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

CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

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.

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).

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.