Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000993291
Ethics application status
Approved
Date submitted
24/01/2018
Date registered
13/06/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a computerized cognitive training program in enhancing cognitive function and reducing frailty in older Chinese people
Scientific title
Evaluation of a computerized cognitive training program in enhancing cognitive function and reducing frailty in older Chinese people: A randomized controlled trial
Secondary ID [1] 293704 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 306050 0
Condition category
Condition code
Neurological 305190 305190 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention groups will be asked to perform the computerized cognitive training (video game training) over 12 weeks with two 30-minute training sessions in each week (with at least a day between sessions) in community centres. The training will be delivered by trained research assistants, supervised by the centre social worker. Adherence to the intervention will be monitored through direct observation by study staff as well as accessing program analytics.

There will be two training groups:
• Computerized cognitive training program - five domains
It includes a set of 12 iPad mini-games which are designed to provide training and practice on a variety of tasks related to five specific cognitive domains: memory, attention, executive function, flexibility and visuospatial ability. These domains were chosen because of their importance in functional activities. During each training session, participants will be asked to play three mini-games related to the same cognitive domain. The difficulty of each game will be gradually increased according to each individual’s performance during the previous session.

• Computerized cognitive training program - two domains
Only mini-games designed to train memory and attention will be used. Similarly, participants will be asked to play three mini-games related to the same cognitive domain during each training session.
Intervention code [1] 299958 0
Prevention
Comparator / control treatment
Participants in the control group will be invited to watch a series of DVDs about art, science, history etc., and answered multiple choice questions that required careful listening and focused attention to the DVD content over 12 weeks with two 30-minute training sessions in each week.
Control group
Active

Outcomes
Primary outcome [1] 304345 0
Change in cognitive function (Visual memory function).

Visual reproduction will be used to assess visual memory function. Participants are required to learn five sets of geometric forms, and then draw them from memory after 30 minutes. The total score in terms of accuracy rate at a delayed recall was adopted for analyses.
Timepoint [1] 304345 0
Week 12
Primary outcome [2] 306263 0
Change in frailty status.

Frailty will be measured using the FRAIL scale. There are 5 components: fatigue, resistance, ambulation, illnesses, and loss of weight. Frailty scores range from 0 to 5 (i.e., 1 point for each component; 0 = best to 5 = worst) and represent robust (0), pre-frail (1-2), and frail (3-5) health statuses.
Timepoint [2] 306263 0
Week 12
Secondary outcome [1] 348003 0
Change in cognitive function (Rate of learning).

Hong Kong list learning will be used to assess rate of learning (acquisition). Participants requires learning a list of 16 Chinese words through three learning trials, all of the words are two-character nouns. The test requires the interviewer to verbally present words at a rate of one word per second. After 10-mins delay, participants will be asked to recall as many words as possible. The total number of recalled words after a delay was used to reflect verbal memory ability.
Timepoint [1] 348003 0
Week 12
Secondary outcome [2] 348007 0
Change in cognitive function (Rate of forgetting).

Hong Kong list learning will be used to assess rate of forgetting (retention). Participants requires learning a list of 16 Chinese words through three learning trials, all of the words are two-character nouns. The test requires the interviewer to verbally present words at a rate of one word per second. After 10-mins delay, participants will be asked to recall as many words as possible. The total number of recalled words after a delay was used to reflect verbal memory ability.
Timepoint [2] 348007 0
Week 12
Secondary outcome [3] 348009 0
Change in cognitive function (Attention/working memory).

Wechsler digit span task will be used to assess attention/working memory. This test requires the interviewer to verbally present digits at a rate of one per second. The forward test requires the participant to repeat the digits verbatim. The backward test requires the participant to repeat the digits in reverse order.
Timepoint [3] 348009 0
Week 12
Secondary outcome [4] 348010 0
Change in cognitive function (Visual attention/executive function).

Colour trails test will be used to assess visual attention/executive function. Colour trails test-1 requires participants to connect numbers in ascending order as quickly as possible. Colour trails test-2 requires alternation between two different sets of stimuli, numbers and two colours (1-pink, 2-yellow, 3-pink, etc.).
Timepoint [4] 348010 0
Week 12
Secondary outcome [5] 348012 0
Change in cognitive function (Executive function).

Frontal assessment battery will be used to assess executive function. This test is a short instrument testing 6 subtest domains which are related to the functions of the frontal lobe. The six questions are related to conceptualization, mental flexibility, motor programming, sensitivity to interference, inhibitory control and environmental autonomy.
Timepoint [5] 348012 0
Week 12
Secondary outcome [6] 348013 0
Ability test performance will be measured using each participant’s level of accuracy when taking four ability tests.

