Rand, E. (2016). Strategies for improving memory: A randomized trial of memory groups for older people, including those with mild cognitive impairment. Journal of Alzheimer's Disease, 49,1, 31-43. DOI: 10.3233/JAD-150378.  
Ethical approvalKinsella, G.J., Ames, D., Storey, E., Ong, B., Pike, K.E., Saling, M., Clare, L., Mullaly, E., & Rand, E. (2016). Strategies for improving memory: A randomized trial of memory groups for older people, including those with mild cognitive impairment. Journal of Alzheimer's Disease, 49,1, 31-43. DOI: 10.3233/JAD-150378. [email protected]


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Kinsella, G.J., Ames, D., Storey, E., Ong, B., Pik... [More Details] Journal results publication.pdf

Documents added automatically
No additional documents have been identified.