Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Adherence Rate log
研究概览
简要总结
Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Uncertainties about the surgery and recovery process can further cause post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers offer an in- class program to educate patients before surgery, some patients face issues with distance or transportation, and cannot regularly meet their doctor to address all their concerns. This project aims to create an online educational program that will teach patients through online videos and educational materials before they go into shoulder replacement surgery. By creating online modules, it can increase the accessibility for home use, and prepare patients on topics such as: their concerns about the surgery and proper exercises they can expect after surgery for a safe recovery. The aim is to study three groups of patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6 weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist or 3. A group consisting of the current standard of care, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. Researchers will monitor all groups on their recovery before and after surgery. This will provide another alternative to informing patients before surgery and help them to prepare better for surgery. The online modules will contribute to improving the care in Southern Ontario and eventually be used for future care across Canada.
详细描述
A total shoulder replacement is a common procedure to help those with shoulder osteoarthritis improve their quality of life. There is a lack of quality research on the effectiveness of prehabilitation and education on pain, function, and quality of life in patients undergoing this procedure. Researchers have developed a comprehensive, patient-centered program that combines exercise, preparedness for surgery, motivational interviewing, and pain management principles, in collaboration with patient partners on the wait list for a shoulder replacement, transdisciplinary healthcare team (i.e., surgeons, physiotherapists, occupational therapists, and rehabilitation researchers), and current scientific literature. This patient-centered program has the potential to improve postoperative pain, function, and patient-oriented outcomes, decrease postoperative opioid use and short and long-term healthcare costs. This pilot randomized controlled trial will evaluate feasibility and satisfaction of the program for individuals undergoing a shoulder replacement. Participants (n=90) undergoing a shoulder replacement will be randomized into 1) 6-week online pre-rehab and education program, 2) 6-week online pre-rehab and education program with a therapist or 3) standard of care group. The intervention groups will be delivered virtually with an online program of modules and a written handbook for participants. Participants in the standard of care group will receive usual care. Outcomes will be assessed at baseline and 1 day before surgery, then post-operatively at 6 weeks, 3 months, 6 months and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18 years old
- •Patients who have consented for a total shoulder arthroplasty or reverse shoulder arthroplasty surgery at HULC.
- •Date of surgery must be no shorter than 9 weeks, to ensure time for baseline measures
- •Speaks and reads in English unless can provide a translator
- •Able to provide informed consent.
- •Willing to participate in study procedures for at least 1 year post-surgery.
排除标准
- •Patients who have consented for a hemi-arthroplasty surgery
- •Patients who have been consented less than 8 weeks before surgery
- •Any contraindications to exercise
结局指标
主要结局
Adherence Rate log
时间窗: 6 months
Adherence to the education program will be considered adequate if 80% of all participants in the intervention groups complete the full online program and report it on the log. Exercise programs will be considered adequate if 60% of participants in the intervention groups report exercise at least 3 times per week.
Content Acceptability - visual analog scale
时间窗: 12 months
Content acceptability will be assessed using a visual analog scale (VAS), where acceptability will be considered adequate if 60% of participants found the treatment useful and helpful with a score of 7/10.
Treatment Fidelity checklist
时间窗: 12 months
if 80% of phone calls were documented accurately and able to meet the criteria of the checklist by the therapist, fidelity will be considered acceptable.
Recruitment Rate log
时间窗: 6 months
We will proceed with the larger trial if we are able to recruit 90 participants within 6 months, and if 50% of eligible participants consent to participate.
Study Acceptability - visual analog scale
时间窗: 12 months
Similarly, if 60% of participants found the treatment delivery acceptable, and reported being likely to use this treatment again and recommend it to others with a VAS score of 7/10, the format will be considered acceptable.
次要结局
- Adherence to rehabilitation(12 months)
- Single Assessment Numeric Evaluation(12 months)
- Decisional Regret(3 months)
- Range of motion(12 months)
- Surgical Satisfaction Questionnaire(3 months)
- 5-level EQ-5D version(12 months)
- Simple Shoulder Test(12 months)
- PASS(12 months)
- Shoulder Pain and Disability Index(12 months)
研究者
Joy MacDermid
Professor
Lawson Health Research Institute