Health Coaching in Addition to a Digital Resource to Promote Self-management for Patients Waiting for Total Hip or Knee Replacements: A Randomised Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Global rating of change
研究概览
简要总结
This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
- •have access to the internet and the ability to navigate web-based programs;
- •able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
- •able to comprehend the requirements and purpose of the study and give informed consent
排除标准
- •other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
- •neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
- •systemic inflammatory disease (e.g. rheumatoid arthritis);
- •previous total joint replacement surgery (hip or knee)
结局指标
主要结局
Global rating of change
时间窗: 12 weeks
Bowens Framework - acceptability (Perceived benefits) 7-point likert scale global rating of change (GROC) with -3 being worse, 0 being no change and 3 being better
Perceived Satisfaction
时间窗: 12 weeks
Bowens Framework - acceptability (Perceived satisfaction). How satisfied were you with the overall information, level of support, and ease of use of the program? Measured on a numeric rating scale, where 0 means not satisfied, 10 means significant satisfaction.
Rate of retention
时间窗: 12 weeks
Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments
Drop out rate
时间窗: 12 weeks
Bowens Framework - acceptability, percentage of people discontinuing in both groups
Adverse events
时间窗: 12 weeks
Bowens Framework- practicality, measured by number, type and severity of adverse events
Rate of service utilisation
时间窗: 12 weeks
Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website
Rates of recruitment
时间窗: 12 weeks
Bowens Framework - demand, measured by n number of recruitment per week.
次要结局
- Demographics(12 weeks)
- Arthritis Self-Efficacy Scale (ASES-8)(12 weeks)
- International physical activity questionnaire-short form (IPAQ-SF)(12 weeks)
- EuroQoL Group's 5-dimension (EQ-5D-5L)(12 week)
- Visual Analogue Scale(12 week)
- Oxford knee/hip score(12 week)
- Knee flexion/extension strength(12 week)
- 4 x 10m walk test(12 week)
- 12 steps test(12 week)
- Time up and go(12 week)
- Sit to stand test(12 week)
- Minutes in sedentary activities(1 week baseline and 1 week at completion)