NCT05088538

Brief Summary

With the developments in the field of health, Total Knee Replacement (TKR) surgeries are performed by applying evidence-based rapid recovery programs in many hospitals and patients can be discharged in a very short time. This situation imposes more responsibilities on patients and their relatives, especially in the post-operative period, for undertaking care, managing developing health-related conditions, and advancing the treatment process in a positive way. For this reason, it is very important for patients and their relatives to receive training before discharge on issues such as adaptation to daily life, movement, self-care skills, and complications related to post-operative home care. The fact that patients who have TKR surgery are mostly elderly individuals also increases the importance of the subject. At the same time, in order for patient education to be effective, it is very important that the information given is suitable for the level of health literacy, easily readable and understandable in a way that patients can understand. If the transmitted information is not presented in an easy and understandable way, the musculoskeletal functions, quality of life and socio economic productivity of the patients after the surgery will be endangered. In addition, patient education given to patients is not only written; Using visual, auditory and technological materials such as various presentations, videos, photographs, in accordance with different learning styles, provides a more effective coping with the problems in the post-operative period and reduces physical and psychological problems. In this context, it is seen that the use of QR code, which is a digital technological application that has recently been used in the field of health, is an application that can provide an easier understanding of the information transmitted verbally and in writing by healthcare professionals.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

September 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

October 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

September 12, 2021

Last Update Submit

October 9, 2021

Conditions

Keywords

Total knee replacementPatient educationQR codeHealth literacyNursingQuality of life

Outcome Measures

Primary Outcomes (1)

  • The Quality of Life Scale Change (SF-36)

    The Quality of Life Scale (SF-36), one of the most used scales to measure quality of life; It is a self-assessment scale that can be filled in a short time and is highly sensitive.While applying the scale, individuals are asked to answer considering the last 4 weeks. The scale consists of 36 questions and 8 sub-parameters (body pain, limitation due to physical problems, limitation due to mental problems, mental well-being, fatigue, general health perception, social function and physical function). In scoring, each parameter is evaluated between 0 and 100 points. A score of 0 indicates poor health, and a score of 100 indicates good health. The higher the score, the higher the quality of life.

    1st day of admission to the clinic change the quality of life score at before intervention, change from baseline the quality of lıfe score at 3rd postoperative day, change from baseline the quality of life score at 6th postoperative week

Secondary Outcomes (1)

  • The Function Evaluation Form Change

    1st day of admission to the clinic change the function evaluation score at before intervention, change from baseline function evaluation score at 3rd postoperative day, change from baseline function evaluation score at 6th postoperative week

Study Arms (2)

Control group

NO INTERVENTION

When the patients are in clinic,The Patient Information Form,Turkey Health Literacy Scale-32,Patient Learning Needs Scale,Functional Assessment Form,Knee Assessment Questionnaire and Quality of Life Scale Form will be filled.The second interview will be conducted on the second or third day after the surgery, just before the patients will be discharged.The Functional Assessment Form,Knee Assessment Questionnaire,Discharge Data Collection Form, and Quality of Life Questionnaire will be applied.The third interview will be performed 15 days after the surgery when the patients come for control or by phone.The 15th Day Recovery Process Data Collection Form and Knee Assessment Questionnaire will be applied.The last interview will be carried out six weeks after the surgery,either face-to-face or by phone,and the Functional Assessment Form,Knee Assessment Questionnaire, 6th Week Post-Discharge Recovery Process Data Collection Form,and Quality of Life Questionnaire will be applied again.

Intervention group

EXPERIMENTAL

Unlike the control group, the intervention group will be given the education plan prepared by the researchers.

Other: Patient Education

Interventions

After completing the necessary forms, it is planned to give the QR-coded education booklet prepared by the researcher to the patients and to inform the patients and their relatives about the use of QR codes. At that time, it is planned that the teaching will be carried out using various training methods such as lecture, question-answer, demonstration and practice. It is thought that the teaching will be divided into 3 parts: pre-operative, post-operative and discharge. According to the physical conditions of the clinic, it is planned to provide patient education in an suitable area for teaching as much as possible. Patients will be reminded that they can access the information whenever they want and as many times as they want by scanning the QR code from their phone.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not having knee replacement surgery before
  • Not having a history of psychiatric problems
  • Having known how to read and write
  • Having a smart phone
  • Having internet access on the phone
  • Having been agreed to participate in the research

You may not qualify if:

  • Having previous knee replacement surgery
  • Having a history of psychiatric problems
  • Not having known how to read and write
  • Not having a smart phone
  • Not having internet access on the phone
  • Not having been agreed to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dışkapı Yıldırım Beyazıt Training and Research Hospital

Ankara, Altındag, 06110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Nilgün Özbaş, Assist Prof

    Bozok University

    PRINCIPAL INVESTIGATOR
  • Ahmet Acar, Doctor

    Dışkapı Yıldırım Beyazıt Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Nilgün Özbaş, Assist Prof

CONTACT

Mevlude Karadag, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The assignment to the groups will be carried out by an independent researcher, and the group will be notified via telephone after the practitioner researcher has approved, evaluated the criteria and performed the pre-tests. At the same time, groups will be named A and B and researchers will be blinded during statistical analysis and reporting.It will not be disclosed to the participants and their caregivers in which group they belong. Surveys will be filled in by a different independent researcher blinded to the groups
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 12, 2021

First Posted

October 22, 2021

Study Start

October 30, 2021

Primary Completion

April 20, 2022

Study Completion

September 20, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations