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临床试验/NCT04798937
NCT04798937已完成不适用

A RCT Using Motivational Interviewing to Improve Self Management in Youth With Type 1 Diabetes

Université de Sousse2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年1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
66
试验地点
2
主要终点
Transition Readiness Assessment Questionnaire (TRAQ) scores

研究概览

简要总结

A brief, nurse-led educational intervention using motivational interviewing substantially improved general and disease-specific self-management skills in youth with type 1 diabetes.

详细描述

Introduction and Objectives: For youth with chronic health conditions, adolescence is associated with a deterioration of disease self-management and poor health outcomes. Effective interventions are needed to prepare youth for transition to adulthood and adult care. To prospectively assess the impact of an education program based on motivational interviewing on self-management skills and glycemic control in youth with Type 1 diabetes (T1D).

Methods: After parental consent and youth assent, investigators prospectively randomized 66 adolescents 13-18 years old with type 1 diabetes to either usual care (regular medical consultation) or usual care supplemented by sessions with a nurse educator using a motivational interviewing (MI) approach and goal setting based on responses to the Transition Readiness Assessment Questionnaire (TRAQ) and T1D specific self-management skills. Primary outcomes were TRAQ change scores and HbA1c levels between baseline and 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Being diagnosed with type 1 diabetes
  • Having an age between 13 and 18 years

排除标准

  • Having a neurological disability (epilepsy, autism)
  • Having a significant intellectual delay, which might have affected their ability to understand the content of the program

结局指标

主要结局

Transition Readiness Assessment Questionnaire (TRAQ) scores

时间窗: Change from Baseline TRAQ score at 6 months

The TRAQ includes 20 items divided into five subscales: 1) Appointment keeping (7 questions; e.g., Do you call the doctor's office to make an appointment?) 2) Tracking health issues (4 questions; e.g., Do you keep a calendar or list of medical and other appointments?); 3) Managing medications (4 questions; e.g., Do you know what to do if you are having a bad reaction to your medications?); 4) Talking with healthcare providers (2 questions; e.g. Do you tell the doctor or nurse what you are feeling?); 5) Managing daily activities (3 questions; e.g. Do you help plan or prepare meals/food?). Each question has the same Liker response set from 1 to 5 using the Stages of Change Transtheoretical Model as a framework. A minimum score of ''1'' is assigned to the responses 'No, I don't know how' while a maximum score of '' 5 '' is assigned to responses labeled "Yes, I always do it when I need it." Higher scores mean better outcome.

次要结局

  • Hemoglobin glycated values(Change from Baseline Hemoglobin glycated values at 6 months)

研究者

发起方
Université de Sousse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kawther Al ksir

Principal Investigator

Université de Sousse

研究点 (2)

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