Clinical trial NCT05533333: Self-administered Dual-task Training for Reducing Falls Among the Older Adults
Official title: Cost-effectiveness of Self-administered Dual-task Training (sDTT) for Reducing Falls Among Older Adults: A Multi-centre-randomized Controlled Trial With Economic Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Older Adults
Keywords: Falls
Older adults
Dual-task
Balance
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: National University of Singapore
First posted: 2022-09-09
Enrollment: 190
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assessor-blinded, multi-centre parallel-group RCT with economic evaluation
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Analysis: General linear mixed model with maximum likelihood estimation will compare primary and secondary outcome measures. Cost-effectiveness will be assessed from the Hong Kong healthcare perspective. Wilcoxon Signed-Rank test will assess the benefits of health promotion.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of falls
timeFrame: Change score at week 12 and week 36
Secondary outcomes:
measure: Dual-task cost of balance performance will be assessed for the TUG
timeFrame: Change score at week 12 and week 36
measure: Dual-task cost of cognitive performance will be assessed for the TUG
timeFrame: Change score at week 12 and week 36
measure: Berg Balance Scale (BBS)
timeFrame: Change score at week 12 and week 36
measure: Falls Efficacy Scale- International (FES-I)
timeFrame: Change score at week 12 and week 36
measure: 12-item Short Form Health Survey (SF-12)
timeFrame: Change score at week 12 and week 36
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Change score at week 12 and week 36
measure: EuroQol 5 dimension 5 level EQ5D5L
timeFrame: Change score at week 12 and week 36
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
state: Kowloon
Study officials:
References: