Digital health for emotional and self-management support of caregivers of children receiving growth hormone treatment: a feasibility study protocol

Sergio Cervera-Torres, Francisco José Núñez-Benjumea, Antonio de Arriba Muñoz, Irene Alice Chicchi Giglioli, Luis Fernández-Luque, Sergio Cervera-Torres, Francisco José Núñez-Benjumea, Antonio de Arriba Muñoz, Irene Alice Chicchi Giglioli, Luis Fernández-Luque

Abstract

Background: Caregivers of children undergoing growth hormone treatment often face stress and stigma. In this regard, family-centered approaches are increasingly considered, wherein caregivers' mental wellbeing is taken into account to optimize children's health-related outcomes and behaviors (e.g., treatment adherence). Here, mindfulness and parenting-based programs have been developed to support the mental wellbeing of caregivers and, in turn, promote richer interactions with the children. Nevertheless, this type of program can face drawbacks, such as the scheduling and availability of family members. Recent digital health (DH) solutions (e.g., mobile apps) are showing promising advantages as self-management support tools for improving wellbeing and behaviors related to the treatments. Although, further evidence is necessary in the field of Growth Hormone Treatment (GHt). Accordingly, this study aims to examine the usability of a mobile DH solution and the feasibility of a DH intervention designed to promote emotional and mental wellbeing of caregivers of children undergoing GHt.

Methods: This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies, including caregivers of children undergoing GHt. Sub-study one (SS1; n = 10) focuses on the usability of the DH solution (detecting potential barriers and facilitators) and an ad hoc semi-structured interview will be administered to the caregivers after using the DH solution for one month. Sub-study two (SS2; n = 55) aims to evaluate the feasibility of the DH intervention on caregivers' perceived distress, positive affectivity, mental wellbeing, self-efficacy, together with the children's quality of life and treatment adherence. All these parameters will be assessed via quantitative methods before and after 3-months of the DH intervention. Usability and engagement will also be assessed during and at the end of the study.

Results: It is expected that significant amounts of data will be captured with regards of the feasibility of the DH solution.

Discussion: The manuscript provides a complete protocol for a study that will include qualitative and quantitative information about, on one hand, the user-friendliness of the DH solution, and on the other, the effects on caregivers' emotional, as well as, behavioral parameters in terms of the usability and engagement to the DH solution. The findings will contribute to the evidence planning process for the future adoption of digital health solutions for caregiver support and better health-related outcomes. Trial registration ClinicalTrials.gov, ID: NCT04812665.

Keywords: Caregiver; Emotional wellbeing; Family-centered approach; Growth hormone; Pediatric endocrinology; mHealth.

Conflict of interest statement

LFL, SCT, FJNB and IACG are employee of Adhera Health Inc., which is a Precision Digital Companion™ company based in Palo Alto (CA, USA). LFL is a shareholder of Adhera Health Inc.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Adhera Caring: psychoeducational modules
Fig. 2
Fig. 2
Adhera Caring: The quiz unit (gamification element) with the explanation of the answer
Fig. 3
Fig. 3
Adhera Caring: Motivational messages and ratings
Fig. 4
Fig. 4
Mental Wellbeing activities and emotional pre-and post-evaluation
Fig. 5
Fig. 5
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). Schedule of enrollment, interventions, and assessments planned in the study

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