Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT

Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Community-dwelling Seniors
• Intervention / Treatment: Other: Dual-task training

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pui Hing Chau, PhD; Phone Number: 3917 6626; Email: phpchau@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Community centre
    • Contact: Pui Hing Chau; Phone Number: 3917 6626; Email: phpchau@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

(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.

Exclusion Criteria:

contraindications to chair-based or stepping exercises.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assigned intervention; The intervention group will start 6 week dual-task invention immediately after baseline.	Other: Dual-task training; Participants will receive a one-hour face-to-face group-based dual-task training session twice a week for 6 weeks. Training included cognitive components and physical components to be conducted simultaneously.
Other: Assigned waitlist control; The control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline.	Other: Dual-task training; Participants will receive a one-hour face-to-face group-based dual-task training session twice a week for 6 weeks. Training included cognitive components and physical components to be conducted simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	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.	After baseline, before randomization
Attendance rate	Attendance rate is defined as the number of attended intervention sessions collected in attendance log divided by the number of planned intervention sessions.	6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Retention rate	Retention rate is defined as the number of participants completing the post-intervention assessment divided by the number of participants at baseline.	6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Satisfaction rate	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.	6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion rate of the interventionist	The number of nominated staff/volunteers considered as completing the project divided by the total number of nominated staff/volunteers	End of study, up to 2 years
Time to recruit target sample size	The time needed to recruit target sample size is defined as the time taken to recruit required sample size in each centre.	Before baseline
Factors influencing older adults' decision to participate and staff of the community centre to organise the activity	Reasons of the older adults and staff of the community centres for joining or not joining the study	At the end of recruitment briefing, before baseline
Change from baseline subjective memory complaints at 6 weeks	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.	6 weeks after baseline
Change from baseline subjective memory complaints at 12 weeks	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.	12 weeks after baseline, only for waitlist control group
Change from baseline working memory at 6 weeks	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.	6 weeks after baseline
Change from baseline working memory at 12 weeks	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.	12 weeks after baseline, only for waitlist control group
Change from baseline executive function at 6 weeks	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.	6 weeks after baseline
Change from baseline executive function at 12 weeks	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.	12 weeks after baseline, only for waitlist control group
Change from baseline cognitive status at 6 weeks	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.	6 weeks after baseline
Change from baseline cognitive status at 12 weeks	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.	12 weeks after baseline, only for waitlist control group
Qualitative feedback	Qualitative feedback on facilitators and barriers of organising the activity will be collected from one representative of each participating centre by semi-structured interview.	At the end of the study, up to 2 years

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Pui Hing Chau, PhD, School of Nursing, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Older adults; dual-task; cognitive training; train-the-trainer
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: UW 23-575

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No