The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

Study Overview
=================
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.

Official Title
-----------------
The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement

Conditions
-----------------
Knee Arthritis

Intervention / Treatment
-----------------
* Procedure: integrated rehabilitation (the collaborative patient education)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: integrated rehabilitation program for total knee arthroplasty<br>the intervention was performed in one KMUH affiliated facility | Procedure: integrated rehabilitation (the collaborative patient education)<br>* Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty<br>|
| No Intervention: normal total knee arthroplasty clinical pathway<br>no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Pain Score (VAS) | Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity. | From admission to 3 months after surgery | 
| 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. | From admission to 3 months after surgery | 
| 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. | From admission to 3 months after surgery | 
| 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. | From admission to 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
integrated rehabilitation, total knee arthroplasty, personalized medicine