Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000195156
Ethics application status
Approved
Date submitted
4/02/2019
Date registered
12/02/2019
Date last updated
18/02/2020
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Club Connect: a healthy brain ageing cognitive training program for older adults
Scientific title
Club Connect: a feasibility RCT of a healthy brain ageing cognitive training program for older adults
Secondary ID [1] 297288 0
None
Universal Trial Number (UTN)
U1111-1227-9458
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 311367 0
Condition category
Condition code
Mental Health 310005 310005 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will comprise a Healthy Brain Ageing cognitive training (CT) program which will run for 10 consecutive weeks on level 4 of the O’Brien Centre at St Vincent’s Hospital. The Healthy Brain Ageing intervention will comprise face-to-face, two-hour weekly group CT sessions including: i) 50 minutes of psychoeducation; and ii) 50 minutes of computer-based CT; in between participants will have a 20 minute tea-break, where they will have the opportunity to socially engage with each other.

i. Psychoeducation: this component will include education on the following topics: the brain, attention and processing speed, learning and memory, executive function, vascular risk factors, diet and exercise, depression and anxiety, and sleep, and participants will be given a copy of all slides in the 'Club Connect Workbook'. All material will be provided by specialist clinicians (e.g., Psychiatrists, Neuropsychologists, Psychologists, Occupational Therapists etc.). This component may have a maximum of 14 participants per group.
ii. CT: The CT intervention will be delivered by Clinical Neuropsychologists and Psychologists, and will utilize Medalia’s Neuropsychological Education Approach to Remediation. CT will include widely available educational computer software (e.g. Penny Adams Brain Trainer, Magic Academy, Thinkin’ Things Collection 3, Ice Cream Mania, Pet Shop Hop etc.) and specific ‘brain training’ packages (e.g. CogPack). This component will have a maximum of 7 participants per group.

Attendance at both the psychoeducation and CT component will be recorded using our patient management software, CHIME.
Intervention code [1] 313540 0
Prevention
Comparator / control treatment
The control condition will comprise a waitlist control condition which will run for 10 consecutive weeks in duration . This waitlist period will be matched for clinician contact (i.e. a weekly phone call (or text message, if the patient cannot be contact via telephone) to check-in with patient and provide them a fun fact related to healthy brain ageing).
Control group
Active

