Clinical Research Directory
Browse clinical research sites, groups, and studies.
Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
Sponsor: Harokopio University
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1215
Start Date
2022-10-01
Completion Date
2025-12-20
Last Updated
2026-06-09
Healthy Volunteers
Yes
Interventions
mHealth self-management intervention
A 24-month mHealth self-management intervention combining structured face-to-face counselling (n=5-7) with continuous digital support. Counselling follows the Transtheoretical Model, incorporating self-monitoring, goal setting, barrier problem solving, relapse prevention, and self-efficacy enhancement via shared decision-making. Three additional intensive sessions are delivered in weeks 2, 4, and 8, followed by ongoing support through four interoperable digital tools, supporting nutrition counselling, clinical monitoring, blood glucose and blood pressure self-monitoring, and medication adherence. Delivery is by multidisciplinary primary care teams using standardised operating procedures. Intervention intensity and visit schedules differ by metabolic subgroup (intermediate hyperglycaemia vs T2DM).
Standard care
Participants will receive standard care, including lifestyle recommendations.
Locations (4)
Universiteti i Mjekësisë
Tirana, Rruga E Dibrës, Albania
Medical University of Varna
Varna, Varna, Bulgaria
Harokopio University
Athens, Attica, Greece
Universidad de Zaragoza
Zaragoza, Zaragoza, Spain