Development and Evaluation of a Low Intensity, Multifaceted, Digital Health Intervention to Prevent Type 2 Diabetes Mellitus in the Primary Care Setting: the PREDIABETEXT Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 365
- 试验地点
- 2
- 主要终点
- Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months
研究概览
简要总结
The aim of this study is to develop and evaluate a low intensity, multifaceted, digital health intervention to prevent T2DM based on: i) the use of a system comprising mobile health (mHealth) technology integrated with electronic health records to send tailored text messages (SMSs) promoting lifestyle changes in people at risk of T2DM, and, ii) the provision of online education to primary healthcare workers about prediabetes management.
详细描述
The PREDIABETEXT project will involve five WorkPackages (WP). In WP1-4 we will develop and pilot-test the different components of the intervention (WP1 will develop the brief text messages targeted to patients; WP2 will adapt our existing technology system to deliver the messages; WP3 will develop an educational intervention targeted to Primary Healthcare workers, and; WP4 will pilot-test and optimise both interventions). In WP5 we will conduct a phase II, six-month, three-arm, cluster randomised, clinical trial with 42 primary care workers and 420 patients at risk of T2DM (HbA1c from 6% to 6.4% or fasting plasma glucose 110-125mg/dl, or both) registered in Primary Care centres from Mallorca. Patients will be allocated to a control (usual care) group, intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare workers). The primary outcome will be HbA1c. Secondary outcomes will include additional clinical outcomes, and physiological, behavioural and psychological outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ELIGIBILITY CRITERIA FOR PRIMARY HEALTHCARE WORKERS:
- •We will include physicians and nurses from primary care centres in Mallorca. We will exclude those anticipating moving to a different centre during the study period.
- •ELIGIBILITY CRITERIA FOR PATIENTS:
- •Inclusion Criteria:
- •Registered in the Public Health Service of the Balearic Islands
- •At risk of T2DM (HbA1c from 6% to 6.4% within the last 3 months or two consecutive values of fasting plasma glucose 110-125mg/dl within the last 12 months, or both)
- •With access to a mobile device able to receive text messages.
排除标准
- •People not able to read messages in Spanish
- •Patients with severe mental conditions.
- •Patients on an antidiabetic medication regime
- •Pregnancy: currently or during the previous 12 months
- •People planning to change healthcare centre during the intervention period
结局指标
主要结局
Change from Baseline Glycated Hemoglobin (HbA1C) at 6 months
时间窗: Baseline and Postintervention (6 months)
次要结局
- Change from Baseline high density cholesterol (HDL) at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Triglycerides at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Total Cholesterol at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Fasting blood glucose at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline lipoprotein A at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline aspartate aminotransferase enzyme (AST) at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline alanine aminotransferase (ALT) at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Waist Circumference at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline of Cardiovascular disease risk at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline low density cholesterol (LDL) at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline urinary sediment at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Blood Pressure at 6 months(Baseline and Postintervention (6 months))
- Quantification of alcohol consumption - FISTERRA(Baseline and Postintervention (6 months))
- Change from Baseline complete hemogram at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline albumin-craetinine ratio at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline Body Weight at 6 months(Baseline and Postintervention (6 months))
- Diagnosis of T2DM(Postintervention (6 months))
- REGICOR Short form Physical Activity Questionnaire(Baseline and Postintervention (6 months))
- Change from Baseline gamma glutamil transpeptidase (GGT) at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline creatinine at 6 months(Baseline and Postintervention (6 months))
- Change from Baseline serum albumin at 6 months(Baseline and Postintervention (6 months))
- Brief motivation questionnaire (ad hoc)(Baseline and Postintervention (6 months))
- Change from Baseline insuline at 6 months(Baseline and Postintervention (6 months))
- 14-point Mediterranean diet adherence screener (MEDAS-14)(Baseline and Postintervention (6 months))
- Spanish version of the physical activity questionnaire used in the Physical activity questionnaire from the Nurses' Health Study(Baseline and Postintervention (6 months))
- Global Adult Tobbacco Survey: GATS questionnaire.(Baseline and Postintervention (6 months))