The Effectiveness and Feasibility of Tablet-based Interactive Games in Elderly With Cognitive Impairment and Persons With Intellectual Disability: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games
研究概览
简要总结
The study has 10 research questions regarding the cognitive training program and tablet-based interactive games:
Primary study questions:
- 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?
详细描述
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
- Participants' recruitment and consent
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors of the outcomes will not be involved in the recruitment and intervention delivery and will be blinded to group allocation (single blindness).
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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:
研究组 & 干预措施
Control group
The control group will receive treatment as usual during the 12-week trial.
Tablet-based interactive games experimental group
The experimental group will take part in a 12-week cognitive training program using tablet-based interactive games.
干预措施: Tablet-based interactive games experimental group intervention (Device)
结局指标
主要结局
Change of cognitive functioning of elderly without intellectual disability before and after using the tablet-based interactive games
时间窗: Baseline and at the end of 12-week trial period
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.
Change of cognitive functioning of person with intellectual disability before and after using the tablet-based interactive games
时间窗: 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 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.
次要结局
- Change of the activities in daily living of person with intellectual disability before and after using the tablet-based interactive games(Baseline and at the end of 12-week trial period)
- Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of participants(At 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)
- Change of upper-body flexibility before and after using the tablet-based interactive games(Baseline and at the end of 12-week trial period)
- The scores of 6 supplier-developed cognitive domains(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)
- Change of neuropsychiatric symptoms before and after using the tablet-based interactive games(Baseline and at the end of 12-week trial period)
- Change of physical side effects before and after using digital device(Baseline and at the end of 12-week trial period)
- Qualitative measures: The perceived benefits and feasibility of the cognitive training program and tablet-based interactive games of program facilitators(At the end of 12-week trial period)
研究者
Dr. Derek Yee-Tak Cheung
Principal Investigator, Assistant Professor
The University of Hong Kong