Study to Evaluate the Digital Health and Lifestyle Tool Developed at the University of Gothenburg
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Change of long-term blood glucose concentration measured as glycated hemoglobin at 3 months
研究概览
简要总结
The overall aim of the study is to evaluate a digital lifestyle intervention that has been developed in an academic setting at the University of Gothenburg, Sweden. The tool is based on self-affirmation theory and has large emphasis on self-reflection to enable sustainable lifestyle changes. The effects of the tool on HbA1c, reflecting long-term blood glucose, will be evaluated in patients with type 2 diabetes. The study will contain two phases. The study consists of a three-month period in which participants are randomly assigned to usual care or access to the intervention tool, followed by an open-label three-year observation period during which participants have access to the tool in addition to ordinary healthcare and are compared with matched controls on usual care.
详细描述
Considerable evidence suggest that lifestyle interventions can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine HbA1c. Modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of "lifestyle as medicine". Despite this, a substantial number of patients with type 2 diabetes (T2D) have difficulties attaining adequate glycemic control.
Lifestyle interventions are often complex and difficult to implement on a large scale. Digital health interventions are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness. Knowledge on how to design interventions aimed at inducing change by promoting motivation and personal engagement, as well as a better understanding of patient interaction with digital health interventions, could help overcome these challenges and inform the development of a novel and effective health support.
The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.
The investigators will test the hypothesis that users of the tool get improved HbA1c relative to baseline as compared with controls on usual care.
Overall study design The study is an investigator-initiated single-center study conducted at Skåne University Hospital, Sweden, and will follow participants over three years.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 2 diabetes at or above 35 years of age
- •Diagnosis of diabetes mellitus was based on prior documentation or treatment with anti-hyperglycemic medication or diagnosed according to the WHO criteria (random plasma glucose >11.1 mmol/L or fasting glucose >7.0 mmol/L or HbA1C ≥6.5%).
- •written informed consent.
排除标准
- •type 1 diabetes, MODY or secondary diabetes
- •conditions or treatments that in the judgement of the Investigator could affect the study evaluation
- •inability to understand written Swedish
- •connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected.
结局指标
主要结局
Change of long-term blood glucose concentration measured as glycated hemoglobin at 3 months
时间窗: 3 months
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at 3 months relative to baseline compared between participants with access to the tool and on usual care.
Change of long-term blood glucose concentration measured as glycated hemoglobin at one year
时间窗: One year of the open-label observation period
Intraindividual change of long-term blood glucose concentration measured as glycated hemoglobin (HbA1c) at one year relative to baseline between participants who use the tool as recommended and matched controls on usual care
次要结局
- Change of long-term blood glucose concentration measured as glycated hemoglobin at three years(Three years of the open-label observation period)
- Body weight(3 months, 1 year and 3 years)
- Insulin resistance(3 months, 1 year and 3 years)
- Physical activity in calories per day(3 years)
- Fasting blood glucose concentration(3 months, 1 year and 3 years)
- Insulin secretion(1 year and 3 years)