Preoperative Rehabilitation and Education Program

Prehabilitation Clinical Trial

— PREPS  

Official title:

Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05965986
• Other study ID #: 120163
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: July 2023
• Source: Lawson Health Research Institute
• Contact: Joy MacDermid, PhD
• Phone: 5196466100
• Email: jmacderm[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients who have consented for a hemi-arthroplasty surgery
• Patients who have been consented less than 8 weeks before surgery
• Any contraindications to exercise

Related Conditions & MeSH terms

• Arthritis
• Patient Education
• Prehabilitation
• Shoulder Arthritis
• Shoulder Arthroplasty

Intervention

Other:
• Experimental: PREPS only
Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification. The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative.
• Experimental: PREPS and therapy
Participants will be guided through an education program and exercise program that will cover topics. Participants will have flexibility as to when and how often then need to review material. Participants will be directed to completed on-screen interactive quizzes to re-enforce learning. Participants are encouraged to pose any questions regarding the material they are learning within the education modules to the research team for further clarification. The intervention group will be asked to participate in the program (6 weeks), but after their surgery, they will not be asked to continue the education or exercise program. However, they will be tracking their activity and adherence to physical therapy through a log for one year post-operative. In addition, participants will have a therapist call on week 2 and 4 of the program and then one week after surgery to check in and ensure the patient is meeting all milestones and answer any questions.

Locations

Country	Name	City	State
Canada	Roth | McFarlane Hand and Upper Limb Center	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Institutes of Health Research (CIHR), Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate log	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.	6 months
Primary	Adherence Rate log	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.	6 months
Primary	Content Acceptability - visual analog scale	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.	12 months
Primary	Study Acceptability - visual analog scale	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.	12 months
Primary	Treatment Fidelity checklist	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.	12 months
Secondary	5-level EQ-5D version	General Health Status	12 months
Secondary	Simple Shoulder Test	functional outcome measure	12 months
Secondary	Single Assessment Numeric Evaluation	functional outcome measure	12 months
Secondary	Range of motion	shoulder movement	12 months
Secondary	Surgical Satisfaction Questionnaire	satisfaction with surgery	3 months
Secondary	Decisional Regret	decisional conflict with surgery or the preparation	3 months
Secondary	Adherence to rehabilitation	adherence to a post-surgery rehabilitation program	12 months
Secondary	PASS	Single item to understand people's satisfaction with their current health condition	12 months
Secondary	Shoulder Pain and Disability Index	shoulder pain and function for shoulder conditions	12 months