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
- 1
- 主要终点
- Adverse events
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)
研究组 & 干预措施
Health coaching
Participants randomized to the intervention group will receive access to the Active Wait program, which includes remote, self-paced (asynchronous) education, exercise, and nutritional advice delivered via a web-based platform. The participants in the intervention group will have access to the program, in conjunction with health coaching.
Patients undertaking health coaching will be assigned a personal health coach who will provide support to increase their ability to self-manage through self- regulation principles of behaviour change. Health coaching sessions will be delivered remotely (via telephone or video conferencing) a maximum of 8-times during a 12-week intervention period. Sessions are limited to 1 hour, offering education, self-management strategies, barrier and facilitator identification, support and encouragement, goal setting, action planning and self-monitoring with the intention to facilitate positive and sustainable lifestyle and behaviour changes.
干预措施: Health coaching (Behavioral)
Digital toolkit
Patients in the active-comparator group will be given a link to the same Digital Toolkit. The digital toolkit is a 12-week non-contact programme titled Active Wait, which offers education, self-management techniques and an unsupervised strength programme. The website Active Wait can be accessed via the link: https://protect-au.mimecast.com/s/8_5gCP7yRZiWn3q3FzwqnS?domain=sheffieldachesandpains.com/
干预措施: Digital toolkit (Behavioral)
结局指标
主要结局
Adverse events
时间窗: 12 weeks
Bowens Framework- practicality, measured by number, type and severity of adverse events
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
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)