Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients

August 30, 2022 updated by: Ayla Güllü, Hasan Kalyoncu University

Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Hatay
      • Antakya, Hatay, Turkey, 31060
        • Mustafa Kemal Universitesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transitional care
This group is the actual intervention group.
Other: Transitional care model
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.
No Intervention: Usual care
This group is the routine treatment (control) valid in the clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC
Time Frame: up to 9 weeks
Assessments of functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge.
up to 9 weeks
Arthritis Self-efficacy Scale (ASES)
Time Frame: up to 9 weeks
Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.
up to 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of hospital visits
Time Frame: up to 12 weeks
Assessments of the number of hospital visits outside of routine control were conducted 2nd week, 6th week, 9th week, and 12th weeks after discharge.
up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Kalyoncu University

Investigators

  • Study Chair: Betül Tosun, Assoc. Prof., Hasan Kalyoncu Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

August 8, 2021

Study Completion (Actual)

November 11, 2021

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 30, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hasan Kalyoncu Üniversitesi
  • 2021/004 (Other Identifier: Scientific Research Ethical Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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