Clinical Trials Directory

Trials / Unknown

UnknownNCT05965986

Preoperative Rehabilitation and Education Program

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
90 (estimated)
Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERExperimental: PREPS onlyParticipants 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.
OTHERExperimental: PREPS and therapyParticipants 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.

Timeline

Start date
2023-09-01
Primary completion
2024-09-01
Completion
2025-09-01
First posted
2023-07-28
Last updated
2023-07-28

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05965986. Inclusion in this directory is not an endorsement.