Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients
Primary Purpose
Knee Osteoarthritis, Pain, Self Efficacy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transitional care model
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Having decided to undergo total knee arthroplasty for the first time due to osteoarthritis
- Volunteering to participate in the research, not having a psychological, physical, and mental disability that may prevent communication, not having any major chronic problems such as end-stage organ failure, kidney, neurological, cancer
- Being discharged to the home from a hospital
- Being able to speak Turkish
- Being available by phone
- Being aged 50 and over
Exclusion Criteria:
- Unwillingness to continue the study
- Rehospitalization
- Exposure to a disease or trauma that would affect functional independence during the study
Sites / Locations
- Mustafa Kemal Üniversitesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transitional care
Usual care
Arm Description
This group is the actual intervention group.
This group is the routine treatment (control) valid in the clinical practice.
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC
Assessments of functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Arthritis Self-efficacy Scale (ASES)
Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Secondary Outcome Measures
number of hospital visits
Assessments of the number of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge.
Full Information
NCT ID
NCT05525793
First Posted
August 25, 2022
Last Updated
August 30, 2022
Sponsor
Hasan Kalyoncu University
1. Study Identification
Unique Protocol Identification Number
NCT05525793
Brief Title
Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients
Official Title
Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2021 (Actual)
Primary Completion Date
August 8, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasan Kalyoncu University
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
The aim of this study was to determine the effectiveness of transitional care in patients with total knee arthroplasty on patients' functional status, perceived self-efficacy, and health care use. Based on the sampling inclusion criteria, we assigned the patients who would undergo knee arthroplasty to the control (n=35) and intervention (n=35) groups, via the block randomization method. The intervention group received transitional care, while the control group received usual care. Data were collected on post-intervention functional status, level of self-efficacy, and hospital visits outside of routine control.
Detailed Description
This randomised control study was conducted 70 eligible partients with total knee arthroplasty in a public hospital orthopedic and traumatology service. Participants were randomly assigned to receive either the 6-week 'Transitional Care Model' program or usual care. Assessments of self-efficacy and functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge. Time-dependent changes in patient outcomes were assessed by using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Arthritis Self-efficacy Scale (ASES) measurements tools. Assessments of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge. The functional status of the intervention group patients improved more than the control group according to WOMAC mean scores. Intervention group patients receiving transitional care had higher mean scores at the 2nd-week and 9th-week postoperatively in perceived self-efficacy . Besides, the rate of admission to the hospital in the intervention group was lower compared to the control group, and a significant difference was observed in the 6th-week follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Pain, Self Efficacy, Health Care Utilization
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transitional care
Arm Type
Experimental
Arm Description
This group is the actual intervention group.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
This group is the routine treatment (control) valid in the clinical practice.
Intervention Type
Other
Intervention Name(s)
Transitional care model
Intervention Description
The patients who were assigned to this group with the transitional care model, 6 weeks of counseling and intervention training provided continuity of care and a safe transition, and patients were encouraged about symptom management and a healthy lifestyle.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC
Description
Assessments of functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Time Frame
up to 9 weeks
Title
Arthritis Self-efficacy Scale (ASES)
Description
Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Time Frame
up to 9 weeks
Secondary Outcome Measure Information:
Title
number of hospital visits
Description
Assessments of the number of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge.
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having decided to undergo total knee arthroplasty for the first time due to osteoarthritis
Volunteering to participate in the research, not having a psychological, physical, and mental disability that may prevent communication, not having any major chronic problems such as end-stage organ failure, kidney, neurological, cancer
Being discharged to the home from a hospital
Being able to speak Turkish
Being available by phone
Being aged 50 and over
Exclusion Criteria:
Unwillingness to continue the study
Rehospitalization
Exposure to a disease or trauma that would affect functional independence during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betül Tosun, Assoc. Prof.
Organizational Affiliation
Hasan Kalyoncu Üniversitesi
Official's Role
Study Chair
Facility Information:
Facility Name
Mustafa Kemal Üniversitesi
City
Antakya
State/Province
Hatay
ZIP/Postal Code
31060
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33074309
Citation
An S, Li J, Xie W, Yin N, Li Y, Hu Y. Extracorporeal shockwave treatment in knee osteoarthritis: therapeutic effects and possible mechanism. Biosci Rep. 2020 Nov 27;40(11):BSR20200926. doi: 10.1042/BSR20200926.
Results Reference
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PubMed Identifier
28870302
Citation
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Results Reference
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PubMed Identifier
32950214
Citation
Magan AA, Ahmed SS, Paton B, Konan S, Haddad FS. Does Multimodal Therapy Influence Functional Outcome After Total Knee Arthroplasty? Orthop Clin North Am. 2020 Oct;51(4):453-459. doi: 10.1016/j.ocl.2020.06.011.
Results Reference
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PubMed Identifier
24493186
Citation
Hanusch BC, O'Connor DB, Ions P, Scott A, Gregg PJ. Effects of psychological distress and perceptions of illness on recovery from total knee replacement. Bone Joint J. 2014 Feb;96-B(2):210-6. doi: 10.1302/0301-620X.96B2.31136.
Results Reference
background
PubMed Identifier
33154651
Citation
Mardani A, Griffiths P, Vaismoradi M. The Role of the Nurse in the Management of Medicines During Transitional Care: A Systematic Review. J Multidiscip Healthc. 2020 Oct 30;13:1347-1361. doi: 10.2147/JMDH.S276061. eCollection 2020.
Results Reference
background
PubMed Identifier
32322183
Citation
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Results Reference
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PubMed Identifier
32917145
Citation
Morkisch N, Upegui-Arango LD, Cardona MI, van den Heuvel D, Rimmele M, Sieber CC, Freiberger E. Components of the transitional care model (TCM) to reduce readmission in geriatric patients: a systematic review. BMC Geriatr. 2020 Sep 11;20(1):345. doi: 10.1186/s12877-020-01747-w.
Results Reference
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PubMed Identifier
25485791
Citation
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Results Reference
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PubMed Identifier
33146267
Citation
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Results Reference
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PubMed Identifier
33901941
Citation
Lyu QY, Huang JW, Li YX, Chen QL, Yu XX, Wang JL, Yang QH. Effects of a nurse led web-based transitional care program on the glycemic control and quality of life post hospital discharge in patients with type 2 diabetes: A randomized controlled trial. Int J Nurs Stud. 2021 Jul;119:103929. doi: 10.1016/j.ijnurstu.2021.103929. Epub 2021 Mar 26.
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Citation
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Citation
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Citation
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Results Reference
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Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients
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