Determining the Effect of Individualized Education Program in Kidney Transplant Patients

NCT06674239 | Completed

• 1 other identifier: FBU/2020-60
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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".

Conditions

Kidney Transplantation; Healthy Lifestyle Behaviors; Metabolic Problems

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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".

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".

Interventions

Patient Follow-up and Evaluation Form, Patient Information Form Healthy Lifestyle Behaviors Scale Education Booklet BEHAVIORAL

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".

Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fenerbahce University: lead

Study Sites (1)

Fenerbahce University

Istanbul, Turkey (Türkiye)

Location

Study Officials

• Naile Akinci, 1

  naile.akinci@fbu.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof.

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: November 5, 2024
• Study Start: July 15, 2021
• Primary Completion: October 15, 2021
• Study Completion: July 15, 2022
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)