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

No results posted yet for this study

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
  • NYU Langone Health

    collaborator OTHER
  • University Ghent

    collaborator OTHER
  • Universidad de Zaragoza

    collaborator OTHER
  • PRIVANOVA SAS

    collaborator UNKNOWN
  • Monash University

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05648383 on ClinicalTrials.gov