Knee ArthritisNCT05346822
The Efficacy of Collaborative Patient Education on Total Knee Arthroplasty
A study testing integrated rehabilitation (the collaborative patient education) in people with Knee Arthritis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- integrated rehabilitation (the collaborative patient education)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2019to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Patients with inflammatory joint disease
- Patients with neurosensory system disease (such as stroke or parkinsonism)
- Patients have intellectual impairment, or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Arthritis
- Being tested
- integrated rehabilitation (the collaborative patient education)
- Keywords
- integrated rehabilitation, total knee arthroplasty, personalized medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated rehabilitation (the collaborative patient education)Procedure or surgery
Pre-operative education and rehabilitation. During hospitalization: group rehabilitation education program. Discharge: post-operative care navigation for total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| integrated rehabilitation program for total knee arthroplasty | Experimental | the intervention was performed in one KMUH affiliated facility Receives: Procedure: integrated rehabilitation (the collaborative patient education) |
| normal total knee arthroplasty clinical pathway | No intervention | no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Pain Score (VAS)
Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From admission to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start17 Sep 2019
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346822
- Sponsor's protocol ID
- KMUHIRB-E(I)-20190255
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing of the individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Patient-specific Integrated Education Program on Pain, Perioperative Anxiety, and Functional Recovery Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05346822
- Acronym / sponsor ID
- KMUHIRB-E(I)-20190255
- Conditions
- Knee Arthritis
- Keywords
- integrated rehabilitation, total knee arthroplasty, personalized medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-site, two-arm, parallel-group controlled trial of integrated rehabilitation program
| Arm | Type | Receives |
|---|---|---|
| integrated rehabilitation program for total knee arthroplasty | Experimental | Procedure: integrated rehabilitation (the collaborative patient education)the intervention was performed in one KMUH affiliated facility |
| normal total knee arthroplasty clinical pathway | No intervention | –no integrated rehabilitatoin program for total knee arthroplasty patients with our conventional clinical pathway |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with inflammatory joint disease
- Patients with neurosensory system disease (such as stroke or parkinsonism)
- Patients have intellectual impairment, or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | integrated rehabilitation program for total knee arthroplasty |
Primary outcome
Visual Analogue Pain Score (VAS)
Time frame: From admission to 3 months after surgery
Minimum pain intensity from 0 to Maximum of 10. Higher scores mean a higher pain intensity.
State-trait Anxiety Inventory (STAI)
Time frame: From admission to 3 months after surgery
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)
Time frame: From admission to 3 months after surgery
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)
Time frame: From admission to 3 months after surgery
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No. No sharing of the individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated rehabilitation (the collaborative patient education) in people with Knee Arthritis, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Pain Score (VAS) (time frame: From admission to 3 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.