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临床试验/NCT05648383
NCT05648383已完成不适用

An Intersectoral Innovative Solution Involving DIGItal Tools, Empowering Families and Integrating Community CARE Services for the Prevention and Management of Type 2 Diabetes and Hypertension

Harokopio University8 个研究点 分布在 4 个国家目标入组 1,215 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,215
试验地点
8
主要终点
Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)

研究概览

简要总结

The goal of this hybrid type II effectiveness-implementation trial is to evaluate whether an intersectoral, digitally enabled, family-based intervention can prevent and manage type 2 diabetes mellitus (T2DM) and hypertension (HTN) in adults with intermediate hyperglycaemia or T2DM (with or without HTN), and improve growth outcomes in their children, across socioeconomically diverse communities in Albania, Bulgaria, Greece, and Spain.

The main questions it aims to answer are:

  • Does the DigiCare4You intervention reduce HbA1c levels in adults with T2DM compared to enhanced standard care?
  • Does the DigiCare4You intervention reduce fasting plasma glucose levels in adults with intermediate hyperglycaemia compared to enhanced standard care?
  • Does the DigiCare4You intervention improve BMI z-scores in children linked to enrolled parents compared to enhanced standard care?

Researchers will compare the DigiCare4You intervention group to the enhanced standard care group to see if combining structured counselling, digital self-management tools, and school/community reinforcement improves cardiometabolic outcomes in adults and growth outcomes in children beyond standard national guideline-based care.

Participants will:

  • Complete a two-stage screening procedure, including a digital risk questionnaire and a clinical assessment, to confirm eligibility
  • Attend structured assessment visits at regular intervals over 24 months, including anthropometric, biochemical, and blood pressure measurements
  • Receive (intervention group only) three intensive face-to-face counselling sessions in the first eight weeks, followed by ongoing digital self-management support through interoperable mobile health tools
  • Be encouraged to adopt healthier lifestyle behaviours as a family unit throughout the study period.

详细描述

DigiCare4You is an EU-funded (Horizon 2020) hybrid type II effectiveness-implementation study conducted across four European countries: Albania, Bulgaria, Greece, and Spain. The study addresses a critical gap in chronic disease prevention by combining community-based screening with a digitally supported self-management intervention targeting adults at cardiometabolic risk and their families.

Background and rationale Type 2 diabetes mellitus (T2DM) and hypertension (HTN) are among the leading causes of preventable morbidity and mortality in Europe, disproportionately affecting socioeconomically vulnerable populations. Despite their high burden, early detection and sustained management remain inconsistently delivered, particularly among groups with limited engagement in preventive healthcare. DigiCare4You was designed to address this through an equity-focused, scalable model that integrates screening, prevention, and long-term self-management support within existing health and educational infrastructures.

Study design The study uses a cluster-randomised design, with municipalities allocated 1:1 to either the DigiCare4You intervention arm or the enhanced standard care arm. Randomisation at the municipality level was chosen to minimise contamination between participants and to enable delivery through existing local healthcare and school structures.

Screening approach A novel two-stage screening procedure was embedded within existing national child growth monitoring services, using routine interactions between families and health or educational services as entry points to reach parents and caregivers who might otherwise have limited contact with preventive care. Stage 1 involved a digital self-reported risk questionnaire based on the FINDRISC score. Adults scoring ≥10 were referred to Stage 2, which included glycaemic testing, blood pressure measurement, and anthropometric assessment at local healthcare centres. Adults confirmed with intermediate hyperglycaemia or T2DM, with or without HTN, were invited to join the intervention.

Intervention The 24-month intervention combined structured face-to-face counselling with continuous digital self-management support. Counselling was guided by the Transtheoretical Model and incorporated established behaviour change techniques including self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement, delivered through a shared decision-making approach. Three intensive counselling sessions were provided in the first eight weeks, followed by ongoing support through four interoperable digital tools (MetaDieta, MyDiet, MetaClinic, DiaWatch) supporting nutrition counselling, clinical monitoring, and medication adherence. School- and community-based components reinforced healthy behaviours within the broader family environment.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People who have their permanent residence within the prefecture/region of the relevant facility participating in the clinical study.
  • People having children at primary and/ or secondary education.
  • People who are physically and mentally able to provide their informed consent to participate.
  • People with a FINDRISC ≥10
  • People with a fasting plasma glucose (FPG) ≥ 100 mg/dL and /or glycated hemoglobin (HbA1c) ≥ 5.7%

排除标准

  • People suffering from a health condition where adherence to the intervention will be contraindicated or improbable.
  • People unable to express a free and informed consent for medical and/or psychological conditions, mental incapacity.

结局指标

主要结局

Change from Baseline in fasting plasma glucose [FPG] at 12 months (1st follow-up)

时间窗: Baseline and 12 months (1st follow-up)

Fasting plasma glucose \[FPG\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.

Change from Baseline in fasting plasma glucose [FPG] at 24 months (2nd follow-up)

时间窗: Baseline and 24 months (2nd follow-up)

Fasting plasma glucose \[FPG\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.

Change from Baseline in glycated hemoglobin [HbA1c] at 12 months (1st follow-up)

时间窗: Baseline and 12 months (1st follow-up)

Glycated hemoglobin \[HbA1c\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 12 months (1st follow-up) from baseline.

Change from Baseline in glycated hemoglobin [HbA1c] at 24 months (2nd follow-up)

时间窗: Baseline and 24 months (2nd follow-up)

Glycated hemoglobin \[HbA1c\] is measured in participants with T2DM and in participants with intermediate hyperglycaemia at 24 months (2nd follow-up) from baseline.

次要结局

  • Change from Baseline in blood pressure [BP] at 12 months (1st follow-up)(Baseline and 12 months (1st follow-up))
  • Change from Baseline in blood pressure [BP] at 24 months (2nd follow-up)(Baseline and 24 months (2nd follow-up))
  • Change from Baseline in body weight [BW] at 12 months (1st follow-up)(Baseline and 12 months (1st follow-up))
  • Change from Baseline in body weight [BW] at 24 months (2nd follow-up)(Baseline and 24 months (2nd follow-up))
  • Change from Baseline in waist circumference [WC] at 12 months (1st follow-up)(Baseline and 12 months (1st follow-up))
  • Change from Baseline in waist circumference [WC] at 24 months (2nd follow-up)(Baseline and 24 months (2nd follow-up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yannis Manios

Professor

Harokopio University

研究点 (8)

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