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Trial registered on ANZCTR


Registration number
ACTRN12619001634167
Ethics application status
Approved
Date submitted
29/10/2019
Date registered
25/11/2019
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Lifestyle Intervention Study to Reduce Modifiable Risk Factors for Dementia in People with Mild Cognitive Impairment - The COAST Study
Scientific title
A Feasibility Randomised Controlled Trial of a Targeted Risk-Reduction Program for People with Mild Cognitive Impairment
Secondary ID [1] 299668 0
Nil known
Universal Trial Number (UTN)
U1111-1242-7168
Trial acronym
COAST Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 315007 0
Condition category
Condition code
Neurological 313345 313345 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The COAST study will use three intervention groups, each designed to reduce modifiable risk factors for dementia. The three interventions will vary in intervention intensity level, with Group 1 being low intensity, Group 2 being moderate intensity, and Group 3 being high intensity. All participants will set SMART goals for dementia risk reduction behaviour change with an experienced psychologist at the Healthy Brain Ageing (HBA) clinic located at the Sunshine Coast Mind and Neuroscience - Thompson Institute (SCMN-TI) prior to group randomisation.

Group 1 - Low intensity (n=30):
A dementia risk information only active control group consisting of a comprehensive feedback report of participant's dementia risk profile as determined by comprehensive assessments conducted by experienced medical practitioner, neuropsychologist, and psychologist at the HBA clinic to participants' referring doctor. This report will be written by the HBA clinical psychologist or clinical neuropsychologist, as per standard clinical practice. In addition, individuals will be offered a 45-min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies.

Group 2 - Medium intensity (n=30):
A comprehensive feedback report outlining dementia risk will be given to the participant and GP, and participants will also be offered a 45-min appointment with a research psychologist to discuss dementia risk factors and possible risk reduction strategies (as per Group 1). In addition, participants will receive 10 weeks of text message alerts (sent weekly) regarding healthy brain ageing strategies and recommendations in order to assist participants to achieve their personalised behavior-change goals (n=30). Text messages will be personalised to each participants' goals as identified in the SMART goal setting interview conducted with the psychologist. Text message content will be selected from a pre-set menu of messages related to different dementia risk factors, with 10 messages in each category. Categories include: Physical Activity; Nutrition; Obesity and vascular risk factors; Cognitive stimulation; Depression/Anxiety; Sleep; and Smoking.

Group 3 - High intensity (n=30):
A comprehensive feedback report outlining dementia risk will be given to the participant and GP, and participants will be offered a 45-min appointment with a psychologist to discuss dementia risk factors and possible risk reduction strategies (as per Groups 1 and 2). In addition, participants will attend 10 weekly sessions with a psychologist. Participants allocated to Group 3 will attend the HBA clinic once weekly at a mutually agreed time to meet with a trained psychologist for one hour. Based on the results of their comprehensive assessment, individualised treatment plans will be developed via team consensus. The psychologist will initially introduce and discuss this proposed treatment plan with the participant, especially with reference to their previously set goals. The 10-week program will then be tailored and delivered by a clinical psychologist to target the most significant and relevant modifiable health and lifestyle risk factors for dementia. Potential targets for intervention include depression, cardiovascular disease, smoking, exercise, and diet as well as specific cognitive difficulties (e.g. memory or attention problems). Techniques to be utilised in each participant’s program will therefore vary based on the individualised plan, but in all cases will comprise a combination of motivational interviewing, structured problem-solving, psycho-education using both internally developed materials from the Sydney-based investigators as well as external materials such as from Dementia Australia, the Heart Foundation, Beyond Blue or the Australian Government (dietary or alcohol guidelines), and cognitive strategy training.

Since this is a feasibility trial, adherence and uptake will be assessed by the HBA Program Co-ordinator according to the following criteria:
1. Feasibility of recruitment:
• % of eligible people agreeing to participate in the trial. Feasibility will be defined by a 50% uptake in trial participation.
2. Feasibility of acceptability:
• % of trial completers. Acceptability will be defined by 60% completion rate.
Stop-Go criteria:
At 6-months, feasibility and acceptability will be reviewed and if the above criteria are not met, the trial will be modified (with appropriate ethical and clinical governance approval).

Intervention code [1] 315931 0
Prevention
Intervention code [2] 315932 0
Lifestyle
Intervention code [3] 315933 0
Behaviour
Comparator / control treatment
Group 1 described above will be an active control condition, consisting of a dementia risk profile report delivered to participants GP. This group will model existing treatment/management strategies, which primarily consist of information provision to people regarding dementia risk factors in the hope of inducing behaviour change.
Control group
Active

Outcomes
Primary outcome [1] 321823 0
Feasibility of recruitment.

• % of eligible people agreeing to participate in the trial.

Feasibility will be defined by a 50% uptake in trial participation.
Timepoint [1] 321823 0
At 6-months, feasibility will be reviewed and if the above criteria are not met, the trial will be modified
Primary outcome [2] 321824 0
Feasibility of acceptability:

• % of trial completers.

