Total Knee ArthroplastyNCT05088551
The Effect of the Educational Plan Prepared According to the Health Literacy Levels of Patients
A study testing Patient Education in people with Total Knee Arthroplasty and Patient Education, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
The reasons such as the advanced age of most patients with Total Knee Arthroplasty (TKA), the presence of concomitant diseases, and bilateral prostheses cause a decrease in the quality of life by negatively affecting the healing processes of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, 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
- 1 Jun 2018to 1 Apr 2020
- 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
- Patients over 18 years
- Patients who had undergone total knee arthroplasty surgery for the first time
- Patients who did not have a history of psychiatric problems
- Patients who were literate
- Patients who agreed to participate for the study
Who cannot join
- Patients not over 18 years
- Patients who hadn't undergone total knee arthroplasty surgery for the first time
- Patients who had a history of psychiatric problems
- Patients who weren't literate
- Patients who didn' t agree to participate for the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dıskapı Yıldırım Beyazıt Training and Research Hospital
Ankara, Altındag, 06110
About this study
Official title: The Effect of the Educational Plan Prepared According to the Health Literacy Levels of Patients With Total Knee Arthroplasty on the Healing Process and the Quality of Life: Randomized Controlled Study
The reasons such as the advanced age of most patients with Total Knee Arthroplasty (TKA), the presence of concomitant diseases, and bilateral prostheses cause a decrease in the quality of life by negatively affecting the healing processes of the patients. Patients who try to adapt to the problems experienced during postoperative recovery need the information to develop coping behaviors. Nurses play a crucial role in ensuring adequate and effective access of information to the patient during this challenging process, which significantly affects mobility and, consequently, life activities. Effective educational interventions to be implemented by nurses enable patients to make decisions about health problems and act to improve their quality of life. However, for patient education to be efficient, the information given must be easy to read, understandable, and suitable for various learning styles to cope with problems more effectively. Still, individuals with low health literacy have problems benefiting from all services provided, exceptionally patient education, at the desired level.
Read the detailed description
Patients with TKA face many problems in the early postoperative period and home processes after discharge. In this process, the instruction that will be given by nurses as a part of the care is critical. Patient education will contribute to less stress for patients, effective participation in their care, and more minor problems in the recovery process at home after discharge and increase positive patient outcomes. However, for the teaching to be effective, nurses must first determine the health literacy levels of individuals. When initiatives are planned following the level of health literacy, it is thought that individuals' adaptation to the duration of their health will increase, the process will progress effectively, the recovery will be positively affected, and the quality of life will increase. Accordingly, this study was conducted to examine the effect of the curriculum prepared according to patients' health literacy levels with TKA on the healing process and quality of life.
Research hypotheses:
H1a- Patient education, which is planned according to health literacy levels, positively affects patients' quality of life.
H1b- Patient education, which is planned according to health literacy levels, reduces patients' problems on the 15th day after surgery.
H1c- Patient education, which is planned according to health literacy levels, reduces patients' problems in the 6th week after surgery.
H1d- Patient education, which is planned according to health literacy levels, affects the postoperative improvement in functional status in patients.
Study Design: A control group intervention research. Method: 102 patients, 51 experimental groups, and 51 control groups participated in the study. The sample was chosen randomly from the universe by the researcher. From the patients hospitalized in the clinic and matching the research criteria, the control group was determined by random method according to the order of the patients, and their data were collected. Then, the intervention group data were obtained, paying attention to the similarity of the groups in terms of education, age, and gender. In the study, the education plan prepared in line with the control group data was applied to the intervention group, and its effects on the healing processes were observed.
Data were collected with Patient Introduction, Patient Learning Requirements, Functional Evaluation, Turkey Health Literacy, Discharge Data Collection, Post-Discharge 15th and Sixth Week Recovery Process Data Collection, Quality of Life Forms.
