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临床试验/NCT07430449
NCT07430449已完成不适用

The Effect of Education Given According to Roy's Adaptation Model to Kidney Patients Undergoing Immunosuppressive Therapy on Self-Efficacy, Immunosuppressive Therapy, and Chronic Disease Adaptation Levels

Trakya University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Patient Information Form-1

研究概览

简要总结

Background and Aim: Immunosuppressive therapies administered after chronic kidney disease and kidney transplantation are critically important for patients' life adaptation and the continued success of transplantation. However, the process of compliance with immunosuppressive therapy is not limited to regular medication use; it is closely related to multidimensional factors such as disease adjustment, physical adjustment, psychological balance, social functioning, and the individual's level of self-efficacy. This study aimed to examine the effect of Roy's Adaptation Model-based education on the adherence of patients with chronic kidney disease or kidney transplantation undergoing immunosuppressive therapy to immunosuppressive therapy, their adaptation to the disease, and their self-efficacy levels.

Material and Methods: This quasi-experimental study with a pretest-posttest control group design was conducted with 78 chronic kidney disease patients who were scheduled to receive immunosuppressive therapy for the first time between November 2024 and June 2025 at the nephrology and transplantation services of a university hospital. Data were collected using the "Patient Information Form," "Immunosuppressive Drug Adherence Scale," "Chronic Disease Coping Scale," and "General Self-Efficacy Scale."

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving immunosuppressive therapy for the first time at the nephrology and transplantation clinics of Trakya University Hospital,
  • Aged 18 years or older,
  • Literate,
  • Without communication or mental disorders,
  • Without motor skill impairments,
  • Patients who consent to participate in the study

排除标准

  • Patients who are not willing to participate in the study,
  • Patients who are illiterate,
  • Patients with communication or mental problems,
  • Patients with motor skill problems,
  • Patients who wish to withdraw from the study at any stage,
  • Patients who do not attend follow-up appointments,
  • Patients undergoing dialysis treatment and not receiving immunosuppressive therapy

研究组 & 干预措施

Intervetion Group

Experimental

group given training in accordance with the training booklet

干预措施: training booklet (Device)

control group

No Intervention

group that is not interfered with

结局指标

主要结局

Patient Information Form-1

时间窗: at baseline

The Patient Information Form-1 contains questions regarding patients' individual characteristics, such as age, gender, educational status, marital status, and place of residence.

The Patient Information Form-2

时间窗: at baseline, and at the first and third months.

The Patient Information Form-2 contains treatment-related questions, such as types of immunosuppressive drugs, experience of side effects, whether a special diet is being followed, and the level of compliance with the diet.

Immunosuppressive Drug Compliance Scale

时间窗: at baseline, and at the first and third months

The scale was developed by Özdemir et al. to assess compliance with immunosuppressive drug use in patients who have undergone solid organ transplantation. The scale consists of 11 items in a unidimensional structure and uses both a 5-point Likert-type and a 2-point (Yes-No) rating system for scoring. In the 5-point Likert-type rating, positive items are scored from 1 to 5, while negative items are scored in the opposite direction, from 5 to 1. For items answered with "Yes-No," the 'Yes' response is scored as 1, and the "No" response is scored as 5. All items except the 4th and 6th items are negative and are scored in reverse. The total score that can be obtained from the scale ranges from 11 to 55, with high scores indicating a high level of compliance with immunosuppressive drug use. In the validity-reliability study conducted by Özdemir and colleagues, the Cronbach's alpha coefficient of the scale was found to be 0.611.

Chronic Disease Adjustment Scale

时间窗: at baseline, and at the first and third months.

The scale was developed by Atik and Karatepe and consists of three subscales: physical, social, and psychological adjustment. The physical adjustment subscale consists of 11 items (1, 9, 10, 13, 14, 15, 16, 18, 22, 23, 24), the social adjustment subscale consists of 7 items (2, 3, 5, 7, 17, 19, 25), and the psychological adjustment subscale consists of 7 items (4, 6, 8, 11, 12, 20, 21). This scale, consisting of a total of 25 items, is evaluated using a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree). The total score that can be obtained from the scale ranges from 25 to 125. High scores on the subscales or the total scale indicate a high level of adaptation to the illness. The Cronbach alpha value reported in the study where the scale was developed is 0.88.

General Self-Efficacy Scale

时间窗: at baseline, and at the first and third months.

The General Self-Efficacy Scale was developed by Aypay to assess individuals' perceptions of their competence in coping with difficulties they encounter. The scale consists of 10 items with a four-point Likert-type rating. Participants respond to each item with options ranging from "Not at all true (1)" to "Completely true (4)". The total score range that can be obtained from the scale is between 10 and 40, and an increase in the score level indicates that the individual's perception of self-efficacy is also high. The Cronbach alpha value of the scale was stated as 0.83 in the study in which it was developed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

İDİL ŞAHİN

master student

Trakya University

研究点 (1)

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