Clinical trial NCT06648707: Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic RCT
Official title: Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults: A Pilot Pragmatic Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Community-dwelling Seniors
Keywords: dual-task
cognitive training
Older adults
train-the-trainer
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-10-18
Enrollment: 93
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: After baseline, before randomization
measure: Attendance rate
timeFrame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
measure: Retention rate
timeFrame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
measure: Satisfaction rate
timeFrame: 6 weeks after baseline for intervention group, 12 weeks after baseline for waitlist control group.
Secondary outcomes:
measure: Completion rate of the interventionist
timeFrame: End of study, up to 2 years
measure: Time to recruit target sample size
timeFrame: Before baseline
measure: Factors influencing older adults' decision to participate and staff of the community centre to organise the activity
timeFrame: At the end of recruitment briefing, before baseline
measure: Change from baseline subjective memory complaints at 6 weeks
timeFrame: 6 weeks after baseline
measure: Change from baseline subjective memory complaints at 12 weeks
timeFrame: 12 weeks after baseline, only for waitlist control group
measure: Change from baseline working memory at 6 weeks
timeFrame: 6 weeks after baseline
measure: Change from baseline working memory at 12 weeks
timeFrame: 12 weeks after baseline, only for waitlist control group
measure: Change from baseline executive function at 6 weeks
timeFrame: 6 weeks after baseline
measure: Change from baseline executive function at 12 weeks
timeFrame: 12 weeks after baseline, only for waitlist control group
measure: Change from baseline cognitive status at 6 weeks
timeFrame: 6 weeks after baseline
measure: Change from baseline cognitive status at 12 weeks
timeFrame: 12 weeks after baseline, only for waitlist control group
measure: Qualitative feedback
timeFrame: At the end of the study, up to 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Community centre
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: Pui Hing Chau, PhD
role: PRINCIPAL_INVESTIGATOR
References: