Preoperative Rehabilitation and Education Program

NCT05965986 | Unknown

• 1 other identifier: 120163
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Arthritis; Patient Education; Prehabilitation; Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• 5-level EQ-5D version

  12 months

• Simple Shoulder Test

  12 months

• Single Assessment Numeric Evaluation

  12 months

• Range of motion

  12 months

• Surgical Satisfaction Questionnaire

  3 months

Study Arms (3)

Standard of Care Group

NO INTERVENTION

A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.

Online only

EXPERIMENTAL

a group consisting of an online pre-rehabilitation program 6 weeks before surgery

Other: Experimental: PREPS only

Online and PT

EXPERIMENTAL

a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist

Other: Experimental: PREPS and therapy

Interventions

Experimental: PREPS only OTHER

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.

Online only

Experimental: PREPS and therapy OTHER

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.

Online and PT

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Roth | McFarlane Hand and Upper Limb Center

London, Ontario, N6A4L6, Canada

Location

Related Publications (1)

• Furtado R, MacDermid JC, Bryant D, Faber KJ. Preoperative rehabilitation and education program for surgery (PREPS): A pilot randomized control trial protocol. Hand Ther. 2025 Jun 20;30(4):200-207. doi: 10.1177/17589983251345393. eCollection 2025 Dec.

  PMID: 40547196 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Joy MacDermid, PhD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joy MacDermid, PhD

CONTACT

5196466100; jmacderm@uwo.ca

Katrina Munro

CONTACT

5196466100; katrina.munro@sjhc.london.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 28, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)