Cost-effectiveness of Self-administered Dual-task Training (sDTT) for Reducing Falls Among Older Adults: A Multi-centre-randomized Controlled Trial With Economic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Number of falls
研究概览
简要总结
Evidence supports that dual-task training reduces fall risk among older adults. However, the current framework for preventive care for fall prevention in Hong Kong does not include formal cognitive training, while little to no emphasis is placed on combining physical and cognitive training (dual tasking) to prevent falls. Secondly, the healthcare costs for eligible Hong Kong citizens are subsidised by between 81 and 97% of the actual treatment cost. Therefore, there is a demanding need for cost-effective treatment to reduce the country's' economic burden. This project will assist policymakers and clinicians in recommending cost-effective treatments for fall prevention.
详细描述
Objective: Evaluate the effectiveness and cost-effectiveness of self-administered dual-task training (sDTT) for preventing falls among older adults and promote this technique to the target population and healthcare workers of Hong Kong.
Design: In Phase 1, a multi-centre randomised controlled trial (RCT) with economic evaluation will evaluate the effectiveness and cost-effectiveness. In Phase 2, the technique will be promoted through hands-on workshops for older adults and helpers; and promotional talks with physiotherapists and rehabilitation nurses.
Setting: Community-based elderly care centres. Participants: For the RCT, we will recruit 190 community-dwelling older (≥65 years) adults of both genders having experienced at least one fall in the past 6 months. 500 community-dwelling older adults will be recruited for the workshop and 100 healthcare workers will be engaged for promotion activities.
Intervention: In Phase 1, the experimental group will receive sDTT from a physiotherapist once every 2 weeks for 12 weeks. They will perform home exercises once per week for 12 weeks. Unsupervised exercises will then continue over the next 6 months. Control group will receive the same amount of self-administered single-task training as the experimental group.
Primary outcome measure: Number of falls will be assessed at baseline (T1), post-intervention after 12 weeks (T2) and 6 months (T3). Health promotion will be assessed using a knowledge and attitude questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
A person not involved in the study (student helper #1) will randomise the participants using a random number list prepared by Dr Chen Huijun Cynthia (statistician) before the baseline assessment. One HK-registered physiotherapist (RA1) will be recruited to conduct workshops on teaching the exercise interventions to all participants. One research postgraduate (RPg) student will be recruited to conduct all of the other methodological procedures involved in the project. Assessments will be performed by an existing postgraduate student of the PI, who is blind to treatment condition. An economic evaluation with healthcare utility estimation will be performed by Dr Chen Huijun Cynthia. The treatment allocation coding will be unblinded following the completion of the study.
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
- •Community-dwelling
- •Ambulant with or without the use of a walking assistive device
- •Have experienced at least one fall over the past 6 months and
- •Obtained a mini-mental state examination score of ≥ 24 (indicating the absence of cognitive impairment).
排除标准
- •Have been diagnosed with dementia or Alzheimer's disease,
- •Have a previous history of psychiatric illness
- •Are only able to walk with hand-held support
- •Have a severe visual impairment that prevents exercise participation.
研究组 & 干预措施
Self administered dual-task training
The exercise intervention will continue for 9 months, beginning with 12 weeks of training accompanied by workshops to teach the exercises.
Experimental group: sDTT group participants will be instructed to perform 10 minutes of warm-up, 40 minutes of dual-task training and 10 minutes of cool-down exercises. The size of the workshop will be limited to 10 participants. The sDTT programme includes performing a selection of six cognitive tasks during walking, the sit-to-stand movement, heel and toe raising, stepping, tandem standing and walking and multidirectional reaching tasks. The cognitive tasks will include mental tracking, working memory, auditory cues and verbal fluency tasks. Participants will be given the freedom to mix and match the physical and cognitive tasks to make them more challenging.
干预措施: Falls prevention exercises (Behavioral)
Self-administered singletask training
Control group: The self-administered single-task training group will receive 10 minutes of warm-up, 20 minutes of physical tasks (as outlined above) and 20 minutes of cognitive tasks (as outlined above) followed by 10 minutes of cool-down exercises. Participants will be instructed to perform the exercises for the same dosage as the experimental group. After a 6-month follow-up period, the control group will receive two complimentary sessions of self-administered dual-task training.
干预措施: Falls prevention exercises (Behavioral)
结局指标
主要结局
Number of falls
时间窗: Change score at week 12 and week 36
The number of falls will be recorded from the baseline using each participant's digital diary interface. Participants will be instructed to record the number of falls on a weekly basis. The baseline assessment of falls will be calculated as the number of falls over the past 3 months from the day of study enrolment
次要结局
- Falls Efficacy Scale- International (FES-I)(Change score at week 12 and week 36)
- 12-item Short Form Health Survey (SF-12)(Change score at week 12 and week 36)
- Dual-task cost of balance performance will be assessed for the TUG(Change score at week 12 and week 36)
- Dual-task cost of cognitive performance will be assessed for the TUG(Change score at week 12 and week 36)
- Berg Balance Scale (BBS)(Change score at week 12 and week 36)
- Montreal Cognitive Assessment (MoCA)(Change score at week 12 and week 36)
- EuroQol 5 dimension 5 level EQ5D5L(Change score at week 12 and week 36)