Promote Health With Digital Tools Among Adults With Type 2 Diabetes/Prediabetes and/or Hypertension
NCT05648383 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 992
Last updated 2022-12-13
Summary
The DigiCare4You project will use digital tools for early screening, prevention and management of type 2 diabetes (T2D) and hypertension (HTN). An implementation study will be conducted, targeting more than 10,000 families in two Middle Income Countries (Albania and Bulgaria) and two High Income Countries (Greece and Spain), considering vulnerable groups. Schools will be used as an entry point to the community. Building on an existing procedure for children's periodic growth assessment, conducted by school nurses or in collaboration with local community health centers, parents/ caregivers will be screened via a non-invasive self-reported digital screening tool. Those identified at high risk for T2D will be referred for glycaemia testing (fasting plasma glucose and glycated hemoglobin, HbA1c), as well as blood pressure (BP) measurements, at local community health centers. Parents/ caregivers confirmed to have pre-diabetes or diabetes (and possibly high BP) will be invited to join a mHealth self-management intervention coordinated by the community healthcare workforce. The goal of this intervention is to involve high-risk adults in the treatment process and decision-making on personalized behavioral goals (e.g. diet, physical activity, smoking, alcohol, medication compliance) that meet their needs, and ultimately improve the health status of parents/caregivers, as well as the lifestyle of the entire family.
Conditions
Interventions
- BEHAVIORAL
-
mHealth intervention
Participants will receive mHealth intervention (mobile apps) and counseling sessions along with standard care
- BEHAVIORAL
-
Standard care
Participants will receive standard care, including lifestyle recommendations.
Sponsors & Collaborators
-
Medical University of Varna
collaborator OTHER -
Centre for Research and Technology Hellas
collaborator OTHER -
University of Medicine, Tirana
collaborator OTHER -
La Trobe University
collaborator OTHER -
National and Kapodistrian University of Athens
collaborator OTHER - collaborator OTHER
-
University Ghent
collaborator OTHER -
Universidad de Zaragoza
collaborator OTHER -
PRIVANOVA SAS
collaborator UNKNOWN - collaborator OTHER
-
METEDA SRL
collaborator UNKNOWN -
Baker Heart and Diabetes Institute
collaborator OTHER -
Sant'Anna School of Advanced Studies
collaborator UNKNOWN -
International Diabetes Federation
collaborator OTHER -
STICHTING INTERNATIONAL FOUNDATION FORINTEGRATED CARE
collaborator UNKNOWN -
EUROPEAN UNION'S HORIZON 2020 RESEARCH AND INNOVATION PROGRAMME (Project Number: 945246)
collaborator UNKNOWN -
Harokopio University
lead OTHER
Principal Investigators
-
Yannis Manios, Professor · Harokopio University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-10-01
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- Albania
- Bulgaria
- Greece
- Spain
Study Locations
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