- Conditions
- Total Knee Arthroplasty, Patient Education
- Being tested
- Patient Education
- Keywords
- Total knee arthroplasty, Patient education, Nursing, Health literacy, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient EducationOther
The education was divided into three parts. The information in the first part of the booklet (general information, preoperative preparation, and operation day) is given in the preoperative period. In the postoperative period, the patients were visited and the information in the second part (postoperative hospital stay, first, second, and third-day goals after surgery) was given. Before the patients were discharged, the information in the third section (things to be considered in the recovery process at home) was presented. According to the physical conditions of the clinic, patient education was carried out in an area suitable for teaching as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | When the patients were admitted to the clinic,and the face-to-face interview method and the Patient Information Form,Turkey Health Literacy Scale-32,Patient Learning Needs Scale,Functional Assessment Form and Quality of Life Scale Form were filled.The second interview was conducted on the second or third day after the surgery, just before the patients were discharged.The Functional Assessment Form,Discharge Data Collection Form, and Quality of Life Questionnaire were applied.The third interview was performed 15 days after the surgery when the patients came for control or by phone.The 15th Day Recovery Process Data Collection Form were applied.The last interview was carried out six weeks after the surgery,either face-to-face or by phone,and the Functional Assessment Form,6th Week Post-Discharge Recovery Process Data Collection Form,and Quality of Life Questionnaire were applied again.Except for the routine practices of the service,no intervention was made to the control group patients. |
| Intervention group | Experimental | Unlike the control group, the intervention group was given the education plan prepared by the researcher after filling out the forms when the patients were first encountered, and the education was carried out using various training methods such as lecture, question-answer, demonstration, and practice.Patients whose check-up time after discharge was nearing (15 days after the operation) were called a few days before and their visit time was learned. The forms were filled in by interviewing the patients face-to-face by the researcher on the 15th day and the 6th week after the operation or making a phone call on the same day with the patients who could not be reached. 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 3 days, change from baseline the quality of life score at 6 weeks
Secondary outcomes (1)
The Function Evaluation Form Change
The Functional Evaluation Form was developed to determine the functional status of patients who had TKA 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 the function evaluation score at 3 days, change from baseline the function evaluation score at 6 weeks
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 start1 Jun 2018
- Primary completion28 Sep 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Principal investigator, Nilgun Ozbas, Bozok University
- Investigators
- Nilgün Özbaş, Assist. Prof, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088551
- Sponsor's protocol ID
- 14574941- 199-27487
- Status last verified
- Oct 2021
- First submitted
- 4 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 the Educational Plan Prepared According to the Health Literacy Levels of Patients With Total Knee Arthroplasty on the Healing Process and the Quality of Life: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05088551
- Acronym / sponsor ID
- 14574941- 199-27487
- Conditions
- Total Knee Arthroplasty, Patient Education
- Keywords
- Total knee arthroplasty, Patient education, Nursing, Health literacy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Sep 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- 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.
The reasons such as the advanced age of most patients with Total Knee Arthroplasty (TKA), the presence of concomitant diseases, and bilateral prostheses cause a decrease in the quality of life by negatively affecting the healing processes of the patients. Patients who try to adapt to the problems experienced during postoperative recovery need the information to develop coping behaviors. Nurses play a crucial role in ensuring adequate and effective access of information to the patient during this challenging process, which significantly affects mobility and, consequently, life activities. Effective educational interventions to be implemented by nurses enable patients to make decisions about health problems and act to improve their quality of life. However, for patient education to be efficient, the information given must be easy to read, understandable, and suitable for various learning styles to cope with problems more effectively. Still, individuals with low health literacy have problems benefiting from all services provided, exceptionally patient education, at the desired level.
Detailed description
Patients with TKA face many problems in the early postoperative period and home processes after discharge. In this process, the instruction that will be given by nurses as a part of the care is critical. Patient education will contribute to less stress for patients, effective participation in their care, and more minor problems in the recovery process at home after discharge and increase positive patient outcomes. However, for the teaching to be effective, nurses must first determine the health literacy levels of individuals. When initiatives are planned following the level of health literacy, it is thought that individuals' adaptation to the duration of their health will increase, the process will progress effectively, the recovery will be positively affected, and the quality of life will increase. Accordingly, this study was conducted to examine the effect of the curriculum prepared according to patients' health literacy levels with TKA on the healing process and quality of life.
