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

NCT ID: NCT05483803

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-12-14

Brief 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.

Detailed Description

Objectives:

• Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution.
• Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution.

This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:

• Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information.
• Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Qualitative sub-study 1 group

One group of caregivers (n = 20) will engage with the digital health solution during 1 month.

Group Type: EXPERIMENTAL

Adhera® Caring digital intervention for Type 1 Diabetes

Intervention Type: BEHAVIORAL

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

Quantitative sub-study 2 group

A different group of caregivers (n = 80) will engage with the digital health solution during 3 months.

Group Type: EXPERIMENTAL

Adhera® Caring digital intervention for Type 1 Diabetes

Intervention Type: BEHAVIORAL

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

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Caregiver of patients with type 1 diabetes under 18 years of age.
• Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.
• Patients with continuous glucose monitoring.
• Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)
• Participants administering insulin treatment to their children
• Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.
• Participants must agree on sharing data on continuous glucose monitoring data of their treated children.
• Participants must sign an informed consent
• Participants must be willing to and install the mobile solution of the study.

Exclusion Criteria

• Candidates without a smartphone or not being able to interact with it.
• Only one legal guardian per child can participate in the study.
• Participants of SS1 will not take part in SS2.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Miguel Servet

OTHER

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Adhera Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio de Arriba Muñoz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidad de Endocrinología Pediátrica, Hospital Miguel Servet

Luis Fernandez Luque, PhD

Role: PRINCIPAL_INVESTIGATOR

Adhera Health, Inc.

Locations

Hospital Miguel Servet

Zaragoza, Aragon, Spain

Countries

Spain

References

Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530.

Reference Type: BACKGROUND

PMID: 32338624 (View on PubMed)

Other Identifiers

U1111-1280-9100

Identifier Type: REGISTRY

Identifier Source: secondary_id

CAR-22-001

Identifier Type: -

Identifier Source: org_study_id