Using the Support Online Platform for Self-management Education of Adults Living With Type 1 Diabetes as Part of Usual Care or Independently: an Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 322
- 试验地点
- 8
- 主要终点
- Self-efficacy for diabetes management
研究概览
简要总结
The investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes (T1D) in their diabetes self-management. Investigators will compare a group that has access to the "Support" platform through their usual medical care to a group that accesses the platform independently. The first group will be recruited through four participating clinics in the province of Quebec (Canada). The second group will be composed of adults living with T1D across Canada. Participants will have access to the platform for 12 months and will be asked to complete online questionnaires at the beginning and after 6 and 12 months, and share their glucose reader data with the research team. A subgroup of participants as well as healthcare professionals from the four clinics will be invited to participate in an individual interview aiming to understand the barriers and facilitators of integration "Support" in clinical care.
详细描述
Type 1 diabetes (T1D) is a chronic condition which requires life-sustaining insulin therapy as well as knowledge, skills and confidence to self-manage. Tailored diabetes self-management education (DSME) should be offered to all people living with diabetes (PWT1D) at diagnosis, but also in a timely manner according to needs. DSME has the potential to improve quality of life and decrease diabetes complications. Despite the positive outcomes of other DSME programs, participation rates of DSME vary greatly perhaps because access remains sub-optimal. Also, healthcare professionals (HCPs) face a challenge to remain aware of the particularities of T1D and stay up-to-date on the rapidly evolving evidence-based knowledge, technologies and therapies available. The investigators propose to examine an online training and peer support platform, called "Support" as a potential alternative for DSME.
The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the "Support" platform to routine medical care of adults living with T1D (i.e., diabetes team referring to the "Support" platform during appointments) can improve diabetes self- management, in comparison with navigating the "Support" platform independently of usual care (i.e., the platform not being discussed during appointment) (Effectiveness), and to study the factors affecting its implementation in real-life settings (Implementation).
This study is a mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial.
ARM 1: PWT1D participants will have access to Support as part of their regular care (their HCPs will use "Support" in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid.
ARM 2: PWT1D participants will have access to "Support", independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Diagnosis of T1D (including LADA - latent autoimmune diabetes in adults)
- •Have access to Internet
- •Use of an active email address
- •Comprehension of English or French
- •Live in Canada
排除标准
- •- Unable to use the Support platform
结局指标
主要结局
Self-efficacy for diabetes management
时间窗: 0, 6 and 12 months
Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)
次要结局
- Diabetic Ketoacidosis (DKA) events(0, 6 and 12 months)
- Well-being(0, 6 and 12 months)
- Continuous Glucose Monitoring (CGM) - % Time in range(0, 6 and 12 months)
- Continuous Glucose Monitoring (CGM) - % Time above range(0, 6 and 12 months)
- Cost effectiveness (self-efficacy)(6 and 12 months)
- Continuous Glucose Monitoring (CGM) - % Time below range(0, 6 and 12 months)
- Hemoglobin A1c(0, 6 and 12 months)
- Severe hypoglycemic events(0, 6 and 12 months)
- Continuous Glucose Monitoring (CGM) - Standard deviation(0, 6 and 12 months)
- Continuous Glucose Monitoring (CGM) - % Coefficient of variation(0, 6 and 12 months)
- calls to 911(0, 6 and 12 months)
- calls to 811(0, 6 and 12 months)
- Cost effectiveness (HbA1c)(6 and 12 months)
研究者
Anne-Sophie Brazeau
Associate Professor
McGill University