Kidney TransplantationNCT06674239
Determining the Effect of Individualized Education Program in Kidney Transplant Patients
A study testing Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet in people with Kidney Transplantation and Healthy Lifestyle Behaviors, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to determine the effect of an individualized education program on the development of healthy lifestyle behaviors and the prevention of postoperative cardiometabolic problems in patients undergoing kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation, Healthy Lifestyle Behaviors, Metabolic Problems
- What is being tested?
- Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 15 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patient aged ≥18 years
- literate
- volunteering to participate in the study
- having received a kidney transplant
Who cannot join
- patient with communication or psychiatric disorder
- having received two or more kidney transplants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Effect of an Individualized Education Program on Developing Healthy Lifestyle Behaviors and Preventing Postoperative Metabolic Problems in Patients Receiving a Kidney Transplant: A Randomized Controlled Study
Objective: The aim of this study is to determine the effect of an individualized education program on the development of healthy lifestyle behaviors and the prevention of postoperative cardiometabolic problems in patients undergoing kidney transplantation. Methods: The study was conducted in the organ transplantation unit of a private hospital between July 2021 and July 2022. The sample size of this randomized controlled trial was determined through power analysis. Patients were randomized into groups using software. Two groups were formed, experimental and control groups, each with 30 patients. Informed consent forms were signed by patients in the experimental and control groups. Data were collected using the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" applied as pre-test and post-test. Laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form".
Read the detailed description
Kidney transplantation is the most effective way to reduce high morbidity and mortality in patients with end-stage renal disease. This success has been further enhanced by improvements in immunosuppressive therapy, surgical techniques, and medical care. However, kidney transplantation does not completely reverse the years of decreased renal function and damage caused by dialysis. In addition, new irritants (especially immunosuppressives) added in the post-transplant period can cause problems such as weight gain, impaired glucose tolerance, or diabetes, hypertension, and lipid disorders. Unhealthy lifestyle habits can increase the risk of medical complications in dialysis and transplant patients. On the other hand, the presence of these complications reduces graft efficiency in patients and increases cardiovascular risk. Post-transplant care requires the involvement of multidisciplinary healthcare professionals who must work collaboratively with the patient, the patient's family, and healthcare providers. The outcomes of kidney transplantation are significantly affected by the kidney recipient's ability to adhere to a complex and ongoing self-management regimen. Nurses play an important role in developing the patient's self-efficacy and transforming him/her from a dependent person to a self-sufficient person. The American Nurses Association defines the role of the nurse in health development as "the nurse is responsible for ensuring that individuals and groups adapt to actual and potential health problems, assessing the environment that affects the individual's health, and implementing health-promoting nursing interventions." In this context, the transplant nurse should determine the patient's developmental needs and help him/her acquire healthy lifestyle behaviors, activities of daily living, and preventive practices for self-care. The patient's acquisition of healthy lifestyle behaviors after transplantation should be a part of clinical management. Our literature review showed that studies on this subject are insufficient.
The aim of kidney transplantation is not only to reduce the cost of care while improving kidney function, but also to extend the patient's life, improve the quality of life, and provide a healthy lifestyle and life satisfaction. Considering this information, this study was conducted to determine the effect of an individualized education program on improving healthy lifestyle behaviors and preventing cardiometabolic problems after surgery in kidney transplant patients.
- Being tested
- Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education BookletBehavioural
In the experimental phase of the study, an informed consent form, patient information form, healthy lifestyle behaviors scale, patient follow-up and evaluation form and education booklet were used.
Patient Information Form: This form was developed by the researchers. Healthy Lifestyle Behaviors Scale: The scale, which measures the health-promoting behaviors associated with the individual's healthy lifestyle, consists of a total of 52 items.
Patient Follow-up and Evaluation Form: Metabolic value tests are routinely requested in the institution.
Education Booklet: An education booklet was created based on the literature and the opinions of three experts.
Data collection method: Individualized education was given to the experimental group. Then, the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form".
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | In the experimental phase of the study, an informed consent form, patient information form, healthy lifestyle behaviors scale, patient follow-up and evaluation form and education booklet were used.
Patient Information Form: This form was developed by the researchers. Healthy Lifestyle Behaviors Scale: The scale, which measures the health-promoting behaviors associated with the individual's healthy lifestyle, consists of a total of 52 items.
Patient Follow-up and Evaluation Form: Metabolic value tests are routinely requested in the institution.
Education Booklet: An education booklet was created based on the literature and the opinions of three experts.
Data collection method: Individualized education was given to the experimental group. Then, the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form". Receives: Behavioral: Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet |
| Observation | No intervention | Data collection method: Face-to-face interviews were used to inform the patients in the control group about the study and the interview lasted approximately 10-15 minutes. The patients in the control group signed an "informed consent form". The "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test in the control group. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Education given to kidney transplant patients will change healthy lifestyle behaviors.
Healthy Lifestyle Behaviors Scale: Measures the health-promoting behaviors associated with an individual's healthy lifestyle and consists of a total of 52 items and 6 subscales. The lowest score that can be obtained from the scale is 15, and the highest score is 75. As the score obtained from the scale increases, it is seen that the individual has developed a healthy lifestyle.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start15 Jul 2021
- Primary completion15 Oct 2021
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ogr. Uyesi Naile, Fenerbahce University
- Investigators
- Naile Akinci, 1, Principal investigator, naile.akinci@fbu.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674239
- Sponsor's protocol ID
- FBU/2020-60
- Status last verified
- Nov 2024
- First submitted
- 25 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of an Individualized Education Program on Developing Healthy Lifestyle Behaviors and Preventing Postoperative Metabolic Problems in Patients Receiving a Kidney Transplant: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06674239
- Acronym / sponsor ID
- FBU/2020-60
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Nov 2024 (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.
