NCT05525793

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
Last Updated

September 2, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 25, 2022

Last Update Submit

August 30, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Western Ontario and McMaster Universities Osteoarthritis Index-WOMAC

    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)

    Assessments of self-efficacy of patients were conducted at baseline, 2nd and 9th weeks after discharge.

    up to 9 weeks

Secondary Outcomes (1)

  • number of hospital visits

    up to 12 weeks

Study Arms (2)

Transitional care

EXPERIMENTAL

This group is the actual intervention group.

Other: Transitional care model

Usual care

NO INTERVENTION

This group is the routine treatment (control) valid in the clinical practice.

Interventions

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.

Transitional care

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unwillingness to continue the study
  • Rehospitalization
  • Exposure to a disease or trauma that would affect functional independence during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal Üniversitesi

Antakya, Hatay, 31060, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 33074309BACKGROUND
  • Gaffney 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.

    PMID: 28870302BACKGROUND
  • 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.

    PMID: 32950214BACKGROUND
  • 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.

    PMID: 24493186BACKGROUND
  • 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.

    PMID: 33154651BACKGROUND
  • Allen 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.

    PMID: 32322183BACKGROUND
  • 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.

  • Hung 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.

  • Costa 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.

  • 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.

  • Liu 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.

  • Kranker 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.

  • Nall 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.

MeSH Terms

Conditions

Osteoarthritis, KneePainPatient Acceptance of Health Care

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Betül Tosun, Assoc. Prof.

    Hasan Kalyoncu Üniversitesi

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 25, 2022

First Posted

September 2, 2022

Study Start

February 8, 2021

Primary Completion

August 8, 2021

Study Completion

November 11, 2021

Last Updated

September 2, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations