Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569836
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Evaluation Study for the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation Study for the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management
Status:
RECRUITING
Status Verified Date:
2024-08
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 evaluate the effectiveness of the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management with a view to developing sustainable strategies of self-management on chronic conditions integrating with tele-rehabilitation technology
Study design and participants
An evaluation study adopting a randomized controlled trial design with waitlist attention control will be conducted in Elderly community centres of Hong Kong Sheng Kung Hui Welfare Council and Christian Family Service Centre CFSC in Hong Kong The proposed sample size is 858 participants which is a convenience sample from the service user of the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management At least 15 participants will be invited for qualitative interview
Participants will be randomized to the intervention group or the waitlist attention control group in 11 ratio using block randomization with random block size of 4 6 and 8 stratified by each centre and severity of condition A researcher independent to the project will generate the randomization sequence by computer and keep the list Participants in the intervention group known as Group A to the participants will start the 12-week intervention immediately whereas the waitlist attention control know as Group B to the participants will start the intervention after 12 weeks During the waiting period waitlist control receives attention control
Measurements
The primary outcome of this study is quality of life It will be measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale WHOQOL-BREF
The secondary outcomes are pain physical functioning emotional functioning adherence rate satisfaction score rate of adverse events in relation to the intervention and cost-effectiveness of the intervention
Expected results
The improvement in health-related quality of life of older adults is larger in the intervention group as compared to the control group The relief in knee pain of older adults is larger in the intervention group as compared to the control group The improvement in physical functioning of older adults is larger in the intervention group as compared to the control group The improvement in emotional functioning of older adults is larger in the intervention group as compared to the control group
This study aims to evaluate the effectiveness of the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management with a view to developing sustainable strategies of self-management on chronic conditions integrating with tele-rehabilitation technology
Study design and participants
An evaluation study adopting a randomized controlled trial design with waitlist attention control will be conducted in Elderly community centres of Hong Kong Sheng Kung Hui Welfare Council and Christian Family Service Centre CFSC in Hong Kong The proposed sample size is 858 participants which is a convenience sample from the service user of the Jockey Club E-Generation Impact Extension Project for Chronic Knee Pain Management At least 15 participants will be invited for qualitative interview
Participants will be randomized to the intervention group or the waitlist attention control group in 11 ratio using block randomization with random block size of 4 6 and 8 stratified by each centre and severity of condition A researcher independent to the project will generate the randomization sequence by computer and keep the list Participants in the intervention group known as Group A to the participants will start the 12-week intervention immediately whereas the waitlist attention control know as Group B to the participants will start the intervention after 12 weeks During the waiting period waitlist control receives attention control
Measurements
The primary outcome of this study is quality of life It will be measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale WHOQOL-BREF
The secondary outcomes are pain physical functioning emotional functioning adherence rate satisfaction score rate of adverse events in relation to the intervention and cost-effectiveness of the intervention
Expected results
The improvement in health-related quality of life of older adults is larger in the intervention group as compared to the control group The relief in knee pain of older adults is larger in the intervention group as compared to the control group The improvement in physical functioning of older adults is larger in the intervention group as compared to the control group The improvement in emotional functioning of older adults is larger in the intervention group as compared to the control group
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