Acceptability will be defined by 60% completion rate.
Intervention completion for Group 3 is defined as attendance of at least 75% of prescribed intervention sessions and attendance at post-intervention follow-up assessment.
Timepoint [2] 321824 0
At 6-months, acceptability will be reviewed and if the above criteria are not met, the trial will be modified
Secondary outcome [1] 376358 0
HBA Dementia Risk Profile Report
Timepoint [1] 376358 0
Post 10-week intervention
Secondary outcome [2] 376359 0
Change in sleep duration as determined by actigraphy monitoring and 7-day sleep diary completion
Timepoint [2] 376359 0
Post 10-week intervention
Secondary outcome [3] 376360 0
Change in visual attention and task switching assessed using the Trail making test.
Timepoint [3] 376360 0
Post 10-week intervention
Secondary outcome [4] 376362 0
Change in global cognitive function assessed by Montreal Cognitive Assessment (MoCA).

Timepoint [4] 376362 0
Post 10-week intervention
Secondary outcome [5] 376364 0
Change in symptoms of depression assessed by Geriatric Depression Scale (GDS-15).

Timepoint [5] 376364 0
Post 10-week intervention
Secondary outcome [6] 376366 0
Change in regional brain volumes as assessed by structural MRI scan
Timepoint [6] 376366 0
Post 10-week intervention
Secondary outcome [7] 376367 0
Changed resting state functional network activation as assessed by resting state functional MRI scan
Timepoint [7] 376367 0
Post 10-week intervention
Secondary outcome [8] 376368 0
Attainment of SMART goal for dementia risk reduction behaviour change as determined in goal-setting interview with HBA psychologist
Timepoint [8] 376368 0
Post 10-week intervention
Secondary outcome [9] 377057 0
Change in sleep quality as determined by actigraphy monitoring and 7-day sleep diary completion
Timepoint [9] 377057 0
Post 10-week intervention
Secondary outcome [10] 377058 0
Change in sleep onset latency defined by actigraphy and 7-day sleep diary
Timepoint [10] 377058 0
Post 10-week intervention
Secondary outcome [11] 377059 0
Change in working memory capacity assessed by Digit Span subtest (Wechsler Adult Intelligence Scale, IV)
Timepoint [11] 377059 0
Post 10-week intervention
Secondary outcome [12] 377060 0
Change in memory assessed by WMS-IV Logical Memory I and II (Wechsler Memory Scale, IV).
Timepoint [12] 377060 0
Post 10-week intervention
Secondary outcome [13] 377061 0
Change in visuospatial memory assessed by Rey Complex Figure Test
Timepoint [13] 377061 0
Post 10-week intervention
Secondary outcome [14] 377062 0
Change in verbal fluency assessed by Controlled Oral Word Association Test
Timepoint [14] 377062 0
Post 10-week intervention
Secondary outcome [15] 377063 0
Change in auditory-verbal memory assessed by Rey Auditory Verbal Learning Test
Timepoint [15] 377063 0
Post 10-week intervention
Secondary outcome [16] 377064 0
Change in inhibitory control performance assessed by D-KEFS Colour –Word Interference Test.
Timepoint [16] 377064 0
Post 10-week intervention
Secondary outcome [17] 377065 0
Change in word retrieval assessed by Boston Naming Test.
Timepoint [17] 377065 0
Post 10-week intervention
Secondary outcome [18] 377066 0
Change in perceived cognitive difficulties assessed by British Columbia Cognitive Complaints Inventory (BC-CCI).
Timepoint [18] 377066 0
Post 10-week intervention
Secondary outcome [19] 377067 0
Change in depressive symptoms assessed by Structured Interview Guide for the Hamilton Depression Rating Scale (SIGH-D).
Timepoint [19] 377067 0
Post 10-week intervention
Secondary outcome [20] 377068 0
Change in symptoms of anxiety assessed by State/Trait Anxiety Inventory.
Timepoint [20] 377068 0
Post 10-week intervention
Secondary outcome [21] 377069 0
Change in subjective memory failures assessed by Everyday Memory Questionnaire (EMQ).
Timepoint [21] 377069 0
Post 10-week intervention
Secondary outcome [22] 377070 0
Change in symptoms of anxiety assessed by Geriatric Anxiety Inventory (GAI).
Timepoint [22] 377070 0
Post 10-week intervention
Secondary outcome [23] 377071 0
Change in sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI).
Timepoint [23] 377071 0
Post 10-week intervention
Secondary outcome [24] 377072 0
Change in subjective well-being assessed by WHO-5 Well-being Index.
Timepoint [24] 377072 0
Post 10-week intervention.
Secondary outcome [25] 377073 0
Change in level of social support assessed by Duke Social Support Index.
Timepoint [25] 377073 0
Post 10-week intervention
Secondary outcome [26] 377074 0
Change in alcohol consumption assessed by AUDIT-C.
Timepoint [26] 377074 0
Post 10-week intervention
Secondary outcome [27] 377075 0
Change in time spent engaging in cognitively stimulating activities assessed by Cognitively-stimulating activities – revised.
Timepoint [27] 377075 0
Post 10-week intervention
Secondary outcome [28] 377076 0
Change in memory strategy usage assessed by Multifactorial Memory Questionnaire.
Timepoint [28] 377076 0
Post 10-week intervention

