The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthritis
• Intervention / Treatment: Procedure: integrated rehabilitation (the collaborative patient education)

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Kaohsiung Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: integrated rehabilitation program for total knee arthroplasty; the intervention was performed in one KMUH affiliated facility	Procedure: integrated rehabilitation (the collaborative patient education); Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty
No Intervention: normal total knee arthroplasty clinical pathway; 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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: April 14, 2022
• First Submitted That Met QC Criteria: April 20, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: total knee arthroplasty; personalized medicine; integrated rehabilitation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: KMUHIRB-E(I)-20190255

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing of the individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No