Determining the Effect of Individualized Education Program in Kidney Transplant Patients

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".

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation; Healthy Lifestyle Behaviors; Metabolic Problems
• Intervention / Treatment: Behavioral: Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Fenerbahçe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education; 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".	Behavioral: Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet; 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".
No Intervention: Observation; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Fenerbahce University
• Investigators: Principal Investigator: Naile Akinci, 1, naile.akinci@fbu.edu.tr

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: FBU/2020-60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No