Protocol for the Digital, Individualized, and Collaborative Treatment of Type 2 Diabetes in General Practice Based on Decision Aid (DICTA) - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in a binary indicator, composed by a composite endpoint of HbA1c, systolic blood pressure, low-density lipoprotein cholesterol, no smoking, and normal albuminuria
研究概览
简要总结
The purpose of this project is to improve life of patients with type 2 diabetes through an IT-supported lifestyle and treatment intervention.
The intervention is based on combining and adapting existing and effective elements into the IT system of the general practitioner. In this way we will integrate specialist supervised treatment in general practice, individual patient coaching, and improved information exchange and data mining.
The DICTA intervention consists of two integrated components: a patient-directed eHealth lifestyle coaching program delivered via the LIVA application, and a clinician-directed CDS tool embedded into the EPJ system.
- eHealth lifestyle coaching: Individuals with T2D in the intervention group will receive individualized digital coaching from a health coach through the LIVA application. PROs are shared with GPs and health staff via the EPJ, enabling tailored, data-driven lifestyle support.
- CDS: GPs receive real-time, individualized, algorithm-based pharmacological treatment recommendations for managing T2D, hypertension, and hypercholesterolemia, as appropriate.
This is expected to facilitate use, assure individually tailored solutions, optimize treatment effects, and strengthen patient engagement.
The study is a randomized controlled trial (RCT). It will include 400 patients with newly diagnosed type 2 diabetes. The patients will receive either treatment based on the intervention or usual care. After one year, we will assess quality of life and cardiovascular risk factors in both groups and evaluate if one group has improved management of their type 2 diabetes compared to the other.
If the intervention proves effective, implementation on a national scale is highly feasible, and the intervention could probably be adapted to other lifestyle-related chronic diseases in Denmark and in other countries.
详细描述
Background
A study from the UK showed that an intensive intervention comprising a total diet replacement, stepped food reintroduction and structured support for long-term weight loss maintenance resulted in long-term T2D remission for almost half of the patients (Lean et al., 2018).
In Denmark T2D is primarily managed in general practice, but despite intensive focus on T2D, many patients are not treated optimally, nor do they follow the recommendations for healthy lifestyle (Bo A et al, 2018). The Danish Center for Strategic Research in T2D (DD2) was initiated in 2010 with the overall aim of improving the quality of care for newly diagnosed T2D patients. The DD2 data comprises biological samples, as well clinical, lifestyle and quality of life data (Christensen et al, 2018). As of May 2019, DD2 holds samples from over 8,500 incident T2D patients. Based on the DD2 data, a model-intervention on individually tailored treatment of T2D was developed in 2013 and showed to be feasible in general practice (Stidsen et al, 2017).
Further researchers from the DICTA study group have found in a pilot study, a collaborative eHealth tool in a GP setting to induce weight loss among obese patients resulted in a 7 kg weight reduction, which was maintained over a 20-month period (Brandt et al., 2011) and a 5,4 kg weight loss for T2D men after 12 months (Haste et al, 2017). This collaborative eHealth tool(LIVA) has been updated and refined on the basis of input from extensive interviews with patients, healthcare professionals, and GPs (Brandt 2018a, Brandt 2018b and Brandt 2018c) and is in use in several Danish municipalities with promising results (Komkova 2019).
The DICTA project received support from Steno Collaboratory Grants 2018 and 2019 developing a web-based platform for patient registered outcome measurements and lifestyle coaching in collaboration with Liva Healthcare a/s, Cambio Healthcare Systems A/S and CGM A/S. This platform is now integrated in the electronic healthcare record systems used by the majority of Danish GPs (XMO, CGM). The intervention will provide novel, data-driven, individualized support to GPs, and individualized digital data-driven lifestyle support to their T2D patients supported by AI (machine learning) and timely accessible to the GPs when relevant.
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
- Single (Outcomes Assessor)
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
- •Diabetes type 2 in up to 10 years
排除标准
- •Fails to complete the initial questionnaire
- •No Internet access in own home through computer or smart phone
- •Is pregnant or actively trying to get pregnant
- •Has a serious or life-threatening disease
结局指标
主要结局
Change in a binary indicator, composed by a composite endpoint of HbA1c, systolic blood pressure, low-density lipoprotein cholesterol, no smoking, and normal albuminuria
时间窗: 12 months
The primary outcome is the one-year change in estimated ten-year cardiovascular risk assessed by SCORE2-Diabetes calculated from age, smoking status, systolic blood pres-sure, total and high-density lipoprotein cholesterol, age at diabetes diagnosis, HbA1c, and eGFR. As we will be focusing on one-year changes in SCORE2-Diabetes, we do not consider it a problem that SCORE2-Diabetes does not include prevalent cardiovascular disease in the risk calculation as this variable will be constant over the one-year period on almost all of the patients.
Change in a binary indicator, composed by a composite endpoint of HbA1c, systolic blood pressure, low-density lipoprotein cholesterol, no smoking, and normal albuminuria
时间窗: 12 months
The primary outcome is the one-year change in estimated ten-year cardiovascular risk assessed by SCORE2-Diabetes calculated from age, smoking status, systolic blood pres-sure, total and high-density lipoprotein cholesterol, age at diabetes diagnosis, HbA1c, and eGFR. As we will be focusing on one-year changes in SCORE2-Diabetes, we do not consider it a problem that SCORE2-Diabetes does not include prevalent cardiovascular disease in the risk calculation as this variable will be constant over the one-year period on almost all of the patients.
次要结局
- Change in physical activity measured through AX3(12 months)
- Numbers change in level of use of hypertension, hypercholesterolemic and glucose-lowering drugs(12 months)
- Change in level of albuminuria(12 months)
- Change in quality of life measured by European Quality of life - EQ VAS(12 months)
- Change in abdominal circumference to hip circumference(12 months)
- Change in quality of life measured by European Quality of life - 5 Dimensions - 5 level (EQ-5D-5L)(12 months)
- Change in weight(12 months)
- Change in low-density lipoprotein cholesterol(12 months)
- Change in systolic blood pressure(12 months)
- Change in number of patients not smoking,(12 months)
- Change in HbA1c(12 months)