Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648707
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults a Pilot Pragmatic RCT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dual-task Training to Prevent Cognitive Decline in Community-dwelling Older Adults a Pilot Pragmatic Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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 11 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None