Objective: The aim of this study is to determine the effect of an individualized education program on the development of healthy lifestyle behaviors and the prevention of postoperative cardiometabolic problems in patients undergoing kidney transplantation. Methods: The study was conducted in the organ transplantation unit of a private hospital between July 2021 and July 2022. The sample size of this randomized controlled trial was determined through power analysis. Patients were randomized into groups using software. Two groups were formed, experimental and control groups, each with 30 patients. Informed consent forms were signed by patients in the experimental and control groups. Data were collected using the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" applied as pre-test and post-test. Laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form".
Detailed description
Kidney transplantation is the most effective way to reduce high morbidity and mortality in patients with end-stage renal disease. This success has been further enhanced by improvements in immunosuppressive therapy, surgical techniques, and medical care. However, kidney transplantation does not completely reverse the years of decreased renal function and damage caused by dialysis. In addition, new irritants (especially immunosuppressives) added in the post-transplant period can cause problems such as weight gain, impaired glucose tolerance, or diabetes, hypertension, and lipid disorders. Unhealthy lifestyle habits can increase the risk of medical complications in dialysis and transplant patients. On the other hand, the presence of these complications reduces graft efficiency in patients and increases cardiovascular risk. Post-transplant care requires the involvement of multidisciplinary healthcare professionals who must work collaboratively with the patient, the patient's family, and healthcare providers. The outcomes of kidney transplantation are significantly affected by the kidney recipient's ability to adhere to a complex and ongoing self-management regimen. Nurses play an important role in developing the patient's self-efficacy and transforming him/her from a dependent person to a self-sufficient person. The American Nurses Association defines the role of the nurse in health development as "the nurse is responsible for ensuring that individuals and groups adapt to actual and potential health problems, assessing the environment that affects the individual's health, and implementing health-promoting nursing interventions." In this context, the transplant nurse should determine the patient's developmental needs and help him/her acquire healthy lifestyle behaviors, activities of daily living, and preventive practices for self-care. The patient's acquisition of healthy lifestyle behaviors after transplantation should be a part of clinical management. Our literature review showed that studies on this subject are insufficient.
The aim of kidney transplantation is not only to reduce the cost of care while improving kidney function, but also to extend the patient's life, improve the quality of life, and provide a healthy lifestyle and life satisfaction. Considering this information, this study was conducted to determine the effect of an individualized education program on improving healthy lifestyle behaviors and preventing cardiometabolic problems after surgery in kidney transplant patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education BookletIn the experimental phase of the study, an informed consent form, patient information form, healthy lifestyle behaviors scale, patient follow-up and evaluation form and education booklet were used. Patient Information Form: This form was developed by the researchers. Healthy Lifestyle Behaviors Scale: The scale, which measures the health-promoting behaviors associated with the individual's healthy lifestyle, consists of a total of 52 items. Patient Follow-up and Evaluation Form: Metabolic value tests are routinely requested in the institution. Education Booklet: An education booklet was created based on the literature and the opinions of three experts. Data collection method: Individualized education was given to the experimental group. Then, the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form". |
| Observation | No intervention | –Data collection method: Face-to-face interviews were used to inform the patients in the control group about the study and the interview lasted approximately 10-15 minutes. The patients in the control group signed an "informed consent form". The "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test in the control group. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged ≥18 years
- literate
- volunteering to participate in the study
- having received a kidney transplant
Key exclusion criteria (2 listed)
- patient with communication or psychiatric disorder
- having received two or more kidney transplants
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 Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education BookletIn the experimental phase of the study, an informed consent form, patient information form, healthy lifestyle behaviors scale, patient follow-up and evaluation form and education booklet were used. Patient Information Form: This form was developed by the researchers. Healthy Lifestyle Behaviors Scale: The scale, which measures the health-promoting behaviors associated with the individual's healthy lifestyle, consists of a total of 52 items. Patient Follow-up and Evaluation Form: Metabolic value tests are routinely requested in the institution. Education Booklet: An education booklet was created based on the literature and the opinions of three experts. Data collection method: Individualized education was given to the experimental group. Then, the "Patient Information Form" and the "Healthy Lifestyle Behaviors Scale" were applied as pre-test and post-test. The laboratory values of the patients were examined and recorded in the "Patient Follow-up and Evaluation Form". | Behavioural | Education |
Primary outcome
Education given to kidney transplant patients will change healthy lifestyle behaviors.
Time frame: 1 year
Healthy Lifestyle Behaviors Scale: Measures the health-promoting behaviors associated with an individual's healthy lifestyle and consists of a total of 52 items and 6 subscales. The lowest score that can be obtained from the scale is 15, and the highest score is 75. As the score obtained from the scale increases, it is seen that the individual has developed a healthy lifestyle.
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 5 Nov 2024.
- 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.
Naile Akinci, 1 principal investigator
naile.akinci@fbu.edu.tr
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 Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet in people with Kidney Transplantation and Healthy Lifestyle Behaviors, run by Fenerbahce 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 4 inclusion and 2 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 5 Nov 2024. 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?
Education given to kidney transplant patients will change healthy lifestyle behaviors. (time frame: 1 year). 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 5 Nov 2024.