Clinical trial NCT06569836: Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
Official title: Evaluation Study for the "Jockey Club E-Generation: Impact Extension Project for Chronic Knee Pain Management"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Discomfort
Knee Pain Chronic
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Sheng Kung Hui Welfare Council Limited
First posted: 2024-08-26
Enrollment: 858
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline quality of life at 12 weeks.
timeFrame: 12 weeks after baseline.
Secondary outcomes:
measure: Change from baseline quality of life at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline pain at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline pain at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline physical functioning, Five Times Sit-to-Stand Test at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline physical functioning, 2-minute Step Test at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline physical functioning, 2-minute Step Test at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline emotional functioning, Sleep Quality at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline emotional functioning, Sleep Quality at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline emotional functioning, depression at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline emotional functioning, depression at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Change from baseline emotional functioning, quality of life at 12 weeks.
timeFrame: 12 weeks after baseline.
measure: Change from baseline emotional functioning, quality of life at 24 weeks.
timeFrame: 24 weeks after baseline, only for waitlist control group.
measure: Adherence rate
timeFrame: During 12 weeks intervention
measure: Satisfaction score
timeFrame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
measure: Rate of adverse events in relation to the intervention
timeFrame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
measure: Cost-effectiveness of the intervention
timeFrame: 12 weeks after baseline for intervention group, 24 weeks after baseline for waitlist control group.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Elderly community centre
Study officials:
affiliation: School of Nursing, The University of Hong Kong
name: Pui Hing Chau, PhD
role: PRINCIPAL_INVESTIGATOR
References: