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Preoperative Rehabilitation and Education Program (PREPS)

Primary Purpose

Shoulder Arthritis, Patient Education, Prehabilitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Experimental: PREPS only
Experimental: PREPS and therapy
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Shoulder Arthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roth | McFarlane Hand and Upper Limb Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care Group

Online only

Online and PT

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

5-level EQ-5D version
General Health Status
Simple Shoulder Test
functional outcome measure
Single Assessment Numeric Evaluation
functional outcome measure
Range of motion
shoulder movement
Surgical Satisfaction Questionnaire
satisfaction with surgery
Decisional Regret
decisional conflict with surgery or the preparation
Adherence to rehabilitation
adherence to a post-surgery rehabilitation program
PASS
Single item to understand people's satisfaction with their current health condition
Shoulder Pain and Disability Index
shoulder pain and function for shoulder conditions

Full Information

First Posted
July 7, 2023
Last Updated
July 20, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Western University, Canada, Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05965986
Brief Title
Preoperative Rehabilitation and Education Program
Acronym
PREPS
Official Title
Preoperative Patient Education and Rehabilitation Program for a Total Shoulder Arthroplasty Surgery: a Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Western University, Canada, Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Arthritis, Patient Education, Prehabilitation, Shoulder Arthroplasty

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Online only
Arm Type
Experimental
Arm Description
a group consisting of an online pre-rehabilitation program 6 weeks before surgery
Arm Title
Online and PT
Arm Type
Experimental
Arm Description
a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist
Intervention Type
Other
Intervention Name(s)
Experimental: PREPS only
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Experimental: PREPS and therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recruitment Rate log
Description
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.
Time Frame
6 months
Title
Adherence Rate log
Description
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.
Time Frame
6 months
Title
Content Acceptability - visual analog scale
Description
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.
Time Frame
12 months
Title
Study Acceptability - visual analog scale
Description
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.
Time Frame
12 months
Title
Treatment Fidelity checklist
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
5-level EQ-5D version
Description
General Health Status
Time Frame
12 months
Title
Simple Shoulder Test
Description
functional outcome measure
Time Frame
12 months
Title
Single Assessment Numeric Evaluation
Description
functional outcome measure
Time Frame
12 months
Title
Range of motion
Description
shoulder movement
Time Frame
12 months
Title
Surgical Satisfaction Questionnaire
Description
satisfaction with surgery
Time Frame
3 months
Title
Decisional Regret
Description
decisional conflict with surgery or the preparation
Time Frame
3 months
Title
Adherence to rehabilitation
Description
adherence to a post-surgery rehabilitation program
Time Frame
12 months
Title
PASS
Description
Single item to understand people's satisfaction with their current health condition
Time Frame
12 months
Title
Shoulder Pain and Disability Index
Description
shoulder pain and function for shoulder conditions
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joy MacDermid, PhD
Phone
5196466100
Ext
64636
Email
jmacderm@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Munro
Phone
5196466100
Ext
64640
Email
katrina.munro@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roth | McFarlane Hand and Upper Limb Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joy MacDermid, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Preoperative Rehabilitation and Education Program

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