Outcomes
Primary outcome [1] 318914 0
Feasibility of the trial design: Recruitment rates/strategy: number/per cent eligible and consented; conservative expected value of 50% (95% confidence interval, CI: 42-58%).
Timepoint [1] 318914 0
Feasibility of the trial design will be measured after completion of the trial, at approximately 12 months.
Primary outcome [2] 318953 0
Tolerability of intervention: Compliance/adherence to treatment protocol: number/per cent of participants who attend weekly for 10 consecutive weeks; percentage of intervention group completing 7 or more intervention sessions over the 10-week period.
Timepoint [2] 318953 0
Tolerability of the trial design will be measured after completion of the trial, at approximately 12 months.
Secondary outcome [1] 366410 0
Verbal learning and memory for simple information:
The Hopkins Auditory Verbal Learning Test (HVLT) will be administered to measure unstructured verbal learning and recall. Total learning over three trials will be examined and in order to obtain a measure of memory consolidation, percent retention scores (i.e., [Trial 3/ Trial 4]*100) will also be calculated (HVLT%). Alternate forms are available for this test, these will be counterbalanced.
Timepoint [1] 366410 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [2] 366529 0
Mood and anxiety screen:
The Depression Anxiety and Stress Scale (DASS-21) is a set of three self-report scales (i.e. subjective) designed to measure the emotional states of depression, anxiety and stress which are calculated by summing the scores for the relevant items. The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder.
Timepoint [2] 366529 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [3] 366530 0
Sleep: The Pittsburgh Sleep Quality Index (PSQI) will be used to measure sleep disturbance. Higher total scores (range 0–21) indicate poorer sleep quality.
Timepoint [3] 366530 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [4] 366531 0
Quality of life: The World Health Organisation Quality of Life Index (WHO-QoL) will be used to measure quality of life.
Timepoint [4] 366531 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [5] 366532 0
Wellbeing: The WHO Wellbeing Index will be used to measure wellbeing.
Timepoint [5] 366532 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [6] 366533 0
Functioning: self-rated functioning will be measured using the Instrumental Activities of Daily Living Scale.
Timepoint [6] 366533 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [7] 366534 0
Cognitive complaints: The British Columbia Cognitive Complaints Inventory (BC-CCI) is a screening tool that assesses perceived cognitive difficulties specifically in patients with Major Depressive Disorder (MDD) and related mood disorders.
Timepoint [7] 366534 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [8] 366535 0
Cognitively stimulating activities: Healthy Brain Ageing questionnaire will be used to measure the amount of cognitively stimulating activity each participant is engaged in.
Timepoint [8] 366535 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [9] 366536 0
Motivation to change: The Motivation to Change Lifestyle and Health Behaviours for Dementia - Risk Reduction Scale.
Timepoint [9] 366536 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [10] 366537 0
Service delivery: Modified YES survey
Timepoint [10] 366537 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [11] 366538 0
Informant-rated functioning: Cambridge Behavioural Inventory – Revised (CBI-R)
Timepoint [11] 366538 0
Informants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [12] 366564 0
Caregiver burden: The Zarit Burden Interview is a self-report measure of subjective burden among caregivers of adults with dementia, and subscales A and B from the Carer Well-Being Support, a questionnaire for carers of people with a mental health problem or dementia.
Timepoint [12] 366564 0
Informants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [13] 366565 0
Informant mood: The DASS-21 will be used to screen for depressive and anxiety symptoms in caregivers.
Timepoint [13] 366565 0
Informants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [14] 366566 0
Verbal learning and memory for complex information:
The story subtest from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Alternate forms are available for this test, these will be counterbalanced.
Timepoint [14] 366566 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [15] 366567 0
Visuospatial function and visual memory: the RBANS figure drawing subtest. Alternate forms (which will be counterbalanced) are available for this test.
Timepoint [15] 366567 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [16] 366568 0
Language: generativity will be assessed using letter (F, A, S) and semantic (types of animals) fluency, comprising the total number of words generated in three minutes and one minute respectively. Alternate forms of letter (C, F, L) and semantic (types of fruits and vegetables) fluency will be used and will be counterbalanced.
Timepoint [16] 366568 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [17] 366569 0
Speed: the Trail Making Test Part A (TMT-A, seconds) will be used to assess psychomotor speed.
Timepoint [17] 366569 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [18] 366570 0
Executive function: The Trail Making Test Part B (TMT-B, seconds) will be used to assess set-shifting/cognitive flexibility.
Timepoint [18] 366570 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [19] 366571 0
Executive function: the Delis–Kaplan Executive Function System (D-KEEFS) Colour Word Interference Test will be used to measure inhibition.
Timepoint [19] 366571 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [20] 366572 0
Mood screening: The Patient Health Questionnaire is a 9-question (PHQ-9) self-report (i.e. subjective) instrument given to patients in a primary care setting to screen for the presence and severity of depression. It is the 9-question depression scale from the (PHQ). The total sum of the responses suggests varying levels of depression. Scores range from 0 to 27. In general, a total of 10 or above is suggestive of the presence of depression. The PHQ-9 is also used to evaluate efficacy of treatments for depression. A change of PHQ-9 score to less than 10 is considered a “partial response” to treatment and a change of PHQ-9 score to less than 5 is considered to be indicative of “remission.”
Timepoint [20] 366572 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).
Secondary outcome [21] 366573 0
Depression: The Hamilton Depression Rating Scale (HAM-D), is a multiple item questionnaire used to measure of depression. It is rated by a clinician (i.e. objective measure of depression) on 17 items which are scored either on a 3-point or 5-point Likert-type scale. For the 17-item version, a score of 0–7 is considered to be normal while a score of 20 or higher indicates at least moderate severity of depression.
Timepoint [21] 366573 0
Participants will complete the above measures at baseline (i.e. two weeks before commencement of the intervention) and follow-up (i.e. two weeks following the intervention ceasing).

Eligibility
Key inclusion criteria
Participants eligible for Club Connect must comply with all of the following criteria:
1. Have provided written informed consent,
2. Be aged 65 years or older,
3. Have current depressive symptoms (as evidenced by 6 ore more on the Geriatric Depression Scale 15 item (GDS-15) or, history of a MDE within the last five years (assessed using the Mini International Neuropsychiatric Interview), and
4. Be willing and able to commit to attending for the duration of the program, outside of unforeseen or unanticipated circumstances (e.g. illness).

Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from participating if they have:
1. An established diagnosis of dementia,
2. A Mini Mental State Examination (MMSE) score <24 with impairment in activities of daily living,
3. Severe major depression with impaired activities of daily living, or current harmful or dependent substance use (i.e. more than recommended daily intake based on national guidelines), or current or history of a non-affective psychiatric disorder (e.g. schizophrenia etc.) that would preclude their ability to engage in a group-based CT program,
4. Had electroconvulsive therapy within the three months prior to baseline assessment, and
5. Insufficient English skills to participant in psychometric testing or in group-based CT.

Participants engaging in other therapies for the treatment of depression (i.e. non pharmacological and pharmacological therapy) will be included, yet participants on pharmacological therapy will need to be stabilised on their medication for at least four weeks before baseline assessment.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A summary of the main analyses will include:
1. Baseline data which will be summarised by treatment group using means (with standard deviations), counts and proportions, as appropriate, to understand the balance in characteristics between the randomised groups. A consort diagram will describe the flow of patients through the trial.
2. The proportion of appropriate referrals eligible and consenting participants (i.e. feasibility) and the proportion of participants in the intervention group that adhere to the treatment (complete 7 or more sessions) and complete the intervention (i.e. tolerability) will be calculated with 95% confidence intervals.
3. Clinical outcome measures will be summarised using effect sizes (and 95% confidence intervals). These analyses will inform which of the potential primary outcomes is likely to be more sensitive to the intervention. These data will also be used to inform sample size estimation for a future definitive trial.

Stop-go criteria for progression to main trial: with 35 intervention participants and 35 controls, we will achieve the following 95% confidence intervals (CI) for our expected adherence and participation estimates:
1. Proportion of participants adhering to intervention- expected value 66%, 95% CI: 58-74%.
2. Proportion of appropriate referrals consenting to the trial-expected value 50%, 95% CI:42-58%.

These confidence intervals will provide acceptable ranges to inform continuation to the main trial. Overall, we expect that our “stop-go” measures will relate to the proportion adhering to 7 or more intervention sessions over a 10-week period:
- =66% - go to main trial
- 50-65% - consider a modified trial design to increase adherence
- <50% - do not progress to main trial using this model

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/02/2019
Actual
21/02/2019
Date of last participant enrolment
Anticipated
20/09/2019
Actual
2/10/2019
Date of last data collection
Anticipated
20/12/2019
Actual
19/12/2019
Sample size
Target
70
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13030 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 25524 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 301847 0
Hospital
Name [1] 301847 0
St Vincent's Hospital, Sydney
Country [1] 301847 0
Australia
Funding source category [2] 301851 0
University
Name [2] 301851 0
The University of Sydney
Country [2] 301851 0
Australia
Funding source category [3] 301852 0
Charities/Societies/Foundations
Name [3] 301852 0
St Vincent's Clinic Foundation
Country [3] 301852 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria St
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 301593 0
University
Name [1] 301593 0
The University of Sydney
Address [1] 301593 0
The University of Sydney
NSW 2006
Country [1] 301593 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302547 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 302547 0
Ethics committee country [1] 302547 0
Australia
Date submitted for ethics approval [1] 302547 0
26/11/2018
Approval date [1] 302547 0
08/01/2019
Ethics approval number [1] 302547 0
SVH 18/258

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

Contacts
Principal investigator
Name 90602 0
Ms Claudia Woolf
Address 90602 0
Older People's Mental Health Service
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Country 90602 0
Australia
Phone 90602 0
+61 283821540
Fax 90602 0
Email 90602 0
[email protected]
Contact person for public queries
Name 90603 0
Claudia Woolf
Address 90603 0
Older People's Mental Health Service
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Country 90603 0
Australia
Phone 90603 0
+61 283821540
Fax 90603 0
Email 90603 0
[email protected]
Contact person for scientific queries
Name 90604 0
Claudia Woolf
Address 90604 0
Older People's Mental Health Service
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St
Darlinghurst NSW 2010
Country 90604 0
Australia
Phone 90604 0
+61 283821540
Fax 90604 0
+61 283821402
Email 90604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given this is a feasibility trial, releasing individual participant data is no appropriate.


What supporting documents are/will be available?

No Supporting Document Provided



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.