The Digital Diabetes Patient Reminder (DIPAR) Tool to Improve Clinical Outcomes and Process of Management in Adults With Type 2 Diabetes: A Proof-of-Concept Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Documentation rate of Albuminuria
研究概览
简要总结
Digital health tools may present an opportunity to address these challenges by enhancing care delivery, improving patient engagement, and facilitating better disease management for chronic diseases such as type 2 diabetes mellitus (T2DM). This primary objective of this randomized controlled trial is to evaluate whether the Diabetes Digital Patient Reminder (DIPAR), embedded in patient portal, can increase the proportion of T2DM patients who have their albuminuria measured at least once annually by either a general practitioner (GP) or a diabetes specialist, as documented in their hospital medical records (EMD), thereby reflecting active monitoring of diabetes-related parameters.
详细描述
The purpose of this study is to evaluate the effectiveness of the DIPAR digital tool in improving the management process of patients with type 2 diabetes mellitus (T2DM).
The DIPAR tool consists of two core functionalities designed to support diabetes management: a reminder function and a consultation dashboard.
- Reminder Function The reminder feature aims to encourage timely diabetes-related clinical follow-ups. It provides patients with automated notifications through the MyNexuzhealth patient portal, usually installed in the mobile phones of the patients, when their measurements for HbA1c and Albuminuria are overdue. These reminders align with the minimal follow-up requirements in Belgium, where HbA1c must be measured biannually and albuminuria annually. We hypothesize that these reminders will prompt patients to schedule routine clinical follow-ups with their general practitioner or diabetes specialist.
Notification schedule
- HbA1c: First reminder after 7 months without a measurement; second reminder 4 weeks later if still overdue.
- Albuminuria: First reminder after 13 months without a measurement; second reminder 4 weeks later if still overdue.
- Consultation Dashboard
The consultation dashboard will be provided study participants at the participating institution and will display the following relevant clinical data, extracted from the medical dossier of the diabetes specialist in a visual and colourful display of the progress over time:
- Clinical outcomes: HbA1c (%), LDL-C (mg/dl), systolic and diastolic blood pressure (mmHg), albuminuria (mg/gACR), eGFR (ml/min/1.73m2) and BMI (weight/lenght2)
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
- Single (Outcomes Assessor)
盲法说明
Randomization will be carried out by an external person to the study and the data will be analyzed by an external extension
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
- •Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures;
- •Adults 18 years or older;
- •Treated and followed-up for Type 2 diabetes at the department of endocrinology at the participating hospitals;
- •Patients with (the ability to access) the MyNexuz patient portal;
- •Patients with the ability to understand Dutch, French or English.
排除标准
- •Participant is pregnant or hospitalized at the time of recruitment;
- •Are unable to use a mobile phone because of mental or cognitive impairment;
- •Deemed ineligible by the treating physicians.
研究组 & 干预措施
DIPAR Intervention Group
Standard of Care and the Digital DIPAR Intervention (reminder function + consultation dashboard)
干预措施: Digital Diabetes Patient Reminder Tool (Device)
DIPAR Intervention Group
Standard of Care and the Digital DIPAR Intervention (reminder function + consultation dashboard)
干预措施: Standard of Care treatment and follow-up (Other)
Control Group
Standard of Care
干预措施: Standard of Care treatment and follow-up (Other)
结局指标
主要结局
Documentation rate of Albuminuria
时间窗: 12 months post intervention
Defining the proportion of patients with at least one measured and documented albuminuria value in the electronic medical dossier
次要结局
- Documentation rate of HbA1c (2x)(12 month post intervention)
- Documentation rate of HbA1c (1x)(12 month post intervention)
- DIPAR Usability(12 months post intervention)
- DIPAR Acceptability(12 months post intervention)
- Change in HbA1c(Baseline, Month 6 and Month 12 post intervention)
- Change in Albuminuria(Baseline, Month 6 and Month 12 post intervention)
- Change in Cholesterol(Baseline, Month 6 and Month 12 post intervention)
- Change in Blood Pressure(Baseline, Month 6 and Month 12 post intervention)
- Change in Weight(Baseline, Month 6 and Month 12 post intervention)
- Change in Heart rate(Baseline, Month 6 and Month 12 post intervention)