Knee OsteoarthritisNCT05525793
Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients
A study testing Transitional care model in people with Knee Osteoarthritis and Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain, Self Efficacy
- What is being tested?
- Transitional care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2021to 11 Nov 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwillingness to continue the study
- Rehospitalization
- Exposure to a disease or trauma that would affect functional independence during the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal Üniversitesi
Antakya, Hatay, 31060
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Pain, Self Efficacy, Health Care Utilization
- Being tested
- Transitional care model
- Medical subject headings
- Osteoarthritis, Knee, Pain, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional care modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transitional care | Experimental | This group is the actual intervention group. Receives: Other: Transitional care model |
| Usual care | No intervention | This group is the routine treatment (control) valid in the clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC
Assessments of functional status of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Measured: up to 9 weeks
Arthritis Self-efficacy Scale (ASES)
Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.
Measured: up to 9 weeks
Secondary outcomes (1)
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.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start8 Feb 2021
- Primary completion8 Aug 2021
- Study completion11 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayla Güllü, Hasan Kalyoncu University
- Investigators
- Betül Tosun, Assoc. Prof., Study chair, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525793
- Sponsor's protocol ID
- Hasan Kalyoncu Üniversitesi
- Other IDs
- 2021/004
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33074309Gaffney CJ, Pelt CE, Gililland JM, Peters CL. Perioperative Pain Management in Hip and Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):407-419. doi: 10.1016/j.ocl.2017.05.001. Epub 2017 Jun 29.
PubMed 28870302Magan 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.
PubMed 32950214Hanusch 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.
PubMed 24493186Mardani 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.
PubMed 33154651Allen J, Hutchinson AM, Brown R, Livingston PM. Communication and Coordination Processes Supporting Integrated Transitional Care: Australian Healthcare Practitioners' Perspectives. Int J Integr Care. 2020 Apr 16;20(2):1. doi: 10.5334/ijic.4685.
PubMed 32322183Morkisch 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.
PubMed 32917145Hung D, Leidig RC. Implementing a transitional care program to reduce hospital readmissions among older adults. J Nurs Care Qual. 2015 Apr-Jun;30(2):121-9. doi: 10.1097/NCQ.0000000000000091.
PubMed 25485791Costa MFBNAD, Sichieri K, Poveda VB, Baptista CMC, Aguado PC. Transitional care from hospital to home for older people: implementation of best practices. Rev Bras Enferm. 2020 Nov 2;73Suppl 3(Suppl 3):e20200187. doi: 10.1590/0034-7167-2020-0187. eCollection 2020. English, Portuguese.
PubMed 33146267Lyu 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.
PubMed 33901941Liu ZC, Gao L, Zhang WH, Wang J, Liu RR, Cao BH. Effects of a 4-week Omaha System transitional care programme on rheumatoid arthritis patients' self-efficacy, health status, and readmission in mainland China: A randomized controlled trial. Int J Nurs Pract. 2020 Aug;26(4):e12817. doi: 10.1111/ijn.12817. Epub 2020 Jan 27.
PubMed 31985129Kranker K, Barterian LM, Sarwar R, Peterson GG, Gilman B, Blue L, Stewart KA, Hoag SD, Day TJ, Moreno L. Rural hospital transitional care program reduces Medicare spending. Am J Manag Care. 2018 May;24(5):256-260.
PubMed 29851443Nall RW, Herndon BB, Mramba LK, Vogel-Anderson K, Hagen MG. An Interprofessional Primary Care-Based Transition of Care Clinic to Reduce Hospital Readmission. Am J Med. 2020 Jun;133(6):e260-e268. doi: 10.1016/j.amjmed.2019.10.040. Epub 2019 Dec 24.
PubMed 31877267Gullu A, Tosun B. Effectiveness of the transitional care model in total knee arthroplasty patients: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13283. doi: 10.1111/ijn.13283. Epub 2024 Jul 11.
PubMed 38989604
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Transitional Care Model in Total Knee Arthroplasty Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05525793
- Acronym / sponsor ID
- Hasan Kalyoncu Üniversitesi
- Conditions
- Knee Osteoarthritis, Pain, Self Efficacy, Health Care Utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 Aug 2021 (actual)
- Study completion
- 11 Nov 2021 (actual)
- First posted
- 2 Sep 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitional care | Experimental | Other: Transitional care modelThis group is the actual intervention group. |
| Usual care | No intervention | –This group is the routine treatment (control) valid in the clinical practice. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unwillingness to continue the study
- Rehospitalization
- Exposure to a disease or trauma that would affect functional independence during the study
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 |
|---|---|---|
| Transitional care modelThe 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. | Other | Transitional care |
Primary outcome
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.
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.
1 secondary outcome
number of hospital visits
Time frame: up to 12 weeks
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 2 Sep 2022.
- Background: PubMed 33074309An 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.
- Background: PubMed 28870302Gaffney CJ, Pelt CE, Gililland JM, Peters CL. Perioperative Pain Management in Hip and Knee Arthroplasty. Orthop Clin North Am. 2017 Oct;48(4):407-419. doi: 10.1016/j.ocl.2017.05.001. Epub 2017 Jun 29.
- Background: PubMed 32950214Magan 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.
- Background: PubMed 24493186Hanusch 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.
- Background: PubMed 33154651Mardani 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.
- Background: PubMed 32322183Allen J, Hutchinson AM, Brown R, Livingston PM. Communication and Coordination Processes Supporting Integrated Transitional Care: Australian Healthcare Practitioners' Perspectives. Int J Integr Care. 2020 Apr 16;20(2):1. doi: 10.5334/ijic.4685.
- Results publication: PubMed 32917145Morkisch 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 publication: PubMed 25485791Hung D, Leidig RC. Implementing a transitional care program to reduce hospital readmissions among older adults. J Nurs Care Qual. 2015 Apr-Jun;30(2):121-9. doi: 10.1097/NCQ.0000000000000091.
- Results publication: PubMed 33146267Costa MFBNAD, Sichieri K, Poveda VB, Baptista CMC, Aguado PC. Transitional care from hospital to home for older people: implementation of best practices. Rev Bras Enferm. 2020 Nov 2;73Suppl 3(Suppl 3):e20200187. doi: 10.1590/0034-7167-2020-0187. eCollection 2020. English, Portuguese.
- Results publication: PubMed 33901941Lyu 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.
- Results publication: PubMed 31985129Liu ZC, Gao L, Zhang WH, Wang J, Liu RR, Cao BH. Effects of a 4-week Omaha System transitional care programme on rheumatoid arthritis patients' self-efficacy, health status, and readmission in mainland China: A randomized controlled trial. Int J Nurs Pract. 2020 Aug;26(4):e12817. doi: 10.1111/ijn.12817. Epub 2020 Jan 27.
- Results publication: PubMed 29851443Kranker K, Barterian LM, Sarwar R, Peterson GG, Gilman B, Blue L, Stewart KA, Hoag SD, Day TJ, Moreno L. Rural hospital transitional care program reduces Medicare spending. Am J Manag Care. 2018 May;24(5):256-260.
- Individual participant dataSharing planned: No
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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.
Betül Tosun, Assoc. Prof. study chair
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional care model in people with Knee Osteoarthritis and Pain, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
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 6 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 2 Sep 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 Turkey (Türkiye). 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?
Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC (time frame: up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525793, which also lists 14 linked publications.
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 2 Sep 2022.