Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486285
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-18
Brief Title:
Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss
Sponsor:
The Hong Kong Polytechnic University
Organization:
The Hong Kong Polytechnic University
Study Overview
Official Title:
Auditory-Cognitive Dual-Task Intervention for Older Adults With Hearing Loss A Pilot Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Age-related hearing loss ARHL is a common and irreversible condition that has been recently associated with cognitive decline and dementia Hence if ARHL is treated earlier the risk of dementia might decrease However in China only 08 of older adults with hearing loss wore hearing aids and over two-thirds 675 of older adults with ARHL in Hong Kong had either been formally diagnosed or treated There is also limited information on the feasibility and efficacy of hearing loss interventions for older people in Hong Kong It is important to develop hearing loss interventions that have the potential to improve cognitive functions among older people
Aims This study aims to assess the feasibility and acceptability of a new auditory-cognitive dual-task intervention ACDT for community-dwelling older adults with hearing loss and to examine the preliminary efficacy of ACDT on their cognitive function
Study design and Methods This is mixed-model design using a 2-arm parallel-group single-blinded pilot randomized controlled trial pilot RCT A total of 60 community-dwelling older adults in Hong Kong who have mild to moderate hearing loss and normal cognitive performance will be recruited Participants will be randomly assigned to the auditory-cognitive dual-task intervention group ACDTG and control group with no specific intervention a wait list group CG Each ACDTG participant will receive the intervention for 12 weeks 5 days x 60-min sessions per day All participants in all groups will be assessed for cognitive function primary outcome social isolation and loneliness and hearing at baseline T0 and after the intervention T1 Post-intervention interviews will be conducted to obtain perspectives of participants in the ACDTG on the feasibility and acceptability of the ACDT intervention
Data analysis Participant characteristics and outcome variables will be analysed through descriptive statistics Differences in cognition score and other outcomes across time points among the participant groups will be measured by Generalized Estimating Equations GEE The statistical software package IBM SPSS version 260 will be used Content analysis will used to analyse the post-intervention interviews
Expected results ACDT will be feasible for implementation and acceptable for community-dwelling older adults with hearing loss While ACDT will not be able to improve underlying hearing in ARHL it will be more effective on improving participants cognitive function social engagement and loneliness and ability in information processing interpretation and communication than CG
Aims This study aims to assess the feasibility and acceptability of a new auditory-cognitive dual-task intervention ACDT for community-dwelling older adults with hearing loss and to examine the preliminary efficacy of ACDT on their cognitive function
Study design and Methods This is mixed-model design using a 2-arm parallel-group single-blinded pilot randomized controlled trial pilot RCT A total of 60 community-dwelling older adults in Hong Kong who have mild to moderate hearing loss and normal cognitive performance will be recruited Participants will be randomly assigned to the auditory-cognitive dual-task intervention group ACDTG and control group with no specific intervention a wait list group CG Each ACDTG participant will receive the intervention for 12 weeks 5 days x 60-min sessions per day All participants in all groups will be assessed for cognitive function primary outcome social isolation and loneliness and hearing at baseline T0 and after the intervention T1 Post-intervention interviews will be conducted to obtain perspectives of participants in the ACDTG on the feasibility and acceptability of the ACDT intervention
Data analysis Participant characteristics and outcome variables will be analysed through descriptive statistics Differences in cognition score and other outcomes across time points among the participant groups will be measured by Generalized Estimating Equations GEE The statistical software package IBM SPSS version 260 will be used Content analysis will used to analyse the post-intervention interviews
Expected results ACDT will be feasible for implementation and acceptable for community-dwelling older adults with hearing loss While ACDT will not be able to improve underlying hearing in ARHL it will be more effective on improving participants cognitive function social engagement and loneliness and ability in information processing interpretation and communication than CG
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None