Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"

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 Overview

• Status: Recruiting
• Conditions: Knee Discomfort; Knee Pain Chronic
• Intervention / Treatment: Other: 12-week intervention; Other: 12-week attention control

• Study Type: Interventional
• Enrollment (Estimated): 858
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pui Hing Chau, PhD; Phone Number: 3917 6626; Email: phpchau@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Elderly community centre
    • Contact: Pui Hing Chau; Phone Number: 3917 6626; Email: phpchau@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Assigned intervention; The intervention group will start the 12-week intervention immediately	Other: 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)
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.	Other: 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); Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline quality of life at 12 weeks.	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.	12 weeks after baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline quality of life at 24 weeks.	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.	24 weeks after baseline, only for waitlist control group.
Change from baseline pain at 12 weeks.	Measured by the pain subscale of Chinese version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitations.	12 weeks after baseline.
Change from baseline pain at 24 weeks.	Measured by the pain subscale of Chinese version of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitations.	24 weeks after baseline, only for waitlist control group.
Change from baseline physical functioning, Five Times Sit-to-Stand Test at 12 weeks.	Measured by the Five Times Sit-to-Stand Test, scoring the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.	12 weeks after baseline.
Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks.	Measured by the Five Times Sit-to-Stand Test, scoring the amount of time a patient is able to transfer from a seated to a standing position and back to sitting five times. The lower the time to complete the test the better the outcome of the test.	24 weeks after baseline, only for waitlist control group.
Change from baseline physical functioning, 2-minute Step Test at 12 weeks.	Measured by the 2-minute Step Test, scoring how many times the patient's right knee reaches the point that is halfway between the midpoint of the patient's patella and the top of their iliac crest while marching in place for 2 minutes. Higher scores indicate greater levels of aerobic capacity.	12 weeks after baseline.
Change from baseline physical functioning, 2-minute Step Test at 24 weeks.	Measured by the 2-minute Step Test, scoring how many times the patient's right knee reaches the point that is halfway between the midpoint of the patient's patella and the top of their iliac crest while marching in place for 2 minutes. Higher scores indicate greater levels of aerobic capacity.	24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 12 weeks.	Measured by the Self-Efficacy to Manage Chronic Disease Scale, scoring range from 1 to 10, the higher the score, the greater the self-efficacy.	12 weeks after baseline.
Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks.	Measured by the Self-Efficacy to Manage Chronic Disease Scale, scoring range from 1 to 10, the higher the score, the greater the self-efficacy.	24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks.	Measured by the Cognitive Symptom Management (CSM) Scale, scoring range from 0 to 5, with a higher score indicating more practice of these techniques.	12 weeks after baseline.
Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks.	Measured by the Cognitive Symptom Management (CSM) Scale, scoring range from 0 to 5, with a higher score indicating more practice of these techniques.	24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, Sleep Quality at 12 weeks.	Measured by the Pittsburgh Sleep Quality Index (PSQI), scoring range from 0 to 21 with higher score indicating poorer quality.	12 weeks after baseline.
Change from baseline emotional functioning, Sleep Quality at 24 weeks.	Measured by the Pittsburgh Sleep Quality Index (PSQI), scoring range from 0 to 21 with higher score indicating poorer quality.	24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, depression at 12 weeks.	Measured by the Patient Health Questionnaire-9 (PHQ-9), scoring range from 0 to 27, the higher the score, the more severe the depression.	12 weeks after baseline.
Change from baseline emotional functioning, depression at 24 weeks.	Measured by the Patient Health Questionnaire-9 (PHQ-9), scoring range from 0 to 27, the higher the score, the more severe the depression.	24 weeks after baseline, only for waitlist control group.
Change from baseline emotional functioning, quality of life at 12 weeks.	Measured by the 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.	12 weeks after baseline.
Change from baseline emotional functioning, quality of life at 24 weeks.	Measured by the 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.	24 weeks after baseline, only for waitlist control group.
Adherence rate	Collected by a practice record in the App, as well as class attendance record for face-to-face classes	During 12 weeks intervention
Satisfaction score	Assessed by a five-point Likert scale, 0 indicates not satisfied at all, 4 indicates very satisfied. The higher the score, the higher the satisfaction level.	12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Rate of adverse events in relation to the intervention	Symptoms and adverse events will be recorded by a single question.	12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Cost-effectiveness of the intervention	Expenses related to (emergency department visits, outpatient, inpatient, rehabilitation, over-the-counter medication and supplement) related to knee pain or falls will be collected. Costing of the intervention from the service provider will be obtained from the service provider directly.	12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Hong Kong Sheng Kung Hui Welfare Council Limited
• Investigators: Principal Investigator: Pui Hing Chau, PhD, School of Nursing, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Estimated): December 5, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AR230018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No