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Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

NCT05483803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-02-01

No results posted yet for this study

Summary

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D).

The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

Adhera® Caring digital intervention for Type 1 Diabetes

The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).

Sponsors & Collaborators

  • Hospital Miguel Servet

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Adhera Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Antonio de Arriba Muñoz, MD, PhD · Unidad de Endocrinología Pediátrica, Hospital Miguel Servet

  • Luis Fernandez Luque, PhD · Adhera Health, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-14
Completion
2023-12-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT05483803 on ClinicalTrials.gov