Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
NCT ID: NCT06569836
Last Updated: 2024-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
858 participants
INTERVENTIONAL
2024-08-19
2026-09-30
Brief Summary
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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 1:1 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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Assigned intervention
The intervention group will start the 12-week intervention immediately
12-week intervention
Rehabilitation Exercise Plan Week 1-4 For No Symptom Group: Therapeutic home exercise prescription(2 sessions, 60 minutes per session) For Mild \& Moderate Group: Rehabilitation Plan provided by Physiotherapist (4 sessions, 60 minutes per session)
Enhancement of Self-Management Capacity Week 5-8 For No Symptom Group: Educational Workshops provided by Physiotherapist (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Self-management group provided by Social Worker (4 sessions, 60 minutes per session)
Exercise Maintenance Week 9-12 For No Symptom Group: Mobilized Intervention (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Exercise Maintenance provided by Exercise Mentor (4 sessions, 60 minutes per session)
Assigned waitlist control
The waitlist control group will have weekly educational and virtual workshops for 12 weeks.
After 12 weeks assessment, the control group will receive the same intervention as the intervention group for 12 weeks.
12-week intervention
Rehabilitation Exercise Plan Week 1-4 For No Symptom Group: Therapeutic home exercise prescription(2 sessions, 60 minutes per session) For Mild \& Moderate Group: Rehabilitation Plan provided by Physiotherapist (4 sessions, 60 minutes per session)
Enhancement of Self-Management Capacity Week 5-8 For No Symptom Group: Educational Workshops provided by Physiotherapist (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Self-management group provided by Social Worker (4 sessions, 60 minutes per session)
Exercise Maintenance Week 9-12 For No Symptom Group: Mobilized Intervention (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Exercise Maintenance provided by Exercise Mentor (4 sessions, 60 minutes per session)
12-week attention control
The attention and waitlist control group will have weekly educational and virtual workshops for 12 weeks. Three topics will be covered, including online exercise class, cognitive training, leisure and recreational activities. Each session will be 30-45 minutes and each topic last for four weeks. Participants could access the virtual sessions by their electronic devices.
Interventions
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12-week intervention
Rehabilitation Exercise Plan Week 1-4 For No Symptom Group: Therapeutic home exercise prescription(2 sessions, 60 minutes per session) For Mild \& Moderate Group: Rehabilitation Plan provided by Physiotherapist (4 sessions, 60 minutes per session)
Enhancement of Self-Management Capacity Week 5-8 For No Symptom Group: Educational Workshops provided by Physiotherapist (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Self-management group provided by Social Worker (4 sessions, 60 minutes per session)
Exercise Maintenance Week 9-12 For No Symptom Group: Mobilized Intervention (2 sessions, 60 minutes per session) For Mild \& Moderate Group: Exercise Maintenance provided by Exercise Mentor (4 sessions, 60 minutes per session)
12-week attention control
The attention and waitlist control group will have weekly educational and virtual workshops for 12 weeks. Three topics will be covered, including online exercise class, cognitive training, leisure and recreational activities. Each session will be 30-45 minutes and each topic last for four weeks. Participants could access the virtual sessions by their electronic devices.
Eligibility Criteria
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Inclusion Criteria
ii. Community-dwelling;
iii. With self-reported knee pain problem currently or in the past 12 months;
iv. Cognitively sound (screened by the Clock Drawing Test (CDT) ≤ 4 (Agrell \& Dehlin, 1998));
v. Able to understand and communicate in Cantonese or Mandarin.
Exclusion Criteria
ii. Users/ of Hospital Authority medical consultation or physiotherapy or occupational therapy services related to osteoarthritis knee;
iii. Screened to have three or above conditions including significant knee symptom score 5 or above, WOMAC Score ≥48, 5 times Sit to Stand test \>16.7 seconds, Time Up and Go Test \>14 seconds, Age \>80 and BMI \>25.
55 Years
ALL
Yes
Sponsors
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Hong Kong Sheng Kung Hui Welfare Council Limited
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Dr. Pui-Hing Chau
Associate Professor
Principal Investigators
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Pui Hing Chau, PhD
Role: PRINCIPAL_INVESTIGATOR
School of Nursing, The University of Hong Kong
Locations
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Elderly community centre
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Pui Hing Chau
Role: primary
Other Identifiers
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AR230018
Identifier Type: -
Identifier Source: org_study_id