- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088538
The Effect of Quick Response Coded Teaching Plan, Patients With Total Knee Replacement
The Effect of Quick Response (QR) Coded Teaching Plan, Prepared According to Health Literacy Levels of Patients With Total Knee Replacement Surgery, on Recovery Process and Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nilgün Özbaş, Assist Prof
- Phone Number: 1049 +90-354- 314- 14- 15
- Email: nilgun.ozbas06@gmail.com
Study Contact Backup
- Name: Mevlude Karadag, Professor
- Phone Number: 2001 +90-312-286-36-01
- Email: mevludekaradag@gmail.com
Study Locations
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Altındag
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Ankara, Altındag, Turkey, 06110
- Dışkapı Yıldırım Beyazıt training and research hospital
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Contact:
- Nilgün Özbaş, Assist Prof
- Phone Number: 1049 +90-354- 314- 14- 15
- Email: nilgun.ozbas06@gmail.com
-
Contact:
- Mevlude Karadag
- Phone Number: 2001 +90-312-286-36-01
- Email: mevludekaradag@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
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.
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|
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Experimental: Intervention group
Unlike the control group, the intervention group will be given the education plan prepared by the researchers.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Quality of Life Scale Change (SF-36)
Time Frame: 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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Function Evaluation Form Change
Time Frame: 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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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.
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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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nilgün Özbaş, Assist Prof, Bozok University
- Study Chair: Ahmet Acar, Doctor, Dışkapı Yıldırım Beyazıt training and research hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 114/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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