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临床试验/NCT06694467
NCT06694467已完成不适用

Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes: An Experimental Evaluation of the Family Centered Empowerment Model

Near East University, Turkey1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Glycosylated hemoglobin level

研究概览

简要总结

Empowerment in healthcare, particularly in the context of chronic illness management such as diabetes, entails equipping patients with knowledge, expertise, and self-assurance to proactively oversee their health and make well-informed choices. This encompasses comprehensive strategies that target psychological, social, and lifestyle elements with the goal of enhancing self-confidence and health results. The objective of this research is to evaluate how the Family-Centered Empowerment Model affects the clinical and psychological outcomes of adolescents with Type 1 Diabetes, with an emphasis on increases in quality of life, self-efficacy, and glycosylated hemoglobin (HbA1c) levels.

详细描述

Diabetes mellitus (DM) is a prevalent and increasingly acknowledged medical disorder that affects individuals worldwide. It is a metabolic condition marked by elevated blood glucose levels that can cause serious side effects like renal failure, heart disease, blindness, and even amputations. To provide a better understanding of the Family-Centered Empowerment Model intervention applied in this work, the components and delivery modes are described in more detail below. Furthermore, a figure or a table suggested at this part could help to present this information more shortly. Details about the intervention The Family-Centered Empowerment Model intervention aimed to help engage the adolescent, an individual with type 1 DM, and his/her family in the self management process. The purpose of this study was to improve coping skills with type 1 DM population by increasing teamwork between adolescents and their members of their household.

研究设计

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

入排标准

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

入选标准

  • Individuals with type 1 diabetes, ages 12 to 18 years
  • Patients who had not taken part in any professional diabetes education program within a month of receiving their diagnosis
  • Patients who had been diagnosed at least six months earlier to the commencement of the study.

排除标准

  • Adolescents who had severe long-term diseases
  • Patients newly diagnosed type 1 diabetes.
  • those who were enrolled in a diabetes education program one month or less prior to the commencement of the study.

结局指标

主要结局

Glycosylated hemoglobin level

时间窗: 6 months

Serum glycosylated hemoglobin level was measured as a baseline, then 6 months after the intervention, to measure the mean difference between the two readings.

Quality of life

时间窗: 6 months

Pediatric Quality of Life-Diabetes Module was used. The twenty-eight items in this multidimensional tool are categorized into five domains: treatment obstacles (four items), treatment adherence (seven items), concern (three items), and diabetic symptoms (eleven items). For teenage self-report, a five-point Likert scale was employed. The total number of questions divided by the total number of answers is how scale scores are calculated.

次要结局

未报告次要终点

研究者

发起方
Near East University, Turkey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Salah Alzawahreh

RN, MSc

Near East University, Turkey

研究点 (1)

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