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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05088538
Other study ID # 114/05
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 30, 2021
Est. completion date September 20, 2022

Study information

Verified date October 2021
Source Bozok University
Contact Nilgün Özbas, Assist Prof
Phone +90-354- 314- 14- 15
Email nilgun.ozbas06@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Individuals who have undergone TKR surgery want to receive information about many subjects such as patient education, recovery, home care, surgery, movement, pain, exercise, walking, nutrition, working life, weight control, illness, complications. It is very important that the information is appropriate for the level of health literacy and that it is provided not only by written but also by various visual, auditory and technological methods in order to effectively transfer the information needed by the patients during the challenging process that significantly affects their mobility and daily living activities. This study was planned as a randomized controlled study in order to examine the effect of the rapid response QR coded teaching plan prepared according to the health literacy levels of the patients who had TKR surgery on the healing process and quality of life. Hypotheses of the study: H1a- Patient education with QR code, which is planned according to health literacy levels, positively affects patients' quality of life. H1b- Patient education with QR code, which is planned according to health literacy levels, reduces patients' problems on the 15th day after surgery. H1c- Patient education with QR code, which is planned according to health literacy levels, reduces patients' problems in the 6th week after surgery. H1d- Patient education with QR code, which is planned according to health literacy levels, affects the postoperative improvement in functional status in patients. Type of Study: Randomized controlled trial Method: 102 (51 intervention, 51 control) patients who underwent TKR surgery will be randomized and divided into two groups as intervention and control groups. No intervention will be made to the patients in the control group and the patients will receive routine treatment and care in the clinic. In addition to the routine treatment and care, the patients in the intervention group will be taught with a QR code prepared by the researcher. Data will be collected using the Patient Identification Form, The Patient Learning Needs Scale, Functional Assessment Form, Knee Assessment Questionnaire, Turkish Health Literacy Scale-32, Discharge Data Collection Form, Post-Discharge Day 15 of the Healing Process Data Collection Form, Post-Discharge Week 6 of the Healing Process Data Collection Form and the Quality of Life Scale. While evaluating the data, it is planned to be analyzed as randomized.It is planned to use multiple completion methods when there are missing data. Statistical analyzes are planned to be evaluated with the Statistical Package for the Social Sciences (SPSS)-24 package program. It is planned to use frequency charts and descriptive statistics in order to interpret the data, parametric techniques for normal distributions and non-parametric techniques for non-normal distributions.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 102
Est. completion date September 20, 2022
Est. primary completion date April 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient Education
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.

Locations

Country Name City State
Turkey Diskapi Yildirim Beyazit Training and Research Hospital Ankara Altindag

Sponsors (2)

Lead Sponsor Collaborator
Bozok University Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 life score at 3rd postoperative day, change from baseline the quality of life score at 6th postoperative week
Secondary The Function Evaluation Form Change The Functional Evaluation Form was developed to determine the functional status of patients who had TKR surgery and hip replacement surgery. The form consists of 8 sections and each section is scored within itself. The highest possible score is 100. The increase in score indicates the improvement in the functional status. 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
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