NCT06130813

Brief Summary

Total knee replacement (TKA) is a surgical procedure to increase the function of the knee joint. However, in the postoperative period, it takes a long time for patients to gain independence and adapt to daily life, and they need information and support. The aim of this study is to determine the effect of the increased perioperative communication program (IPCP) in patients with TKA on early postoperative complications.

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

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

November 30, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

November 9, 2023

Last Update Submit

October 2, 2024

Conditions

Keywords

knee arthroplastycommunication programcomplicationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    The investigators expect the IPCP to reduce early postoperative complications

    30 days

Study Arms (2)

Increased perioperative communication program

EXPERIMENTAL

The sample of the research is; it was determined as 70 patients by G. Power analysis based on the correlation coefficients in a sample study. 35 of the patients will be assigned to the intervention group (IG) and 35 to the control group (CG). Patients in the CG will receive routine perioperative care, while patients in the IG will be included in the IPCP. All patients will be followed for one month after discharge. IPCP consists of 8 informative contents such as preoperative preparations, surgical procedure, pain management, first mobilization, knee joint movements, exercise, discharge process, wound care, showering, nutrition, daily living activities, driving, sexual life, postoperative routine control, unexpected situations and etc. These informative contents will send to patients on days 7th, 4t and 1th days before the surgery and on days 1th, 2th, 3th, 5th an 7th days after surgery via whatsapp. Additionally, all participants will follow postoperative one month.

Other: increased perioperative communication program

Standart of care

NO INTERVENTION

Patients in the control group will receive routine perioperative care and will follow postoperative for one month.

Interventions

Thanks to this communication program, informative content (8 times) will be shared with patients.

Increased perioperative communication program

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Elective primary unilateral knee arthroplasty planned,
  • Having a smartphone,
  • Literate,
  • Have no communication problems and
  • Agreed to participate in the study were included.

You may not qualify if:

  • Those with revision total knee arthroplasty
  • Those with bilateral total knee arthroplasty
  • Those with speech and hearing disabilities and cognitive problems such as Alzheimer's and dementia
  • Patients who do not agree to participate in the study will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cigdem Canbolat Seyman

Ankara, Altındağ, 06600, Turkey (Türkiye)

Location

Related Publications (5)

  • Yoon RS, Nellans KW, Geller JA, Kim AD, Jacobs MR, Macaulay W. Patient education before hip or knee arthroplasty lowers length of stay. J Arthroplasty. 2010 Jun;25(4):547-51. doi: 10.1016/j.arth.2009.03.012. Epub 2009 May 8.

  • Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19.

  • Karimi AH, Shah AK, Hecht CJ 2nd, Burkhart RJ, Acuna AJ, Kamath AF. Readability of Online Patient Education Materials for Total Joint Arthroplasty: A Systematic Review. J Arthroplasty. 2023 Jul;38(7):1392-1399. doi: 10.1016/j.arth.2023.01.032. Epub 2023 Jan 27.

  • Stewart MA. Effective physician-patient communication and health outcomes: a review. CMAJ. 1995 May 1;152(9):1423-33.

  • Clarke HD, Timm VL, Goldberg BR, Hattrup SJ. Preoperative patient education reduces in-hospital falls after total knee arthroplasty. Clin Orthop Relat Res. 2012 Jan;470(1):244-9. doi: 10.1007/s11999-011-1951-6.

MeSH Terms

Conditions

Postoperative ComplicationsCommunication

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Cigdem Canbolat Seyman, PHD

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 14, 2023

Study Start

November 30, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

October 3, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The investigators will talk about sharing data with other researchers. But it can be useful.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
March 2024
Access Criteria
Data from this study can be open to all other clinical trial researchers.

Locations