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Trial registered on ANZCTR


Registration number
ACTRN12621000900819
Ethics application status
Approved
Date submitted
26/04/2020
Date registered
12/07/2021
Date last updated
16/06/2022
Date data sharing statement initially provided
12/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and Impact Study of Dayakattai Cognitive Stimulation Technique (DaCST) for Older Adults with and Without Cognitive Disorders.
Scientific title
Feasibility and Impact Study of Dayakattai Cognitive Stimulation Technique (DaCST) for Older Adults with and Without Cognitive Disorders.
Secondary ID [1] 300839 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 316724 0
Dementia 316727 0
Condition category
Condition code
Neurological 314972 314972 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. BRIEF NAME: Dayakattai Cognitive Stimulation Technique (DaCST).

2. WHY: It was found that some of the major challenges endured by older adults with and without cognitive disorders include poor quality of life, cognitive deterioration and low mood which may negatively affect their overall psychological well-being as an individual. Moreover, researches have shown that older adults in aged care facilities experience more detrimental effects in the areas stated. In order to improve this poor psychosocial condition, the present research will be using the Indian board game ‘Dayakattai’ as a cultural-based Cognitive Stimulation Technique (DaCST).

3. WHAT: Materials (Dayakattai board game made from washable cotton, 24 pieces of pawns/coins made from wood, 2 pieces of cuboid shaped dice made from wood).

4. Procedures:
- All players start with six chips at a 'home' in the center of the board. They each take turns rolling the ‘Daayam’, a pair of dice that are shaped like long cuboids. They are typically made of wood and have dots punched onto the long faces (1, 2, 3, 0).

- When a player rolls the ‘Daayam’ (0 on one dice, 1 on the other), they get to move one of their pieces one space out of their home and roll again and they advance their piece by the number indicated by the dice.

- For all the pieces to move out of the home, ‘Daayam’ has to be rolled out till all pieces are out. Pieces advance along with the board by initially moving down their owner's leg of the board, and then in a clockwise direction.

- When a player rolls a one, five, six, or twelve (two 0s), they get to roll again. The numbers rolled can be distributed among the player's pieces (e.g. A player rolls 5, 12, 2. They can move one piece by twelve, move another by 5, and then move one more by 2).

- Pieces can 'cut' other pieces by landing on the same spot that they are in. A 'cut' piece is sent all the way back to the home. However, while on one of the safe zones on the board (marked by an X), a piece cannot be cut.

- After completing one lap, a piece starts to move up the outer edge of the right side of its owner's leg of the game board. It stays on the corners instead of the spaces.

- The piece then needs to move the exact number of spaces to get to the center of the board.

- While at the corner of the home, a piece can be cut by another piece getting to the corner of its home.

- Players win by getting all of their pieces to the center of the board.

5. WHO PROVIDED: The researcher will be the moderator/facilitator of DaCST. She is a certified Clinical Psychologist who has the knowledge, skills and experience in dealing with conflict management for 5 years. The moderator/facilitator is required to acquire skills such as being person-centered and flexible. Other responsibilities of a moderator/facilitator include guiding the participants in terms of who’s turn is it to roll the dice, show cue cards on the numbers that would allow players to move their pawn into the board. Overall, a moderator/facilitator is responsible to enhance individual and group dynamic while ensuring the players follow the rule of the games. Moderator/facilitator are also responsible to engage and facilitate group interaction while playing the game. Lastly, it is crucial for moderator/facilitator to maintain a safe, fun and optimal environment.

6. HOW: Mode of delivery (The DaCST is played face-to-face in a group with a minimum of two players and a maximum of four players at a time).

7. WHERE: Nursing homes/aged care facilities in West Malaysia (Negeri Sembilan, Kuala Lumpur and Selangor).

8. WHEN and HOW MUCH: DaCST will be conducted once/week, for 8 consecutive weeks. Each session will be conducted for 30-45 minutes.

9. TAILORING:
i) The game has no facilitator/moderator by its own. However, the researcher will be playing the role of the facilitator/moderator to assist the participants and to maintain a safe, fun and optimal environment.

ii) Cue cards with numbers will be shown to aid participants.

iii) The adherence strategy will be used for this study is by monitoring attendance for every session intervention conducted. A special attendance form will be used to monitor and record keeping. Fun and motivation also part of promoting adherence to the DaCST activity.
participant lists for each session

10. MODIFICATIONS: N/A

HOW WELL
11. Planned: N/A
12. Actual: N/A
Intervention code [1] 317164 0
Prevention
Intervention code [2] 317165 0
Rehabilitation
Intervention code [3] 317166 0
Treatment: Other
Comparator / control treatment
Active: no treatment given
Control group
Active

