Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001320842
Ethics application status
Approved
Date submitted
26/07/2021
Date registered
28/09/2021
Date last updated
28/09/2021
Date data sharing statement initially provided
28/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility RCT of a virtual version of Club Connect: a healthy brain ageing cognitive training program for 'at-risk' older adults
Scientific title
A feasibility RCT of a virtual version of Club Connect: a healthy brain ageing cognitive training program for 'at-risk' older adults
Secondary ID [1] 304872 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild cognitive impairment 322989 0
major depression 322990 0
Condition category
Condition code
Neurological 320557 320557 0 0
Neurodegenerative diseases
Mental Health 320558 320558 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CT intervention, Virtual Club Connect, has previously been adapted from an evidence-based program and will comprise of two-hour weekly CT group sessions for 10 consecutive weeks including psychoeducation and computer-based CT. The group Virtual Club Connect sessions will have a maximum of 8 participants per group and be run via Zoom video conferencing. They will follow the format below:
I. Psychoeducation (50 minutes): 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. All material will be delivered by multidisciplinary specialists (Clinical Neuropsychologists, Old Age Psychiatrists etc). Participants will receive a booklet with the slides to be presented at each session.
II. 10-minute break: clinicians will encourage a break, where clinicians will leave the virtual room. This affords an opportunity for informal relationship-building and social support.
III. CT (50 minutes): The CT intervention will be delivered by Clinical Neuropsychologists and other clinicians within the Older People’s Mental Health Service. The computer-based CT will use Posit Science’s BrainHQ training program (https://www.brainhq.com/). Each participant will be provided with a unique log-in and access the BrainHQ website using their internet browser. Participants will engage in cognitive training activities (i.e. games, activities, puzzles etc.) on BrainHQ on their individual devices at the same time, while remaining in the zoom meeting with a facilitator present. This will ensure regular, supervised computer-based CT time, will allow for troubleshooting of specific CT exercises, and enable participants to access the known benefits of computer-based CT virtually.
Adherence will be monitored and measured each week, using a session attendance checklist.
Intervention code [1] 321264 0
Prevention
Comparator / control treatment
The treatment-as-usual control group will include a waitlist period that will be matched for clinician contact with a weekly phone call (approximately 10-20 minutes in duration), or if uncontactable via telephone by text message to provide a general 'check-in'. All participants (whether contacted by telephone or not) will be sent an email that provides information on known risk factors for cognitive decline (i.e. diet, exercise, cardiovascular health, socialisation, mood, sleep etc).
Control group
Active

Outcomes
Primary outcome [1] 328381 0
The primary outcomes relate to study feasibility and include:
1. Feasibility of the trial design: Recruitment rates/strategy: number/per cent eligible and consented by audit of study enrolment logs.
Timepoint [1] 328381 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Primary outcome [2] 328546 0
The primary outcomes relate to study feasibility and include:
2. Tolerability: adherence to treatment protocol i.e. number/percent of sessions attended over a 10-week intervention period and number/percent of participants who completed baseline and follow-up assessments assessed by audit of session attendance checklists.
Timepoint [2] 328546 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Primary outcome [3] 328547 0
The primary outcomes relate to study feasibility and include:
3. Acceptability: the acceptability of the treatment protocol: random allocation, data collection procedures etc, as perceived by clinical staff and patients, measured using a standardised questionnaire designed specifically for this study.
Timepoint [3] 328547 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [1] 398818 0
The secondary outcomes relate to evaluating sensitive clinical outcomes and measurement tools using effect sizes (and 95% confidence intervals); this will inform appropriate sample size for an adequately powered definitive trial evaluation. Participants will complete the following measures at baseline and follow-up to determine which clinical outcomes and measurement tools are most sensitive to the intervention:
• Cognition: We will use The Cambridge Neuropsychological Test Automated Battery (CANTAB)
Timepoint [1] 398818 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [2] 399371 0
• Mood:
- The Depression Anxiety and Stress Scale (DASS-21)


Timepoint [2] 399371 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [3] 399372 0
• Sleep: The Pittsburgh Sleep Quality Index (PSQI)
Timepoint [3] 399372 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [4] 399373 0
• Quality of life: The World Health Organisation Quality of Life Index (WHO-QoL)
Timepoint [4] 399373 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [5] 399374 0
• Wellbeing: The WHO Wellbeing Index
Timepoint [5] 399374 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [6] 399375 0
• Functioning: self-rated functioning will be measured using the Late Life Function and Disability Instrument (LLFDI) – disability component short-form

