The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
Primary Purpose
Knee Arthritis
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
integrated rehabilitation (the collaborative patient education)
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Arthritis focused on measuring integrated rehabilitation, total knee arthroplasty, personalized medicine
Eligibility Criteria
Inclusion Criteria
- Patients over 65 years of age
- Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
- Patients are able to understand the study and express opinions clearly
- Patients are willing to participate in this study and provide informed consents
Exclusion Criteria
- Patients with inflammatory joint disease
- Patients with neurosensory system disease (such as stroke or parkinsonism)
- Patients have intellectual impairment, or dementia.
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
integrated rehabilitation program for total knee arthroplasty
normal total knee arthroplasty clinical pathway
Arm Description
the intervention was performed in one KMUH affiliated facility
no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway
Outcomes
Primary Outcome Measures
Visual Analogue Pain Score (VAS)
Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.
State-trait Anxiety Inventory (STAI)
Peri-operative anxiety scoring system. STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Higher scores mean higher anxiety.
American Knee Society Scores(AKS)
The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score). Higher scores mean a better outcome.
WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)
The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68). Higher scores mean worse outcomes.
Secondary Outcome Measures
Full Information
NCT ID
NCT05346822
First Posted
April 14, 2022
Last Updated
April 20, 2022
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05346822
Brief Title
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
Official Title
The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
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
This project is about the integrated rehabilitation program for the patients receiving total knee arthroplasty. The investigators are monitoring the WOMAC(Western Ontario and Mcmaster University Arthritis Index)/ Pain scores/Anxiety scores/Knee society scores in the treatment course between the intervention group and the control group.
Detailed Description
This is a quasi-experimental design study. The participants received total knee arthroplasty by one single surgeon in two facilities within the same medical system (Kaohsiung Medical University affiliated hospitals). The intervention groups received integrated rehabilitation program including verbal one-on-one education, personalized post-operation rehabilitation during admission and scheduled post-operation follow up by a nurse case manager. The control group received the same surgery with traditional clinical pathway by the single surgeon in another affiliated hospital.
We recorded the pain scores, state-trait anxiety inventory scores, WOMAC(Western Ontario and Mcmaster Universities Arthritis Index) scores, American Knee society scores for these participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthritis
Keywords
integrated rehabilitation, total knee arthroplasty, personalized medicine
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
integrated rehabilitation program for total knee arthroplasty
Arm Type
Experimental
Arm Description
the intervention was performed in one KMUH affiliated facility
Arm Title
normal total knee arthroplasty clinical pathway
Arm Type
No Intervention
Arm Description
no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway
Intervention Type
Procedure
Intervention Name(s)
integrated rehabilitation (the collaborative patient education)
Intervention Description
Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty
Primary Outcome Measure Information:
Title
Visual Analogue Pain Score (VAS)
Description
Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.
Time Frame
From admission to 3 months after surgery
Title
State-trait Anxiety Inventory (STAI)
Description
Peri-operative anxiety scoring system. STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80). Higher scores mean higher anxiety.
Time Frame
From admission to 3 months after surgery
Title
American Knee Society Scores(AKS)
Description
The AKS ranges from 100 (normal knee function score) to 0 (worst knee function score). Higher scores mean a better outcome.
Time Frame
From admission to 3 months after surgery
Title
WOMAC (Western Ontario and Mcmaster Universities Arthritis Index)
Description
The WOMAC evaluates 3 dimensions : pain(maximal score of 20), stiffness(maximal score of 8), and physical function(maximal score of 68). Higher scores mean worse outcomes.
Time Frame
From admission to 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Patients over 65 years of age
Patients scheduled to receive unilateral total knee arthroplasty due to advanced osteoarthritis
Patients are able to understand the study and express opinions clearly
Patients are willing to participate in this study and provide informed consents
Exclusion Criteria
Patients with inflammatory joint disease
Patients with neurosensory system disease (such as stroke or parkinsonism)
Patients have intellectual impairment, or dementia.
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No sharing of the individual participant data
Learn more about this trial
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
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