The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty

Knee Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346822
• Other study ID #: KMUHIRB-E(I)-20190255
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: July 31, 2021

Study information

• Verified date: April 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Knee Arthritis

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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