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临床试验/NCT03083899
NCT03083899已完成不适用

DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits

Esbjerg Hospital - University Hospital of Southern Denmark2 个研究点 分布在 1 个国家目标入组 357 人开始时间: 2017年3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
357
试验地点
2
主要终点
Patient reported outcome

研究概览

简要总结

People with Type 1 diabetes (T1D) are randomized to follow the normal scheduled visit procedure in the outpatient clinic OR to have open access to the clinic, i.e. they can get an appointment with a nurse or doctor within defined time intervals via telephone, e-mail or apps. Patient-reported outcomes (patient satisfaction and experience, QoL) clinical variables (HbA1c, blood pressure etc.) and use of human resources (doctors, diabetes-nurses and diet physicians) are monitored.

详细描述

This is a 24 month prospective randomized controlled trial. People with Type 1 diabetes (T1D) are randomized to two groups: (i) Patients randomized to the control group receive their standard diabetes care and are seen in the out-patient clinic with regular intervals (typically a diabetes nurse every 3-4 month and a diabetes doctor once a year. (ii) Patients randomized to the intervention group are not called for at fixed time points. They can arrange visits in the diabetes clinic whenever they feel the need to do so. The have a guarantee for a consultation with a diabetes nurse within one week and with a diabetes doctor or diet physician within two weeks. Questionnaires (a specific questionnaire focused on patient satisfaction developed for the study and AddQoL) are filled in at time 0 and 24 month. Blood samples for diabetes-related variables (HbA1c, lipid status), blood pressure, body weight etc. are likewise recorded at time 0 and 24 month. Economic and time requirements are evaluated at 24 month.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 diabetes 18 - 80 years Multiple injections or Insulin pump therapy

排除标准

  • Newly diagnosed T1D Psychiatric illness Need for translation Unstable conditions such as progressive retinopathy

结局指标

主要结局

Patient reported outcome

时间窗: 24 month

Questionnaire regarding satisfaction of the out-patient clinic

次要结局

  • Diabetes Dependent quality of Life(24 month)
  • Clinical diabetes variables 1(24 month)
  • Health Care Economy(24 month)
  • Clinical diabetes variables 2(24 month)
  • Clinical diabetes variables 3(24 month)

研究者

发起方
Esbjerg Hospital - University Hospital of Southern Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claus Bogh Juhl

MD, PhD, Ass Professor

Esbjerg Hospital - University Hospital of Southern Denmark

研究点 (2)

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