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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild Cognitive Impairment

Condition category

Condition code

Neurological

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]

Prevention

Intervention code [2]

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]

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]

Assessments, for both groups, will be undertaken at pre-intervention (baseline), post-intervention, and at 6-month follow-up.

Secondary outcome [1]

Psychological well-being: self-report and family report

Timepoint [1]

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]

Government body

Name [1]

NHMRC

Address [1]

GPO Box 1421
Canberra
ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Plenty Road, Melbourne, Victoria 3086

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Caulfield General Medical Centre

Address [1]

240 Kooyong Road, Caulfield, Melbourne, Victoria

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Ethics Committee

Ethics committee address [1]

The Alfred, Bayside Health
Commercial Road
Melbourne Victoria 3004

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/03/2008

Approval date [1]

29/04/2008

Ethics approval number [1]

88/08

Summary

Brief summary

The objective of the study was to evaluate the effectiveness of memory groups in improving memory strategies and memory ability of older people, including those with amnestic mild cognitive impairment (aMCI). The LaTCH memory group program is a 2-hour-by-6-week cognitive-behavioral intervention providing knowledge about memory as well as skills in memory strategies and their application in daily activities, We expected that older people participating in the program would be able to improve memory ability in daily activities through strategy use and improved confidence, rather than improving memory impairment as measured by standard memory tests.

Trial website

Trial related presentations / publications

Kinsella, GJ., Ames, D., Storey, E., Ong, B., Pike, KE., Saling, MM., Mullaly, E., & Rand, E. (2015, in press). Strategies for Improving Memory: a Randomized Trial of Memory Groups for Older People, including those with Mild Cognitive Impairment. Journal of Alzheimer’s Disease (accepted 28/7/15)

Public notes

Contacts

Principal investigator

Name

Prof Glynda Kinsella

Address

La Trobe University
School of Psychology & Public Health
Melbourne
Victoria 3086

Country

Australia

Phone

+61 3 9479 2409

Fax

+61 3 9479 1956

[email protected]

Contact person for public queries

Name

Glynda Kinsella

Address

La Trobe University
School of Psychology & Public Health
Melbourne
Victoria 3086

Country

Australia

Phone

+61 3 94792409

Fax

+61 3 94791956

[email protected]

Contact person for scientific queries

Name

Glynda Kinsella

Address

La Trobe University
School of Psychology & Public Health
Melbourne
Victoria 3086

Country

Australia

Phone

+61 3 94792409

Fax

+61 3 94791956

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

To preserve participant anonymity, individual participant data will not be made publicly available

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email
7137	Study protocol	Kinsella, 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.
7138	Statistical analysis plan	Kinsella, 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.
7139	Informed consent form		[email protected]
7140	Clinical study report	Kinsella, 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.
7141	Ethical approval	Kinsella, 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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

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