DiaTast - Patient Reported Experience in a New Out-patient Structure With Patient-initiated Visits
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
- 否
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
Claus Bogh Juhl
MD, PhD, Ass Professor
Esbjerg Hospital - University Hospital of Southern Denmark