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临床试验/NCT05680207
NCT05680207已完成不适用

The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial

Kutahya Health Sciences University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2019年3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
发起方
入组人数
216
试验地点
1
主要终点
improvement in The Diabetes Empowerment Scale scores

研究概览

简要总结

In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.

详细描述

The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.

The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.

In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.

Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.

Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.

研究设计

研究类型
Interventional
分配方式
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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago

排除标准

  • •Mental retardation
  • •Blindness
  • •Psychiatric illness
  • •Steroid use

研究组 & 干预措施

Intervention group

Active Comparator

Type 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week

干预措施: Diabetes self- management education (DSME) program (Behavioral)

Control group

No Intervention

Type 2 Diabetes Mellitus patients who did not receive a empowerment training program

结局指标

主要结局

improvement in The Diabetes Empowerment Scale scores

时间窗: 3 months

The Diabetes Empowerment Scale (DES-28) questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score was divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140). All items have been scored so that a higher value indicates stronger empowerment.

次要结局

  • improvement in HbA1c levels(6 months)
  • improvement in fasting glucose(6 months)
  • improvement in low density lipoprotein(6 months)
  • improvement in triglyceride(6 months)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muzelfe BIYIK

Master of Science

Kutahya Health Sciences University

研究点 (1)

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