Clinical trial NCT06674239: Determining the Effect of Individualized Education Program in Kidney Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Healthy Lifestyle Behaviors
Metabolic Problems
Lead sponsor: Fenerbahce University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* patient aged ≥18 years
* literate
* volunteering to participate in the study
* having received a kidney transplant

Exclusion Criteria:

* patient with communication or psychiatric disorder
* having received two or more kidney transplants

Primary outcomes:
measure: Education given to kidney transplant patients will change healthy lifestyle behaviors.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fenerbahce University
Study officials:
affiliation: naile.akinci@fbu.edu.tr
name: Naile Akinci, 1
role: PRINCIPAL_INVESTIGATOR
References: