DiabetesFlex - Patient Involvement and Patient-reported Outcome Measures in Type 1 Diabetes: A Randomised Controlled Trial and Interview Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The aim of this study is to investigate the effect of the use of DiabetesFlex in diabetes care compared to standard care in relation to patient involvement and relevance for specific group of persons with T1DM.
The investigators hypothesize that the use of DiabetesFlex will lead to a higher degree of patient in-volvement, improved glycaemic control and a decrease in total number of consultations compared to standard care. Furthermore, the investigators aim to identify if a specific sub-population within the T1DM population will benefit significantly from the intervention.
详细描述
Diabetes Mellitus (DM) is a chronic condition, and provision of individual and effective diabetes care is a major challenge. The is a lack of evidence on the optimal frequency of attending outpatient clinics for persons with T1DM.
The use of patient-reported outcome (PRO) measures in diabetes care area are limited and none existing in a Danish context. This includes studies, which combine PRO measure with diabetes management, patient involvement and self-management.
The study will generate knowledge and directions for ways to reframe and to optimize the future management of diabetes care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years Have had T1DM for more than 1 years Be able to use the Danish-language general website on healthcare www.sundhed.dk Be mentally well functioning Understand and read Danish Access to internet
排除标准
- 未提供
结局指标
主要结局
HbA1c
时间窗: 15 mounth
Non-inferiority with respect to HbA1c
次要结局
- Patient Activated Measure (PAM)(15 mounth)
- "Generic questions concerning patient involvement" is validate by "DEFACTUM"(15 mounth)
- General health will be assessed by items from the SF-36 questionnaire(15 mounth)
- Health literacy will be assessed by The Health Literacy Questionnaire (sub scale 6 and 9)(15 mounth)
- The problem Areas In Diabetes Scale (PAID)(15 mounth)
- Number and type consultations(15 mounth)
- Well-being will be assessed by the WHO-5 Well-being Index(15 mounth)
- Blood pressure(15 mounth)
- Urine albumine/creatinine ratio(15 mounth)
- Mortality(15 mounth)
研究者
Annesofie Lunde Jensen
Clinical nursespecialist postdoc
Aarhus University Hospital