Outcomes
Primary outcome [1] 323282 0
Quality of life measured using The World Health Organization Quality of Life (WHOQOL-BREF) questionnaire (English and Malay version-validated). The following domains will be measured: Domain 1 (Physical Health), Domain 2 (Psychological), Domain 3 (Social Relationship), Domain 4 (Environment).
Timepoint [1] 323282 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Primary outcome [2] 323391 0
Cognitive functioning measured using Addenbrooke’s Cognitive Examination III (ACE- III) questionnaire (English and Malay version-validated). ACE-III contains five sub-scores, each one representing one cognitive domain: attention/orientation (18 points), memory (26 points), fluency (14 points), language (26 points) and visuospatial (16 points).
Timepoint [2] 323391 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Primary outcome [3] 323392 0
Mood will be measured using the Geriatric Depression Scale (GDS-14) (English and Malay version-validated). Scores of 0-4 are considered normal; 5-8 indicate mild depression; 9-11 indicate moderate depression and 12-15 in dictate severe depression
Timepoint [3] 323392 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Secondary outcome [1] 381754 0
UCLA Loneliness Scale (ULS-8) measures one’s subjective feelings of loneliness and their feelings of social isolation (English and Malay version-validated).
Timepoint [1] 381754 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Secondary outcome [2] 390127 0
The Revised Index of Social Engagement (RISE) measures the social involvement of residents with other residents in care homes, professional caregivers and relatives (English version-validated; Malay version-to be validated).
Timepoint [2] 390127 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Secondary outcome [3] 390128 0
Self esteem will be measured using the Rosenberg Self-Esteem Scale (RSES). It measures global self-worth by measuring both positive and negative feelings about the self (English and Malay version-validated).
Timepoint [3] 390128 0
Baseline assessment will be done, Followed by intervention once/week for 8 weeks, Post assessment (Week 8) to measure the effect of intervention. Follow up assessment 14 weeks from baseline.
Secondary outcome [4] 390129 0
Qualitative Questions (one-on-one interview);

Qualitative Interview Questions (English version)
– “What is the first thing that crossed your mind when you saw this game?”
– “Does playing the game bring back childhood memories of you playing the game with others?” (Indian participants)
– “What do you think/feel remembering those childhood memories?” (Indian participants)
– “How did you feel being part of the program?”
– “What was your experience playing this game with the other residents?”
– “What have you learned/insight that you gained through this game?
– “In what way this game has changed your life?”
– “Do you want to continue playing this game with the other residents?”


Soalan Temuduga Kualitatif (Malay version)

– "Apakah perkara pertama yang melintasi fikiran anda apabila anda melihat permainan ini?"
– "Adakah bermain ‘Dayakattai’ membawa kenangan zaman kanak-kanak bermain permainan ini dengan orang lain?" (Peserta India)
– "Apakah perasaan anda mengingati kenangan zaman kanak-kanak anda?" (Peserta India)
– "Bagaimana perasaan anda menjadi peserta program ini?"
– "Apakah pengalaman anda bermain permainan ini dengan peserta lain?"
– "Apakah yang telah anda pelajari / peroleh melalui permainan ini?
– "Bagaimana permainan ini mengubah kehidupan anda?"
– "Adakah anda mahu terus bermain permainan ini dengan peserta lain?"
Timepoint [4] 390129 0
At week 8 (at the end of intervention). An interview will be conducted in order for every participant to share their personal experiences in being part of the program).

Eligibility
Key inclusion criteria
Indian participants between the ages of 60-89 years old with prior experience playing the ‘Dayakattai’ game during their childhood days will be recruited for this study. The study population will be divided into two main groups, whereby participants with cognitive disorders will comprise of MCI and mild to moderate dementia population whereas without cognitive disorders group will include healthy older adults. Participants in Group 1 must fulfill the diagnosis of mild to moderate dementia. Participants in Group 2 must fulfil the diagnosis of MCI. Study 1 and Study 2 participants are also required to fulfil the diagnosis criteria based on DSM-5 for MCI and dementia respectively (APA 2013). As for participants in Group 3, all the older adults must be healthy individuals.
All the participants must be from aged care facility. Furthermore, participants are required to be within the age range of 60-89. In terms of language proficiency, each participant is required to have sufficient command of Malay or English. In addition, sufficient insight to be able to complete questionnaires and interview are also and important requirement.
Minimum age
60 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants with severe sensory impairments such as poor/uncorrected vision/hearing will be excluded. In addition, participants with high level of psychomotor agitation: e.g., pacing, tremors, hand wringing/fidgeting will be excluded as well. Participants from the MCI and dementia groups who have mental disorder comorbidities will not be included in this study.

