At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating mHealth self-management intervention and Standard care for Type 2 Diabetes and 3 related conditions. Completed, enrolled 1,215 participants across 4 sites in 4 countries.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Participants will receive the mHealth intervention (use of mobile apps) and counseling sessions along with enhanced standard care
Participants will receive enhanced standard care, including lifestyle recommendations
Participants will receive enhanced standard care, including lifestyle recommendations
Interventions
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).
Participants will receive standard care, including lifestyle recommendations.