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

NCT06648707 | Recruiting

• 1 other identifier: UW 23-575
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Community-dwelling Seniors

Keywords

dual-task; cognitive training; Older adults; train-the-trainer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Completion rate of the interventionist

  End of study, up to 2 years

• Time to recruit target sample size

  Before baseline

• 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

• Change from baseline subjective memory complaints at 6 weeks

  6 weeks after baseline

• Change from baseline subjective memory complaints at 12 weeks

  12 weeks after baseline, only for waitlist control group

Study Arms (2)

Assigned intervention

OTHER

The intervention group will start 6 week dual-task invention immediately after baseline.

Other: Dual-task training

Assigned waitlist control

OTHER

The control group will start 6 week dual-task invention after the follow-up assessment 6 weeks after baseline.

Other: Dual-task training

Interventions

Dual-task training OTHER

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.

Assigned intervention; Assigned waitlist control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• contraindications to chair-based or stepping exercises.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Community centre

Hong Kong, Hong Kong

RECRUITING

Study Officials

• Pui Hing Chau, PhD

  School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui Hing Chau, PhD

CONTACT

3917 6626; phpchau@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 18, 2024
• Study Start: October 21, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)