Clinical trial NCT05822596: Tablet-based Interactive Games in Elderly With Cognitive Impairment and Persons With Intellectual Disability
Official title: The Effectiveness and Feasibility of Tablet-based Interactive Games in Elderly With Cognitive Impairment and Persons With Intellectual Disability: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Technology
Cognitive Impairments
Intellectual Disability
Keywords: Gerontechnology
Interactive games
Cognitive training
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Haven of Hope Hospital
name: The Social Innovation and Entrepreneurship Development Fund, Hong Kong
First posted: 2023-04-21
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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

Primary study questions:

1. Can the participation of 12-week cognitive training program using tablet-based interactive games maintain cognitive functioning?

   Secondary study questions:
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. Can the participation of 12-week cognitive training program using tablet-based interactive games improve the reaction time of the participants?
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. What is the usability and acceptability of the tablet-based interactive games?

   Auxiliary study questions:
6. Can the participation of 12-week cognitive training program using tablet-based interactive games reduce neuropsychiatric symptoms?
7. Can the participation of 12-week cognitive training program using tablet-based interactive games improve upper-body flexibility?
8. What are the physical side effects of using digital devices in the 12-week cognitive training program?
9. What are the perceived benefits and feasibility of the cognitive training program and tablet-based interactive games?
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?

Detailed description: Study design

The trial is a randomized controlled trial. 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, 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. The outcome indicators between joining and not joining the 12-week cognitive training program will be compared. In addition, the compliance of the participants, the perceived benefits and feasibility of the program and games will be assessed.

This protocol complies with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Guideline for Good Clinical Practice (ICH-GCP) and Declaration of Helsinki.

Procedures

1. Participants' recruitment and consent

   Elderly with Mild Cognitive Impairment (MCI) in the elderly service setting

   Elderly scoring above the cutoff for dementia in Montral Cognitive Assessment - Hong Kong (MoCA - HK) and not receiving a medical diagnosis of dementia or other mentally incapacitating disease will be classified as competent in giving consent and will be invited to give consent.

   Elderly with dementia \& Persons in the rehabilitation setting

   For elderly with dementia scoring below the cutoff in MoCA or receiving a diagnosis of mentally incapacitating disease, and persons in the rehabilitation setting, the criteria stated in the Alzheimer Europe Report (2011) will be followed to ensure that they are provided chances to give consent. In particular, four criteria will be evaluated, including 1) the person must have sufficient capacity to understand the information, 2) the person is able to retain, use and weight up such information for making a decision, 3) the person will understand the benefit, risk, and convenience, 4) the person must have the ability to communicate the decision. The University of Hong Kong (HKU) research staff and the care staff will first commit them in a causal chat to assess their ability to communicate and understand the dialogues.

   If potential participants are competent in giving consent, both potential participants and their next of kin members will be approached for consent. In cases potential participants are not competent in giving consents, only their next of kin will be approached for consent. They will then be referred to join a 1-to-1 study introduction session. In this session, HKU research staff and service unit staff will introduce the study to the participant, and invite them to sign a consent form.

   For program facilitators, written consent will be obtained from them before qualitative interviews.
2. Randomization

   After all baseline assessment are completed, participants will be individually randomized to experimental group or control group. A list of random numbers will be generated to create a list of random group allocation (either experimental or control; allocation ratio 1:1), using the RAND function of Excel. The research staff will perform the randomization procedure, by assigning consenting participants who meet all eligibility criteria to the two groups using the list.
3. Training of tablet-based interactive games for program facilitators

   A few identical 60-minute trainings on tablet-based interactive games will be delivered to the program facilitators, who will lead the cognitive training program at the study sites. During the training, they will learn how to operate the game system and lead the participants to play the games. A protocol will be provided for the facilitators in running the program.
4. Pilot run

   The first facilitated and non-facilitated sessions of the 12-week cognitive training program will be used as a pilot run to revise the test protocol and program structure.
5. Implementation

Participants in the experimental group will take part in a 12-week cognitive training program using tablet-based interactive games. The supplier will provide personal accounts to the study sites, so that program facilitators can keep track on the cognitive performance of the individual participant through system reports. Program facilitators will help participants log in the accounts at the start of the facilitated and non-facilitated sessions.

The platform has 79 mini-games that aim to train six cognitive domains, including executive function, memory, eye-hand coordination, attention, visual-spatial ability, and language. Based on the performance and ability of the user, program facilitator can choose the game difficulty level that most fit the participant. To enhance participation, the game utilizes local elements, such as old Hong Kong, supermarkets, and calligraphy. Additionally, some games allow two or more players to participate, for example Mah-jong. During playing the games, the system will assess the cognitive performance of the participants, and calculate a score for each of the six cognitive domains for the program facilitator.

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.

5.1 Facilitated sessions

There will be two 30-minute facilitated sessions each week. In each session, a program facilitator will lead 1-4 participants in playing the tablet-based interactive games. 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.

5.2 Non-facilitated sessions

In non-facilitated sessions, depending on the capability of the participants and the availability of mobile devices, the participants can play cognitive games by themselves and at their own pace for 10 - 30 minutes. In elderly service setting, there will be 0 - 4 non-facilitated sessions per week. In rehabilitation service setting, there will be 0 - 7 non-facilitated sessions per week. These sessions can be administered by staff other than the program facilitators.

5.3 Intervention for control group

During the 12-week trial, the control group will join activities other than the tablet-based interactive games as in experimental group.

To better understand the nature of the control group, the scheduled activities for the control group when the experimental group joins the 12-week training program will be collected.

Blinding

Participants and program facilitators cannot and will not be blinded to the intervention. Assessors of the outcomes will not be involved in the recruitment and intervention delivery and will be blinded to group allocation (single blindness).

Sample size determination

The sample size is estimated by the current number of eligible service users and related staff at the test sites. It is estimated that a total of 81 participants and 10 program facilitators will be recruited.

Data analysis

1. Main analysis

   Linear mixed model analysis will be used to test the interaction between group and time of the outcome indicators of cognitive functioning, reaction time, upper-body flexibility, neuropsychiatric symptoms, activities of daily living, and physical side effects of using digital devices. A partial-eta square will be used to estimate the effect size in comparing the intervention group with the control group. Linear mixed model analysis will also be used to examine the changes in the 6 supplier-developed cognitive domains over time.

   Descriptive statistics will be used to describe the attendance rate in cognitive training program, time spent on playing tablet-based interactive games, and usability and acceptability of the tablet-based interactive games.
2. Qualitative interview

The content will be transcribed verbatim in Chinese for further analysis. Transcripts will be analysed using framework analysis to construct a coherent and logical structure from the classification of many opinions and perceptions of the tablet-based interactive games. The results will then be discussed and consolidated in the panel meetings with the co-authors.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the service users in elderly service setting:

* 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

Inclusion criteria for the service users in rehabilitation service setting:

* Aged 40 or above,
* Diagnosed with intellectual disability (IQ\<70), and
* Able to understand Chinese

Inclusion criteria for the program facilitators:

* Occupational therapists of the study sites (preferably), or
* Social workers or nurses of the study sites

Exclusion Criteria:

Exclusion criteria for both types of service users:

• 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

Exclusion criteria for the program facilitators:

• Nil

Primary outcomes:
measure: Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
measure: Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
Secondary outcomes:
measure: The scores of 6 supplier-developed cognitive domains
timeFrame: From the start to the end of 12-week trial period
measure: Change of reaction time before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
measure: Attendance rate in the cognitive training program (including facilitated and non-facilitated sessions)
timeFrame: From the start to the end of 12-week trial period
measure: Time spent on playing tablet-based interactive games
timeFrame: From the start to the end of 12-week trial period
measure: The usability and acceptability of the tablet-based interactive games
timeFrame: At the end of the 12-week cognitive training program
measure: Change of neuropsychiatric symptoms before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
measure: Change of upper-body flexibility before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
measure: Change of physical side effects before and after using digital device
timeFrame: Baseline and at the end of 12-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of participants
timeFrame: At the end of 12-week trial period
measure: Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of program facilitators
timeFrame: At the end of 12-week trial period
measure: Change of the activities in daily living of person with intellectual disability before and after using the tablet-based interactive games
timeFrame: Baseline and at the end of 12-week trial period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Day Care cum Rehabilitation Centre for Elderly (Hong Kong West/ Hong Kong East)
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Nursing Home
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Rehabilitation Services for Disabled
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Sister Annie Skau Holistic Care Centre
city: Hong Kong
country: Hong Kong
facility: Haven of Hope Woo Ping Care & Attention Home
Study officials:
affiliation: The University of Hong Kong
name: Yee Tak Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
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