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Trial registered on ANZCTR


Registration number
ACTRN12612001149853
Ethics application status
Approved
Date submitted
29/10/2012
Date registered
31/10/2012
Date last updated
7/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of MAXCOG (MAXimising COGnition in Preclinical and Early Dementia): an individualised early intervention program for people with Mild Cognitive Impairment or early dementia and their family supporters
Scientific title
A randomised controlled trial of MAXCOG (MAXimising COGnition in Preclinical and Early Dementia: an individualised early intervention program for people with Mild Cognitive Impairment or early dementia and their family supporters) versus Usual Care to assess the efficacy of MAXCOG to improve occupational performance problems relating to self-care, productivity, and leisure (measured by the Canadian Occupational Performance Measure (COPM)
Secondary ID [1] 281458 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
MAXCOG RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 287721 0
Early Dementia 287722 0
Condition category
Condition code
Neurological 288057 288057 0 0
Dementias
Mental Health 288070 288070 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This semi-tailored intervention is designed to deliver psycho-education and counselling to clients with MCI or early dementia and their primary caregivers in the weeks following diagnosis. The objective of the intervention is to teach a range of new strategies to help manage cognitive impairment in daily life.
The content will be based on a set of information handouts recently developed by our project team at La Trobe University and Kingston Centre (www.latrobe.edu.au/aipca/projects/mci). An adapted problem solving approach will be adopted in which clients and caregivers will be encouraged to participate in the process of developing the goals for the therapy, and finding the most appropriate strategies to manage cognitive impairment in their day-to-day lives.
Session will be face-to-face with the client and their primary caregiver, administered by an Alzheimer's Australia counsellor;
Duration/frequency of the intervention: 1 hour session administered weekly for 4 weeks.
Intervention code [1] 285961 0
Treatment: Other
Intervention code [2] 285974 0
Behaviour
Comparator / control treatment
Usual care consists of careful assessment and provision of a diagnosis. At the Cognitive, Dementia and Memory Service (CDAMS) final feedback session efforts are made to provide recommendations and written materials to support clients and their family supporters to manage cognitive difficulties and to link them into community-based services.
Control group
Active

Outcomes
Primary outcome [1] 288263 0
Canadian Occupational Performance Measure (COPM)[Detection of occupational performance problems relating to self-care, productivity, and leisure]. CLIENT & CAREGIVER.
Timepoint [1] 288263 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [1] 299719 0
Illness Cognition Questionnaire [Adjustment to the experience of chronic illness]. CLIENT.
Timepoint [1] 299719 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [2] 299720 0
Knowledge of cognitive strategies adaptation of Troyer (2001) [Knowledge of strategies]. CLIENT & CAREGIVER.
Timepoint [2] 299720 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [3] 299721 0
Multifactorial Metacognition Questionnaire an adaptation of Troyer and Rich (2002) [Use of cognitive strategies described on the handouts given to clients]. CLIENT & CAREGIVER.
Timepoint [3] 299721 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [4] 299722 0
Health-related quality of life for people with dementia: DEMQoL [HRQoL in dementia (emotion, memory and quality of life)]. CLIENT.
Timepoint [4] 299722 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [5] 299723 0
Zarit Carer Burden Scale Short Version [Carer-reported burden]. CAREGIVER.
Timepoint [5] 299723 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [6] 299724 0
DEMQoL-Proxy [HRQoL in dementia (emotion, memory and quality of life) - proxy-rated]. CAREGIVER.
Timepoint [6] 299724 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [7] 299725 0
Revised Memory and Behaviour Checklist [Caregivers' ratings of the clients' cognitive and behavioural difficulties and the impact]. CAREGIVER.
Timepoint [7] 299725 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [8] 299726 0
Depression Anxiety Stress Scales (DASS) [Depression, anxiety and stress (caregiver)]. CAREGIVER.
Timepoint [8] 299726 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [9] 299727 0
Geriatric Depression Scale [Depression]. CLIENT.
Timepoint [9] 299727 0
6 weeks post-baseline (=2 weeks post-intervention)
Secondary outcome [10] 299728 0
Open questions and ratings about their experience of the counselling and knowledge of the strategies and use of community services during the counselling period. CLIENT & CAREGIVER.
Timepoint [10] 299728 0
6 weeks post-baseline (=2 weeks post-intervention)

Eligibility
Key inclusion criteria
Community-dwelling clients with a recent (i.e., less than or equal to 6 months) clinical diagnosis of MCI or early dementia (any type); fluent in English; age greater than or equal to 50 years; Mini–mental state examination (MMSE) score greater than or equal to 20; and a primary caregiver with close contact to the client willing to participate in the study and the intervention.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clients with severe somatic or psychiatric comorbidity, or impaired hearing or vision (which would impair their ability to complete the intervention). Clients already involved in other counselling or cognitive rehabilitation programs.

