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

Обзор

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.

Вмешательства

• Другое 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 m
• Другое 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.

Первичные конечные точки

• Change from baseline quality of life at 12 weeks. [Срок оценки: 12 weeks after baseline.]

Вторичные конечные точки (12)

• Change from baseline quality of life at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline pain at 12 weeks. [Срок оценки: 12 weeks after baseline.]
• Change from baseline pain at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline physical functioning, Five Times Sit-to-Stand Test at 12 weeks. [Срок оценки: 12 weeks after baseline.]
• Change from baseline physical functioning, Five Times Sit-to-Stand Test at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline physical functioning, 2-minute Step Test at 12 weeks. [Срок оценки: 12 weeks after baseline.]
• Change from baseline physical functioning, 2-minute Step Test at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 12 weeks. [Срок оценки: 12 weeks after baseline.]
• Change from baseline emotional functioning, Self-Efficacy to Manage Chronic Disease at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline emotional functioning, Cognitive Symptom Management at 12 weeks. [Срок оценки: 12 weeks after baseline.]
• Change from baseline emotional functioning, Cognitive Symptom Management at 24 weeks. [Срок оценки: 24 weeks after baseline, only for waitlist control group.]
• Change from baseline emotional functioning, Sleep Quality at 12 weeks. [Срок оценки: 12 weeks after baseline.]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• Elderly community centre — Гонконг

Идентификаторы

NCT: NCT06569836 · AR230018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