Research hypotheses:
H1a- Patient education, which is planned according to health literacy levels, positively affects patients' quality of life.
H1b- Patient education, which is planned according to health literacy levels, reduces patients' problems on the 15th day after surgery.
H1c- Patient education, which is planned according to health literacy levels, reduces patients' problems in the 6th week after surgery.
H1d- Patient education, which is planned according to health literacy levels, affects the postoperative improvement in functional status in patients.
Study Design: A control group intervention research. Method: 102 patients, 51 experimental groups, and 51 control groups participated in the study. The sample was chosen randomly from the universe by the researcher. From the patients hospitalized in the clinic and matching the research criteria, the control group was determined by random method according to the order of the patients, and their data were collected. Then, the intervention group data were obtained, paying attention to the similarity of the groups in terms of education, age, and gender. In the study, the education plan prepared in line with the control group data was applied to the intervention group, and its effects on the healing processes were observed.
Data were collected with Patient Introduction, Patient Learning Requirements, Functional Evaluation, Turkey Health Literacy, Discharge Data Collection, Post-Discharge 15th and Sixth Week Recovery Process Data Collection, Quality of Life Forms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –When the patients were admitted to the clinic,and the face-to-face interview method and the Patient Information Form,Turkey Health Literacy Scale-32,Patient Learning Needs Scale,Functional Assessment Form and Quality of Life Scale Form were filled.The second interview was conducted on the second or third day after the surgery, just before the patients were discharged.The Functional Assessment Form,Discharge Data Collection Form, and Quality of Life Questionnaire were applied.The third interview was performed 15 days after the surgery when the patients came for control or by phone.The 15th Day Recovery Process Data Collection Form were applied.The last interview was carried out six weeks after the surgery,either face-to-face or by phone,and the Functional Assessment Form,6th Week Post-Discharge Recovery Process Data Collection Form,and Quality of Life Questionnaire were applied again.Except for the routine practices of the service,no intervention was made to the control group patients. |
| Intervention group | Experimental | Other: Patient EducationUnlike the control group, the intervention group was given the education plan prepared by the researcher after filling out the forms when the patients were first encountered, and the education was carried out using various training methods such as lecture, question-answer, demonstration, and practice.Patients whose check-up time after discharge was nearing (15 days after the operation) were called a few days before and their visit time was learned. The forms were filled in by interviewing the patients face-to-face by the researcher on the 15th day and the 6th week after the operation or making a phone call on the same day with the patients who could not be reached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients over 18 years
- Patients who had undergone total knee arthroplasty surgery for the first time
- Patients who did not have a history of psychiatric problems
- Patients who were literate
- Patients who agreed to participate for the study
Key exclusion criteria (5 listed)
- Patients not over 18 years
- Patients who hadn't undergone total knee arthroplasty surgery for the first time
- Patients who had a history of psychiatric problems
- Patients who weren't literate
- Patients who didn' t agree to participate for the study
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 EducationThe education was divided into three parts. The information in the first part of the booklet (general information, preoperative preparation, and operation day) is given in the preoperative period. In the postoperative period, the patients were visited and the information in the second part (postoperative hospital stay, first, second, and third-day goals after surgery) was given. Before the patients were discharged, the information in the third section (things to be considered in the recovery process at home) was presented. According to the physical conditions of the clinic, patient education was carried out in an area suitable for teaching as much as possible. | 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 3 days, change from baseline the quality of life score at 6 weeks
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 the function evaluation score at 3 days, change from baseline the function evaluation score at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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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
Gazi University
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 Arthroplasty 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 5 inclusion and 5 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 3 days, change from baseline the quality of life score at 6 weeks). 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.