Accuracy will be measured using the number of correct responses participants give when taking four iPad ability tests.
Timepoint [6] 348013 0
Week 12
Secondary outcome [7] 348014 0
Ability test performance will be measured using each participant’s reaction times when taking four ability tests.

Reaction times will be measured using the response times of the same four iPad ability tests.
Timepoint [7] 348014 0
Week 12
Secondary outcome [8] 348015 0
Game performance will be measured using participants’ level of accuracy when playing each game.

Accuracy will be measured using the number of correct responses given by the participants for each game.
Timepoint [8] 348015 0
Week 12
Secondary outcome [9] 348016 0
Game performance will be measured using participants’ reaction time when playing each game.

Reaction time will be measured using the participants’ response times for each game.
Timepoint [9] 348016 0
Week 12

Eligibility
Key inclusion criteria
People aged 50 years or older will be identified in community facilities (e.g., neighborhood elderly centre, social centre for the elderly) and invited for a brief screening using the FRAIL scale. Those meeting the criteria for potential pre-frailty or frailty according to their FRAIL score (score greater than or equal to one) will be invited for further assessment. To be eligible for the study, the subjects should further fulfill the following criteria:

Inclusion criteria
- People aged 50 years or older;
- FRAIL score greater than or equal to one and thus are considered pre-frail or frail;
- Chinese origin;
- Normally reside in Hong Kong;
- Could speak and understand Chinese;
- Willing to follow the study procedures.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Live in a residential aged care facility;
- Recent (i.e. past 3 months) or concurrent participation in any clinical trial or cognitive and/or exercise and/or dietary intervention program;
- With medical advice or conditions prohibiting exercise or medical conditions that precluded safe participation in an exercise program;
- With any other indication of a major medical or psychological illness, judged by the investigators as ineligible to participate the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will first be checked for their eligibility for the study. Written informed consent will be obtained from all participants. Eligible participants will receive a baseline assessment in the community facilities, prior to intervention. Eligible participants will be randomly assigned to participate in cognitive training / DVD watching classes. The participants will not be blinded to the treatment assignment. Outcome measurements will be collected at two time points, namely baseline and 12 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
2/07/2018
Date of last participant enrolment
Anticipated
30/04/2019
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
270
Accrual to date
195
Final
Recruitment outside Australia
Country [1] 9470 0
Hong Kong
State/province [1] 9470 0

Funding & Sponsors
Funding source category [1] 298322 0
University
Name [1] 298322 0
The Chinese University of Hong Kong
Country [1] 298322 0
Hong Kong
Primary sponsor type
Individual
Name
Ruby Yu
Address
CUHK Jockey Club Institute of Ageing, Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 297437 0
None
Name [1] 297437 0
Address [1] 297437 0
Country [1] 297437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299315 0
Joint CUHK-NTEC Clinical Research Ethics Committee
Ethics committee address [1] 299315 0
8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Ethics committee country [1] 299315 0
Hong Kong
Date submitted for ethics approval [1] 299315 0
10/10/2017
Approval date [1] 299315 0
18/01/2018
Ethics approval number [1] 299315 0
2017.577

Summary
Brief summary
To investigate the effectiveness of a 12-week computerized cognitive training program in enhancing cognitive function and reducing frailty in community-dwelling Chinese pre-frail or frail older people.

It is anticipated that a 12-week frailty program will enhance cognitive function and frailty status in pre-frail or frail older people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80026 0
Dr Ruby Yu
Address 80026 0
CUHK Jockey Club Institute of Ageing, Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Country 80026 0
Hong Kong
Phone 80026 0
+852 39435142
Fax 80026 0
Email 80026 0
[email protected]
Contact person for public queries
Name 80027 0
Dr Ruby Yu
Address 80027 0
CUHK Jockey Club Institute of Ageing, Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Country 80027 0
Hong Kong
Phone 80027 0
+852 39435142
Fax 80027 0
Email 80027 0
[email protected]
Contact person for scientific queries
Name 80028 0
Dr Ruby Yu
Address 80028 0
CUHK Jockey Club Institute of Ageing, Suite 602, 6/F, Yasumoto International Academic Park, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Country 80028 0
Hong Kong
Phone 80028 0
+852 39435142
Fax 80028 0
Email 80028 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
SourceTitleYear of PublicationDOI
EmbaseRandomized controlled trial on the effects of a combined intervention of computerized cognitive training preceded by physical exercise for improving frailty status and cognitive function in older adults.2021https://dx.doi.org/10.3390/ijerph18041396
N.B. These documents automatically identified may not have been verified by the study sponsor.