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NCT Number: NCT06648707

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

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.

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Key information

Conditions

Community-dwelling Seniors

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Attendance rate

    Time frame: 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.

  3. Retention rate

    Time frame: 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.

  4. Satisfaction rate

    Time frame: 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 outcomes

  1. Completion rate of the interventionist

    Time frame: 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

  2. Time to recruit target sample size

    Time frame: Before baseline

    The time needed to recruit target sample size is defined as the time taken to recruit required sample size in each centre.

  3. Factors influencing older adults' decision to participate and staff of the community centre to organise the activity

    Time frame: 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

  4. Change from baseline subjective memory complaints at 6 weeks

    Time frame: 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.

  5. Change from baseline subjective memory complaints at 12 weeks

    Time frame: 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.

  6. Change from baseline working memory at 6 weeks

    Time frame: 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.

  7. Change from baseline working memory at 12 weeks

    Time frame: 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.

  8. Change from baseline executive function at 6 weeks

    Time frame: 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.

  9. Change from baseline executive function at 12 weeks

    Time frame: 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.

  10. Change from baseline cognitive status at 6 weeks

    Time frame: 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.

  11. Change from baseline cognitive status at 12 weeks

    Time frame: 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.

  12. Qualitative feedback

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Hing Chau, PhD

CONTACT

[email protected]

3917 6626

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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