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

Adhera Health, Inc.100 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Sub-study 1: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health solution

A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose.

Time frame: 1 Month

Sub-study 2: Changes on caregiver's positive mood

Positive subscale of the Positive and Negative Affect Scale (PANAS). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.

Time frame: 3 Months

Secondary Outcomes

Emotional outcome: Changes on caregiver's distress

Distress assessed with the depression, anxiety, and stress scale (DASS-21). DASS-21 is a self-report questionnaire consisting of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the subscales respectively. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".