Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT
- Conditions
- Community-dwelling Seniors
- Registration Number
- NCT06648707
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 93
(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.
contraindications to chair-based or stepping exercises.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment rate 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Completion rate of the interventionist End of study, up to 2 years The number of nominated staff/volunteers considered as completing the project divided by the total number of nominated staff/volunteers
Time to recruit target sample size Before baseline The time needed to recruit target sample size is defined as the time taken to recruit required sample size in each centre.
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 Reasons of the older adults and staff of the community centres for joining or not joining the study
Change from baseline subjective memory complaints at 6 weeks 6 weeks after baseline Subjective memory complaints will be measured by the 27-item Memory Inventory in Chinese (Lui et al., 2006). Participants response on the frequency of complaints related to daily living in the past month, using 0 (none) to 4 (continuously). The scale ranges from 0 to 108, higher score indicates more memory complaints.
Change from baseline subjective memory complaints at 12 weeks 12 weeks after baseline, only for waitlist control group Subjective memory complaints will be measured by the 27-item Memory Inventory in Chinese (Lui et al., 2006). Participants response on the frequency of complaints related to daily living in the past month, using 0 (none) to 4 (continuously). The scale ranges from 0 to 108, higher score indicates more memory complaints.
Change from baseline working memory at 6 weeks 6 weeks after baseline Working memory will be measured by Digit Span Test (Leung et al., 2011). The participants will repeat the digits series which are gradually longer. In both the forward and the backward test, the longer the series, the better the condition.
Change from baseline working memory at 12 weeks 12 weeks after baseline, only for waitlist control group Working memory will be measured by Digit Span Test (Leung et al., 2011). The participants will repeat the digits series which are gradually longer. In both the forward and the backward test, the longer the series, the better the condition.
Change from baseline executive function at 6 weeks 6 weeks after baseline Executive function will be measured by Chinese version of the Victoria Stroop Test (Lee and Chan, 2000). The completion time and number of errors that the participants made in naming the colour in the presence of different stimuli (number dots, words unrelated to color, words related to color) will be recorded, with more time and errors as worse condition.
Change from baseline executive function at 12 weeks 12 weeks after baseline, only for waitlist control group Executive function will be measured by Chinese version of the Victoria Stroop Test (Lee and Chan, 2000). The completion time and number of errors that the participants made in naming the colour in the presence of different stimuli (number dots, words unrelated to color, words related to color) will be recorded, with more time and errors as worse condition.
Change from baseline cognitive status at 6 weeks 6 weeks after baseline Cognitive status will be measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol. The validated assessment test covers four domains: attention, executive functions/language, orientation, and memory (Yeung et al., 2014). The total score ranges from 0 to 30; a higher score indicates better cognitive status.
Change from baseline cognitive status at 12 weeks 12 weeks after baseline, only for waitlist control group Cognitive status will be measured by the Montreal Cognitive Assessment 5-Minutes (Hong Kong Version) (HK-MoCA 5-Min) protocol. The validated assessment test covers four domains: attention, executive functions/language, orientation, and memory (Yeung et al., 2014). The total score ranges from 0 to 30; a higher score indicates better cognitive status.
Qualitative feedback At the end of the study, up to 2 years Qualitative feedback on facilitators and barriers of organising the activity will be collected from one representative of each participating centre by semi-structured interview.
Trial Locations
- Locations (1)
Community centre
🇭🇰Hong Kong, Hong Kong