Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001173684p
Ethics application status
Submitted, not yet approved
Date submitted
29/09/2023
Date registered
14/11/2023
Date last updated
14/11/2023
Date data sharing statement initially provided
14/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Maintaining Social Engagement: A social cognitive skills intervention for older adults with cognitive concerns.
Scientific title
A randomised controlled trial to determine the effect of a social cognitive skills intervention on cognitive and mental health for older adults with cognitive concerns
Secondary ID [1] 310694 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dementia 331633 0
mild cognitive impairment 331634 0
anxiety 331635 0
depression 331999 0
Condition category
Condition code
Neurological 328362 328362 0 0
Dementias
Neurological 328720 328720 0 0
Other neurological disorders
Mental Health 328721 328721 0 0
Anxiety
Mental Health 328722 328722 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5 x 2-hour sessions involving online group social cognitive skills intervention with older adults with cognitive concerns and their care partners. The sessions cover topics such as communication skills (including verbal and non-verbal communication), managing sensory and cognitive challenges, assertive and respectful communication, maintaining good relationships, and goal setting. The facilitator will be a psychologist.

Additional points:
a) Participants will receive access via an emailed Zoom link
b) A random selection of group sessions will be recorded to be checked for fidelity to the intervention by an independent rater
c) There will be 3-5 participants per group
d) The overall time period of the intervention will be 2-hour weekly sessions over 5 weeks = 10 hours in total
e) The mode of administration will be short videos, powerpoint slides, and facilitated group discussions
Intervention code [1] 327109 0
Treatment: Other
Intervention code [2] 327110 0
Lifestyle
Intervention code [3] 327111 0
Behaviour
Comparator / control treatment
Participants will receive 5 x 2-hour online sessions of active control in groups of 3-4 facilitated weekly. The facilitator with be a psychologist. The control condition group will watch segments from documentaries and engage in group discussions about the documentaries.

2. Additional points for the control group::
a) Participants will be provided access via an emailed Zoom link
b) A random selection of group sessions will be recorded to be checked for fidelity to the control condition by an independent rater
c) The documentaries will cover 5-10 min videos on the following topics: intergenerational social interactions; cooking; gardening; animals; pets; food; travel; music; tv/movies.

3. The control group will also have care partners (optional participation, as with the intervention group).
Control group
Active

Outcomes
Primary outcome [1] 336203 0
Social Cognition
Timepoint [1] 336203 0
Baseline, 1 week post-intervention (primary timepoint) and 3 months post-intervention completion
Secondary outcome [1] 427313 0
General cognition
Timepoint [1] 427313 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [2] 427315 0
Loneliness
Timepoint [2] 427315 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [3] 427316 0
Social isolation
Timepoint [3] 427316 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [4] 427317 0
Quality of life
Timepoint [4] 427317 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [5] 427318 0
Depression
Timepoint [5] 427318 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [6] 427319 0
Anxiety
Timepoint [6] 427319 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [7] 427320 0
Social behaviour
Timepoint [7] 427320 0
Baseline, and 1 week post-intervention and 3 months post-intervention completion
Secondary outcome [8] 427321 0
Apathy
Timepoint [8] 427321 0
Baseline, and 1 week and 3 months post-intervention completion
Secondary outcome [9] 427322 0
Social cognition
Timepoint [9] 427322 0
Baseline, and 1 week and 3 months post-intervention completion
Secondary outcome [10] 428695 0
Behavioural changes associated with dementia
Timepoint [10] 428695 0
Baseline, 1 week post-intervention and 3 months post-intervention completion

Eligibility
Key inclusion criteria
People with cognitive impairment:
• Aged 55 years or older
• Cognitive complaints: Noticed changes in memory/thinking OR living with mild cognitive impairment or early stages of dementia
• Feeling lonely sometimes
• Able to join online sessions using a computer or tablet

Care partners:
• Care partner for a person with cognitive complaints participating in the study
• Able to join online sessions using a computer or tablet
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with cognitive impairment:
• Participants that do not meet the above criteria
• Memory loss or aphasia that prevents them from having conversations
• Inability to manage basic activities of daily living independently
• English below conversational level
• Sensory loss not compensated for by visual/hearing aids
• A severe psychiatric diagnosis (such as psychosis)
• Life expectancy under 12 months
• Being located outside of Australia


Care partners:
• Participants that do not meet the above criteria
• Memory loss or aphasia that prevents them from having conversations
• Inability to manage basic activities of daily living independently
• English below conversational level
• Sensory loss not compensated for by visual/hearing aids
• A severe psychiatric diagnosis (such as psychosis)
• Life expectancy under 12 months
• Being located outside of Australia

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
Stratified randomisation: participants will be stratified by age group (55-74 years old vs. 75+), sex (male/other vs female); and cognitive status (subjective cognitive complaints vs. mild cognitive impairment or dementia).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/01/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 314910 0
Charities/Societies/Foundations
Name [1] 314910 0
Dementia Australia Research Foundation
Country [1] 314910 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney High St Kensington NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 316918 0
None
Name [1] 316918 0
Address [1] 316918 0
Country [1] 316918 0
Other collaborator category [1] 282826 0
University
Name [1] 282826 0
University of Queensland
Address [1] 282826 0
The University of Queensland St Lucia 4072 Australia
Country [1] 282826 0
Australia
Other collaborator category [2] 282827 0
Commercial sector/Industry
Name [2] 282827 0
Silver Chain Group Limited
Address [2] 282827 0
Silverchain House. 6 Sundercombe Street, Osborne Park WA 6017
Country [2] 282827 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313903 0
UNSW HREC
Ethics committee address [1] 313903 0
Ethics committee country [1] 313903 0
Australia
Date submitted for ethics approval [1] 313903 0
18/09/2023
Approval date [1] 313903 0
Ethics approval number [1] 313903 0

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

Contacts
Principal investigator
Name 129734 0
Dr Suraj Samtani
Address 129734 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 129734 0
Australia
Phone 129734 0
+61 293480170
Fax 129734 0
Email 129734 0
s.samtani@unsw.edu.au
Contact person for public queries
Name 129735 0
Suraj Samtani
Address 129735 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 129735 0
Australia
Phone 129735 0
+61 293480170
Fax 129735 0
Email 129735 0
s.samtani@unsw.edu.au
Contact person for scientific queries
Name 129736 0
Suraj Samtani
Address 129736 0
Centre for Healthy Brain Ageing (CHeBA), School of Clinical Medicine, Discipline of Psychiatry & Mental Health, UNSW Medicine and Health, Level 3, AGSM (G27), Gate 11, Botany Street UNSW SYDNEY 2052 AUSTRALIA
Country 129736 0
Australia
Phone 129736 0
+61 293480170
Fax 129736 0
Email 129736 0
s.samtani@unsw.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
The ethics approval states that data will not be shared for secondary research purposes


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20539Study protocol  s.samtani@unsw.edu.au
20540Informed consent form  s.samtani@unsw.edu.au
20541Ethical approval  s.samtani@unsw.edu.au



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.