Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- The University of Hong Kong
- Enrollment
- 858
- Locations
- 1
- Primary Endpoint
- Change from baseline quality of life at 12 weeks.
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •i. Aged ≥55 years;
- •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
- •i. Diagnosed with stroke, myocardial infarction, injury or inflammation of the knee, autoimmune disease, unable to walk in the past three months;
- •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.
Arms & Interventions
Assigned intervention
The intervention group will start the 12-week intervention immediately
Intervention: 12-week intervention (Other)
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.
Intervention: 12-week intervention (Other)
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.
Intervention: 12-week attention control (Other)
Outcomes
Primary Outcomes
Change from baseline quality of life at 12 weeks.
Time Frame: 12 weeks after baseline.
Measured by the Hong Kong Chinese version of World Health Organization Quality-of-Life Scale (WHOQOL-BREF). Scoring based on a rule set by the World Health Organization and converted to a score between 4 and 20 for all domains, with the higher the score, the better the quality of life.
Secondary Outcomes
- Change from baseline physical functioning, 2-minute Step Test at 12 weeks.(12 weeks after baseline.)
- Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks.(12 weeks after baseline.)
- Change from baseline physical functioning, 2-minute Step Test at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline emotional functioning, quality of life at 12 weeks.(12 weeks after baseline.)
- Change from baseline emotional functioning, quality of life at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline quality of life at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline pain at 12 weeks.(12 weeks after baseline.)
- Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline emotional functioning, Sleep Quality at 12 weeks.(12 weeks after baseline.)
- Change from baseline emotional functioning, Sleep Quality at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline pain at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline physical functioning, Five Times Sit-to-Stand Test at 12 weeks.(12 weeks after baseline.)
- Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 12 weeks.(12 weeks after baseline.)
- Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Change from baseline emotional functioning, depression at 24 weeks.(24 weeks after baseline, only for waitlist control group.)
- Adherence rate(During 12 weeks intervention)
- Satisfaction score(12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.)
- Change from baseline emotional functioning, depression at 12 weeks.(12 weeks after baseline.)
- Rate of adverse events in relation to the intervention(12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.)
- Cost-effectiveness of the intervention(12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.)
Investigators
Dr. Pui-Hing Chau
Associate Professor
The University of Hong Kong