Tablet-based Interactive Games in Elderly With Cognitive Impairment and Persons With Intellectual Disability

NCT05822596 | Completed

• 1 other identifier: Tablet games_protocol_v1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 5

Brief Summary

The study has 10 research questions regarding the cognitive training program and tablet-based interactive games: Primary study questions:

1. 1.Can the participation of 12-week cognitive training program using tablet-based interactive games maintain cognitive functioning?
2. 2.Can the participation of 12-week cognitive training program using tablet-based interactive games improve the scores of 6 supplier-developed cognitive domains (including executive function, memory, eye-hand coordination, attention, visual-spatial ability, language)?
3. 3.Can the participation of 12-week cognitive training program using tablet-based interactive games improve the reaction time of the participants?
4. 4.What is the attendance rate in the cognitive training program, and for how long do the participants play the tablet-based interactive games?
5. 5.What is the usability and acceptability of the tablet-based interactive games?
6. 6.Can the participation of 12-week cognitive training program using tablet-based interactive games reduce neuropsychiatric symptoms?
7. 7.Can the participation of 12-week cognitive training program using tablet-based interactive games improve upper-body flexibility?
8. 8.What are the physical side effects of using digital devices in the 12-week cognitive training program?
9. 9.What are the perceived benefits and feasibility of the cognitive training program and tablet-based interactive games?
10. 10.Can the participation of 12-week cognitive training program using tablet-based interactive games improve activities of daily living of persons with intellectual disability?

Conditions

Technology; Cognitive Impairments; Intellectual Disability

Keywords

Gerontechnology; Interactive games; Cognitive training

Outcome Measures

Primary Outcomes (2)

• Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games

  Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to group allocation. Total nine items on Hong Kong Brief Cognitive Test (HKBC) will be completed at the baseline and the end of 12-week trial period and the minimum and maximum scores are 0 and 30 respectively.

  Baseline and at the end of 12-week trial period

• Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games

  Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games will be assessed by HKU research staff who is blinded to the group allocation. Total twenty-one items on 21-item Short Form of the Prudhoe Cognitive Function Test (SF-PCFT) will be completed at the baseline and the end of 12-week trial period and the minimum and maximum scores are 0 and 30 respectively.

  Baseline and at the end of 12-week trial period

Secondary Outcomes (11)

• The scores of 6 supplier-developed cognitive domains

  From the start to the end of 12-week trial period

• Change of reaction time before and after using the tablet-based interactive games

  Baseline and at the end of 12-week trial period

• Attendance rate in the cognitive training program (including facilitated and non-facilitated sessions)

  From the start to the end of 12-week trial period

• Time spent on playing tablet-based interactive games

  From the start to the end of 12-week trial period

• The usability and acceptability of the tablet-based interactive games

  At the end of the 12-week cognitive training program

Study Arms (2)

Tablet-based interactive games experimental group

EXPERIMENTAL

The experimental group will take part in a 12-week cognitive training program using tablet-based interactive games.

Device: Tablet-based interactive games experimental group intervention

Control group

NO INTERVENTION

The control group will receive treatment as usual during the 12-week trial.

Interventions

Tablet-based interactive games experimental group intervention DEVICE

The program consists of 24 facilitated sessions and, depending on the capability of the participants, the availability of mobile devices and the service setting, 0 - 84 non-facilitated sessions. In 30-minute facilitated session, a program facilitator will lead 1-8 participants in playing the tablet-based interactive games and helpers (e.g., health workers, program workers, and volunteers) will assist the program facilitator in running the sessions. The games may be played individually or together with other participants. In non-facilitated sessions, the participants can play cognitive games depending on the capability of themselves and at their own pace for 10 - 30 minutes

Tablet-based interactive games experimental group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with mild to moderate dementia by doctors, or scoring at least 5 and lower than the norm-derived age and education adjusted cutoff scores 7th percentile in HK-MoCA (i.e. elderly with MCI, mild dementia and moderate dementia), and
• Able to understand Chinese
• Aged 40 or above,
• Diagnosed with intellectual disability (IQ\<70), and
• Able to understand Chinese
• Occupational therapists of the study sites (preferably), or
• Social workers or nurses of the study sites

You may not qualify if:

• Inability to join the intervention program due to severe mental illness, behavior problems, sight impairment, hearing impairment, or communication impairment, as determined by the program facilitator
• Nil

Sponsors & Collaborators

• The University of Hong Kong: lead
• Haven of Hope Hospital: collaborator
• The Social Innovation and Entrepreneurship Development Fund, Hong Kong: collaborator

Study Sites (5)

Haven of Hope Day Care cum Rehabilitation Centre for Elderly (Hong Kong West/ Hong Kong East)

Hong Kong, 00, Hong Kong

Location

Haven of Hope Nursing Home

Hong Kong, 00, Hong Kong

Location

Haven of Hope Rehabilitation Services for Disabled

Hong Kong, 00, Hong Kong

Location

Haven of Hope Sister Annie Skau Holistic Care Centre

Hong Kong, 00, Hong Kong

Location

Haven of Hope Woo Ping Care & Attention Home

Hong Kong, 00, Hong Kong

Location

Related Publications (5)

• Chiu HFK, Zhong BL, Leung T, Li SW, Chow P, Tsoh J, Yan C, Xiang YT, Wong M. Development and validation of a new cognitive screening test: The Hong Kong Brief Cognitive Test (HKBC). Int J Geriatr Psychiatry. 2018 Jul;33(7):994-999. doi: 10.1002/gps.4883. Epub 2018 Apr 11.

  PMID: 29642275 BACKGROUND

• Katz-Leurer M, Fisher I, Neeb M, Schwartz I, Carmeli E. Reliability and validity of the modified functional reach test at the sub-acute stage post-stroke. Disabil Rehabil. 2009;31(3):243-8. doi: 10.1080/09638280801927830.

  PMID: 18608433 BACKGROUND

• Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.

  PMID: 11001602 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Tyrer SP, Wigham A, Cicchetti D, Margallo-Lana M, Moore PB, Reid BE. Comparison of short and long versions of the Prudhoe Cognitive Function Test and the K-BIT in participants with intellectual impairment. J Autism Dev Disord. 2010 Aug;40(8):1000-5. doi: 10.1007/s10803-010-0949-3.

  PMID: 20143147 BACKGROUND

Related Links

• Human Benchmark (2023, Jan 26). Reaction Time Test. Human Benchmark.

MeSH Terms

Conditions

Cognitive Dysfunction; Intellectual Disability

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Study Officials

• Yee Tak Cheung, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of the outcomes will not be involved in the recruitment and intervention delivery and will be blinded to group allocation (single blindness).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: The participants will be randomly allocated into either intervention group and control group in a 1:1 allocation ratio. The target participants are residents in elderly residential settings, members in day care units for the elderly, and persons with intellectual disabilities in day activity centre cum hostel. Participants in the experimental group will participate in a 12-week cognitive training program that includes facilitated sessions and non-facilitated sessions.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 21, 2023
• Study Start: June 12, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 10, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available for 10 years.

Locations

HK (5)