Timepoint [6] 399375 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [7] 399376 0
• Cognitive complaints: The British Columbia Cognitive Complaints Inventory (BC-CCI)
Timepoint [7] 399376 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [8] 399377 0
• Memory Strategies: The Multifactorial Memory Questionnaire Use of Memory Strategies subscale (MMQ-Strategy)
Timepoint [8] 399377 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [9] 399378 0
• Brain Knowledge Quiz: The Healthy Brain Ageing Multiple Choice Knowledge Quiz
Timepoint [9] 399378 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [10] 399379 0
Additional primary outcome:

4. Economic analysis: identify, measure, and value all relevant resources used (i.e. costs to the participants, costs to the health service) and health effects (benefits) (especially those commonly used for health decision-making i.e., the utility-based and disease-generic quality of life measure called EuroQol or EQ5D5, by calculating difference between resource uses and costs, economic benefit such as quality adjusted life years (QALYS)).
Timepoint [10] 399379 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [11] 401038 0
• Mood:
- The Patient Health Questionnaire (PHQ-9)
Timepoint [11] 401038 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [12] 401039 0
• Mood:
- The Hamilton Depression Rating Scale (HAM-D)
Timepoint [12] 401039 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)
Secondary outcome [13] 401040 0
• Quality of life: EuroQol five-dimensional (EQ-5D) questionnaire
Timepoint [13] 401040 0
Immediate post intervention follow-up (i.e. within 2 weeks of the intervention ceasing)

Eligibility
Key inclusion criteria
Inclusion criteria: Participants eligible for Virtual Club Connect must comply with all the following criteria:
1. Willingness to give written informed consent,
2. Be aged 65 years or older,
3. Live within the St Vincent’s Hospital catchment area, or the Prince of Wales Mental Health catchment area
4. Have current subjective cognitive complaints, scoring 3 or more on the Questionnaire of Cognitive Complaints AND/OR have current depressive symptoms, scoring 6 or more of the Geriatric Depression Scale-15, assessed over the telephone,
5. Have access to a desktop computer or laptop, webcam and internet at home that supports software required to participate in the study, and
6. Be willing and able to commit to attending for the duration of the program. If a participant does not attend for >2 sessions (outside of unforeseen or unanticipated circumstances (e.g. illness)), their ongoing participation will be discussed with them.

Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Participants will be excluded from participating if they have:
1. An established diagnosis of dementia, with impairment in activities of daily living,
2. A score of <14 on the telephone version of the Montreal Cognitive Assessment (t-MoCA)
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 six months prior to baseline assessment, and
5. Insufficient English skills to participant in psychometric testing or in group-based CT.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/07/2021
Date of last participant enrolment
Anticipated
29/04/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309246 0
Charities/Societies/Foundations
Name [1] 309246 0
St Vincent's Clinic Foundation
Country [1] 309246 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] 310215 0
None
Name [1] 310215 0
N/A
Address [1] 310215 0
N/A
Country [1] 310215 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309091 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 309091 0
390 Victoria St, Darlinghurst NSW 2010
Ethics committee country [1] 309091 0
Australia
Date submitted for ethics approval [1] 309091 0
Approval date [1] 309091 0
23/06/2021
Ethics approval number [1] 309091 0

Summary
Brief summary
The use of cognitive training to target neuropsychological dysfunction in ‘at-risk’ patients including individuals with depression, and/or with subjective or objective cognitive impairment (including those with diagnosed mild cognitive impairment) represents a promising therapeutic option in the absence of any existing treatment. However, there remains a paucity of cognitive training programs being offered in public mental health settings, and in the context of a global pandemic, face-to-face interventions remain suspended.
While our group has recently demonstrated feasibility, tolerability and acceptability for our group-based, face-to-face cognitive training program, due to the restrictions resulting from the current pandemic, we have been unable to continue to offer this valuable intervention to vulnerable older people. There is now an urgent need to evaluate whether we can deliver this intervention in a virtual mode for 'at-risk' older adults, who are now presenting in increased numbers due to the pandemic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112942 0
Ms Claudia Woolf
Address 112942 0
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St, Darlinghurst NSW 2010
Country 112942 0
Australia
Phone 112942 0
+61283821540
Fax 112942 0
Email 112942 0
[email protected]
Contact person for public queries
Name 112943 0
Ms Claudia Woolf
Address 112943 0
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St, Darlinghurst NSW 2010
Country 112943 0
Australia
Phone 112943 0
+61283821540
Fax 112943 0
Email 112943 0
[email protected]
Contact person for scientific queries
Name 112944 0
Ms Claudia Woolf
Address 112944 0
Level 4, O'Brien Centre, St Vincent's Hospital
390 Victoria St, Darlinghurst NSW 2010
Country 112944 0
Australia
Phone 112944 0
+61283821540
Fax 112944 0
Email 112944 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


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.