Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Objectives:
This study aims to explore the feasibility and acceptance of group-based dual-task training for prevention of cognitive decline in a pragmatic setting for community-dwelling older adults.
The primary objective is to assess recruitment rate, attendance rate, retention rate and satisfaction rate of participants.
Study design and participants:
This is a pilot pragmatic RCT with waitlist control. First, a co-design approach will be adopted to develop the intervention with the older adults. Then, about six participating community centres will nominate staff or volunteer to receive the training in order to lead the intervention. Informed consent will be sought from the participants and baseline assessment will be conducted. The participants will be randomly allocated to the intervention and control groups in 1:1 ratio using block randomisation with varying block size. At the end of the study, one representative of each participating centre will be invited to provide qualitative feedback.
Measurements:
The primary outcomes are the feasibility outcomes, namely the recruitment rate, attendance rate, the retention rate, and satisfaction rate of participants. Secondary outcomes include completion rate of the interventionist, time to recruit target sample size, factors influencing older adults' decision to participate and staff of the community centre to organise the activity, subjective memory complaints, working memory, executive function, and cognitive status of participants. A structured questionnaire will be used to collect quantitative outcomes related to effects and satisfaction. Qualitative feedback from representatives of the elderly community centres will be collected according to a semi-structured interview guide.
Expected results: The intervention is feasible and highly accepted by the participants and staff of the community centres. Potential effect-related outcomes are to be demonstrated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(i) aged 65 years and above,
- •(ii) eligible to enrol in activities organised by the community centres,
- •(iii) no communication problems,
- •(iv) able to understand and follow instructions,
- •(v) able to read and write Chinese.
排除标准
- •contraindications to chair-based or stepping exercises.
研究组 & 干预措施
Assigned waitlist control
The control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline.
干预措施: Dual-task training (Other)
Assigned intervention
The intervention group will start 6 week dual-task invention immediately after baseline.
干预措施: Dual-task training (Other)
结局指标
主要结局
Recruitment rate
时间窗: After baseline, before randomization
Recruitment rate is defined as the number of participants agreed to join the study before randomization divided by the number of potential participants who completed recruitment briefing.
Attendance rate
时间窗: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Attendance rate is defined as the number of attended intervention sessions collected in attendance log divided by the number of planned intervention sessions.
Retention rate
时间窗: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Retention rate is defined as the number of participants completing the post-intervention assessment divided by the number of participants at baseline.
Satisfaction rate
时间窗: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Satisfaction to the project will be measured by a question using 5-point Likert scale (very satisfactory to very unsatisfactory). Satisfaction rate is defined as the number of participants rating the intervention a score of ≥4 out of 5 divided by the number of participants started intervention.
次要结局
- Completion rate of the interventionist(End of study, up to 2 years)
- Time to recruit target sample size(Before baseline)
- Factors influencing older adults' decision to participate and staff of the community centre to organise the activity(At the end of recruitment briefing, before baseline)
- Change from baseline subjective memory complaints at 6 weeks(6 weeks after baseline)
- Change from baseline subjective memory complaints at 12 weeks(12 weeks after baseline, only for waitlist control group)
- Change from baseline working memory at 6 weeks(6 weeks after baseline)
- Change from baseline working memory at 12 weeks(12 weeks after baseline, only for waitlist control group)
- Change from baseline executive function at 6 weeks(6 weeks after baseline)
- Change from baseline executive function at 12 weeks(12 weeks after baseline, only for waitlist control group)
- Change from baseline cognitive status at 6 weeks(6 weeks after baseline)
- Change from baseline cognitive status at 12 weeks(12 weeks after baseline, only for waitlist control group)
- Qualitative feedback(At the end of the study, up to 2 years)
研究者
Dr. Pui-Hing Chau
Associate Professor
The University of Hong Kong