Eligibility
Key inclusion criteria
1. Individuals aged 60-75 years who meet the Winblad criteria for mild cognitive impairment (MCI) as tested at the HBA clinic;
2. Able to engage in the study over a period of three months including attendance at the Thompson Institute on a weekly basis over a 12-week period.
3. Willingness to undergo cognitive testing, actigraphy, complete self-report questionnaires, and an MRI scan (pass MRI safety checklist) at baseline and post-intervention.
4. Access to and ability to use mobile phone for text message alerts.
Minimum age
60 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with any of the following will be excluded from participation:
1. Prior head injury with loss of consciousness >30 minutes
2. Stroke or TIA with any residual cognitive, physical, or functional impairment.
3. Heart disease, Atherosclerosis, or any other heart/vascular condition
4. History of schizophrenia or non-affective psychiatric disorder (eg: ADHD, CFS, PTSD).
5. Acute psychosis.
6. Major neurological condition, such as Parkinson’s disease, epilepsy etc.
7. Current or past alcohol or other substance misuse.
8. Intellectual disability.
9. Insufficient English language skills to complete standardised assessment.
10. Involved in another clinical trial.

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)
Randomisation will be completed by an independent researcher with expertise in clinical trial management who will have no direct contact with participants. Participants will receive the randomisation outcome letter in a sealed envelope following their baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using random computer software allocation to intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Since this is a feasibility trial, there will be three primary outcomes:
1. Feasibility of recruitment:
• % of eligible people agreeing to participate in the trial. Feasibility will be defined by a 50% uptake in trial participation.
2. Feasibility of acceptability:
• % of trial completers. Acceptability will be defined by 60% completion rate.
3. The effect size of behaviour-change as measured by goal attainment across the three treatment arms.

Secondary outcomes will assessed using mixed design ANOVA.

Recruitment
Recruitment status
Not yet recruiting
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)
QLD

Funding & Sponsors
Funding source category [1] 304144 0
Charities/Societies/Foundations
Name [1] 304144 0
Heller Foundation Pty Ltd
Address [1] 304144 0
2 First Avenue, Caloundra, QLD. 4551.
Country [1] 304144 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast
Address
Sunshine Coast Mind and Neuroscience - Thompson Institute
12 Innovation Parkway,
Birtinya, 4575. QLD.
Country
Australia
Secondary sponsor category [1] 304374 0
Individual
Name [1] 304374 0
Dr Ben Isbel
Address [1] 304374 0
Sunshine Coast Mind and Neuroscience - Thompson Institute
12 Innovation Parkway,
Birtinya, 4575. QLD.
Country [1] 304374 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304624 0
University of the Sunshine Coast Human Research Ethics Committee (USC HREC)
Ethics committee address [1] 304624 0
Human Research Ethics Committee
University of the Sunshine Coast
Locked Bag 4
MAROOCHYDORE DC QLD 4558
AUSTRALIA
Ethics committee country [1] 304624 0
Australia
Date submitted for ethics approval [1] 304624 0
01/07/2019
Approval date [1] 304624 0
30/07/2019
Ethics approval number [1] 304624 0
A191279

Summary
Brief summary
The COAST Study will assess the feasibility and efficacy of lifestyle intervention programs to reduce modifiable risk factors for dementia through behaviour-change in people with Mild Cognitive Impairment (MCI). The study will use three different interventions of varying intensity level - 1) delivery of risk information to change behaviour; 2) delivery of risk information plus weekly text message support to change behaviour; 3) delivery of risk information plus weekly face-to-face intervention delivered by a psychologist designed to change behaviour. Acceptability of the interventions will be assessed along with cognitive and affective outcomes. It is hypothesised that the text message support group will display greater behaviour-change than the information only group, and that the face-to-face group will show the greatest change of all three groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97630 0
Dr Ben Isbel
Address 97630 0
Sunshine Coast Mind and Neuroscience - Thompson Institute
12 Innovation Parkway,
Birtinya, 4575. QLD.
Country 97630 0
Australia
Phone 97630 0
+61 7 5456 3935
Fax 97630 0
Email 97630 0
bisbel@usc.edu.au
Contact person for public queries
Name 97631 0
Dr Ben Isbel
Address 97631 0
Sunshine Coast Mind and Neuroscience - Thompson Institute
12 Innovation Parkway,
Birtinya, 4575. QLD.
Country 97631 0
Australia
Phone 97631 0
+61 7 5456 3935
Fax 97631 0
Email 97631 0
bisbel@usc.edu.au
Contact person for scientific queries
Name 97632 0
Dr Ben Isbel
Address 97632 0
Sunshine Coast Mind and Neuroscience - Thompson Institute
12 Innovation Parkway,
Birtinya, 4575. QLD.
Country 97632 0
Australia
Phone 97632 0
+61 7 5456 3935
Fax 97632 0
Email 97632 0
bisbel@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD sharing has been approved under the ethics approval for this study.
What supporting documents are/will be available?
No other documents available
Summary results
No Results