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

NCT06569836 | Recruiting

• 1 other identifier: AR230018
• Study Type: interventional
• Target: 858
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Discomfort; Knee Pain Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• 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 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 physical functioning, Five Times Sit-to-Stand Test at 24 weeks.

  24 weeks after baseline, only for waitlist control group.

Study Arms (2)

Assigned intervention

OTHER

The intervention group will start the 12-week intervention immediately

Other: 12-week intervention

Assigned waitlist control

OTHER

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; Other: 12-week attention control

Interventions

12-week intervention OTHER

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 intervention; Assigned waitlist control

12-week attention control OTHER

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.

Assigned waitlist control

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Hong Kong Sheng Kung Hui Welfare Council Limited: collaborator

Study Sites (1)

Elderly community centre

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Pui Hing Chau, PhD

  School of Nursing, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pui Hing Chau, PhD

CONTACT

3917 6626; phpchau@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 26, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)