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)
Consecutive clients and primary caregivers eligible for the study will be approached at their CDAMS feedback session (i.e., the final session provided by the clinic in which a diagnosis is provided as well as assistance with ongoing management and links to community-based services). If interested, CDAMS key workers will provide information about the study and obtain written informed consent from the client and primary caregiver. One to two weeks after the feedback session, baseline data will be collected (in person) by a MONARC researcher. Following baseline data collection, participants will be randomly allocated to the MAXCOG intervention or usual care by a person not involved in data collection (the MONARC researcher responsible for data collection will be blind to group allocation). The MONARC researcher will collect follow up data two weeks post-intervention (via telephone). (Ideally we would also undertake longer-term follow up; we will seek additional funding for further follow up data collection). Losses to follow up will be minimised and data quality maximised by collecting follow up data via telephone (rather than mail). Attrition will be monitored and reasons for withdrawal will be recorded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a central allocation process to randomize participants, using a computer programme and a random block size algorithm to prevent imbalance between the allocation groups - stratified by MMSE score (20–23; 24–30), diagnosis (MCI; early dementia), and use/non-use of anti-dementia drugs.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2013
Actual
16/10/2013
Date of last participant enrolment
Anticipated
Actual
24/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 5903 0
3192
Recruitment postcode(s) [2] 5904 0
3930
Recruitment postcode(s) [3] 5905 0
3162

Funding & Sponsors
Funding source category [1] 286228 0
Charities/Societies/Foundations
Name [1] 286228 0
Alzheimer's Australia - Victoria (Alzheimer's Australia Dementia Research Foundation)
Country [1] 286228 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Victoria 3800
Country
Australia
Secondary sponsor category [1] 285037 0
None
Name [1] 285037 0
Address [1] 285037 0
Country [1] 285037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288296 0
Southern Health HREC A
Ethics committee address [1] 288296 0
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 288296 0
Australia
Date submitted for ethics approval [1] 288296 0
21/11/2012
Approval date [1] 288296 0
13/02/2013
Ethics approval number [1] 288296 0

Summary
Brief summary
Currently few services aim to support people in the community who are
experiencing mild cognitive difficulties or who have early dementia. However,
the experience of cognitive difficulties and worry about the future can be very
stressful for the person and their close family members; and may make
everyday tasks, such as interacting in a group or managing finances, much
more difficult. In this project we will develop and evaluate a new face-to-face
psycho-educational and counselling program for people with cognitive
difficulties and their close family members. The aim of the intervention is to
help people implement practical strategies to manage cognitive difficulties in
their day-to-day life. By increasing strategy use, we also hope to reduce the
anxiety and depression that people with mild cognitive difficulties and their
family members can experience. We will evaluate our counselling program by
comparing the outcomes for people who undergo the program with those of a
comparison group who receive service as usual (a randomised controlled
trial).
Trial website
Trial related presentations / publications
Ryburn B, Varanelli L, Wells Y. How Helpful are our handouts? An evaluation of information handouts for clients with MCI and their family members. International Neuropsychological Society Mid Year Meeting / ASSBI 4th Pacific Rim Conference. J Int Neuropsych Soc 2011;17(S2):46 [Abstract].
Public notes

Contacts
Principal investigator
Name 34888 0
Dr Bridget Regan
Address 34888 0
c/o Medical Admin, Kingston Centre, Warrigal Road, Cheltenham, Vic 3192
Country 34888 0
Australia
Phone 34888 0
+61 3 9265 1268
Fax 34888 0
Email 34888 0
[email protected]
Contact person for public queries
Name 18135 0
Dr Bridget Regan
Address 18135 0
c/- Medical Admin
Kingston Centre
Warrigal Rd
Cheltenham Vic 3192
Country 18135 0
Australia
Phone 18135 0
+61 3 9265 1268
Fax 18135 0
Email 18135 0
[email protected]
Contact person for scientific queries
Name 9063 0
Dr Bridget Regan
Address 9063 0
c/- Medical Admin
Kingston Centre
Warrigal Rd
Cheltenham Vic 3192
Country 9063 0
Australia
Phone 9063 0
+61 3 9265 1268
Fax 9063 0
Email 9063 0
[email protected]

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No Supporting Document Provided



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