Total Knee Replacement SurgeryNCT05088538
The Effect of Quick Response Coded Teaching Plan, Patients With Total Knee Replacement
A study testing Patient Education in people with Total Knee Replacement Surgery and Patient Education, run by Bozok University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement Surgery, Patient Education
- What is being tested?
- Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2021to 20 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dışkapı Yıldırım Beyazıt Training and Research Hospital
Ankara, Altındag, 06110
Nilgün Özbaş, Assist Prof, +90-354- 314- 14- 15 ext. 1049, nilgun.ozbas06@gmail.com
Mevlude Karadag, +90-312-286-36-01 ext. 2001, mevludekaradag@gmail.com
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Total Knee Replacement Surgery, Patient Education
- Being tested
- Patient Education
- Keywords
- Total knee replacement, Patient education, QR code, Health literacy, Nursing, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start30 Oct 2021 (estimated)
- Primary completion20 Apr 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Nilgun Ozbas, Bozok University
- Investigators
- Nilgün Özbaş, Assist Prof, Principal investigator, Bozok UniversityAhmet Acar, Doctor, Study chair, Dışkapı Yıldırım Beyazıt Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088538
- Sponsor's protocol ID
- 114/05
- Status last verified
- Oct 2021
- First submitted
- 12 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05088538
- Acronym / sponsor ID
- 114/05
- Conditions
- Total Knee Replacement Surgery, Patient Education
- Keywords
- Total knee replacement, Patient education, QR code, Health literacy, Nursing, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 20 Apr 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Patient EducationUnlike the control group, the intervention group will be given the education plan prepared by the researchers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient EducationAfter 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. | Other | Intervention group |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement Surgery
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilgün Özbaş, Assist Prof principal investigator
Bozok University
Ahmet Acar, Doctor study chair
Dışkapı Yıldırım Beyazıt Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education in people with Total Knee Replacement Surgery and Patient Education, run by Bozok University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nilgün Özbaş, Assist Prof (+90-354- 314- 14- 15 ext. 1049, nilgun.ozbas06@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.