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)
A simple randomization using a computer-generated random numbers will be used to randomize each participants into treatment and standard care group based on gender (male and female) and types of cognitive disorders (healthy individuals, MCI and dementia).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
This is single blind randomised control trial. Participants will be randomly assigned to either treatment or standard care group. Only participant in treatment group will receive DaCST intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way mixed ANOVA will be used to measure the overall feasibility of DaCST among Indian older adults with MCI and dementia (types of cognitive disorders: MCI and dementia) in the treatment and standard care group (types of intervention: treatment and standard care). The feasibility of the intervention will be tested using the pre and post outcome measure.

Three-way mixed ANOVA will be used to analyse the gender differences (male and female), types of cognitive disorders (MCI, dementia and healthy individuals) and types of intervention (treatment and standard care) with pre and post-test measurement on the changes in quality of life, cognitive functioning, mood, self-esteem and social interaction. In order to intervene complications such as noncompliance and missing outcomes with regards to RCT, Intention-To-Treat (ITT) analysis will be applied.

Qualitative study/data
The qualitative part of the study will provide support to the quantitative study. Further more, the qualitative study findings will strengthen the effectiveness of the intervention among participants in the treatment groups.

All participants in the treatment groups will be interviewed one-on-one using a list of semi structured interview questions.

Analysis
The interview will be analysed using Framework Analysis by Ritchie and Spencer (1994), which aims to elicit an individual’s experience of an event through a number of distinct but interconnected stages of analysis. There are five key stages: (i) Familiarisation, (ii) Identifying a thematic framework, (iii) Indexing, (iv) Charting and (v) Mapping and Interpretation. In the first stage, the transcripts will be read thoroughly in order for the researcher to become familiar with the broad themes expressed. The broad themes that will emerge will be compiled and refined leading to a coding key, which will include sub-themes. Each transcript will then be categorised using the coding key, and codes will be continually re-assessed and re-interpreted. Next, a chart of themes and sub-themes will be developed and further modified until the dominant themes emerged. Finally, themes will be mapped and interpreted.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
2/01/2020
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
176
Accrual to date
16
Final
Recruitment outside Australia
Country [1] 22446 0
Malaysia
State/province [1] 22446 0
Negeri Sembilan
Country [2] 22447 0
Malaysia
State/province [2] 22447 0
Kuala Lumpur
Country [3] 22448 0
Malaysia
State/province [3] 22448 0
Selangor

Funding & Sponsors
Funding source category [1] 305296 0
University
Name [1] 305296 0
Universiti Kebangsaan Malaysia
Country [1] 305296 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Universiti Kebangsaan Malaysia, 43600 UKM, Bangi, Selangor, Malaysia
Country
Malaysia
Secondary sponsor category [1] 308173 0
None
Name [1] 308173 0
Address [1] 308173 0
Country [1] 308173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305634 0
Research Ethics Committee, The National University of Malaysia
Ethics committee address [1] 305634 0
Ethics committee country [1] 305634 0
Malaysia
Date submitted for ethics approval [1] 305634 0
10/10/2019
Approval date [1] 305634 0
21/11/2019
Ethics approval number [1] 305634 0
NN-2019-150

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

Contacts
Principal investigator
Name 101034 0
Dr Ponnusamy Subramaniam
Address 101034 0
Centre for Healthy Ageing and Wellness ,
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101034 0
Malaysia
Phone 101034 0
+60039289 8185
Fax 101034 0
N/A
Email 101034 0
ponnusaami@ukm.edu.my
Contact person for public queries
Name 101035 0
Ponnusamy Subramaniam
Address 101035 0
Centre for Healthy Ageing and Wellness ,
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101035 0
Malaysia
Phone 101035 0
+60039289 8185
Fax 101035 0
N/A
Email 101035 0
ponnusaami@ukm.edu.my
Contact person for scientific queries
Name 101036 0
Ponnusamy Subramaniam
Address 101036 0
Centre for Healthy Ageing and Wellness ,
Faculty of Health Sciences
Universiti Kebangsaan Malaysia
Jalan Raja Muda Abdul Aziz
50300 Kuala Lumpur
Country 101036 0
Malaysia
Phone 101036 0
+60039289 8185
Fax 101036 0
N/A
Email 101036 0
ponnusaami@ukm.edu.my

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7509Ethical approval    379494-(Uploaded-04-04-2020-15-36-30)-Study-related document.pdf
7510Ethical approval    379494-(Uploaded-04-04-2020-15-39-29)-Study-related document.pdf



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.