Self-administered Dual-task Training for Reducing Falls Among the Older Adults

Older Adults Clinical Trial

— sDTT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05533333
• Other study ID #: 0034640
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: The Hong Kong Polytechnic University
• Contact: Stanley J Winser, PhD
• Phone: +85227666746
• Email: stanley.j.winser[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Older Adults

Intervention

Behavioral:
• Falls prevention exercises
A dual-task activity involves the simultaneous performance of two activities involving physical and cognitive tasks.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (3)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	National University of Singapore, The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of falls	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	Change score at week 12 and week 36
Secondary	Dual-task cost of balance performance will be assessed for the TUG	Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard TUG)/ Standard-TUG) × 100.	Change score at week 12 and week 36
Secondary	Dual-task cost of cognitive performance will be assessed for the TUG	Based on the scores of the standard TUG (single task), d-TUG (dual-task TUG) test and standard counting backwards, the dual-task cost of balance performance will be estimated using the formula: (d-TUG - Standard counting backwards)/ Standard counting backwards) × 100.	Change score at week 12 and week 36
Secondary	Berg Balance Scale (BBS)	The functional balance will be assessed using the 14 item Berg Balance Scale. The Berg Balance Scale has a minimum score of 0 and a maximum of 56 with higher the score better the balance.	Change score at week 12 and week 36
Secondary	Falls Efficacy Scale- International (FES-I)	The fear of falls will be assessed using the Falls Efficacy Scale- International (FES-I). This self-reported scale requires the user to rate 16 items between 1 and 4 where 1 implies no difficulty and 4 indicates maximum difficulty. The scale is scored from 16 to 64 with higher the scores indicating higher concerns of falling	Change score at week 12 and week 36
Secondary	12-item Short Form Health Survey (SF-12)	The quality of life will be assessed using the 12-item Short Form Health Survey (SF-12) questionnaire. This self-reported questionnaire requires users to complete 12 questions that covers eight domains relevant to general measure of health. An online calculator will be used to derive the final score	Change score at week 12 and week 36
Secondary	Montreal Cognitive Assessment (MoCA)	Montreal Cognitive Assessment (MoCA) estimates memory, executive function, attention, language, abstraction, naming, delayed recall and orientation. This brief tool scores cognitive function out of 30, with a higher score equating to better function.	Change score at week 12 and week 36
Secondary	EuroQol 5 dimension 5 level EQ5D5L	Health status will be assessed using the EuroQol-5-dimension-5-level (EQ-5D-5L). It is a standardised measure of health status used for economic appraisal. The Chinese translated version of the EQ 5D 5L will be used.	Change score at week 12 and week 36