Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes (CARING-T1D)

Adhera Health

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05483803

CAR-22-001

U1111-1280-9100 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Qualitative sub-study 1 group

Experimental group

Description:

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

Treatment:

Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes

Quantitative sub-study 2 group

Experimental group

Description:

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

Treatment:

Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes