Digital Health for Caregivers Emotional and Self-management Support

Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children Receiving Growth Hormone Treatment

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a novel mobile Health (mHealth) solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children undergoing Growth Hormone treatment (GHt).

This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a novel mobile Health (mHealth) solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children undergoing Growth Hormone treatment (GHt).

Primary Objectives:

• To gather qualitative information enabling to better understand individualized experiences of caregiving children undergoing GHt and perceived barriers/facilitators for adoption of the mHealth solution.
• To assess positive mood states of caregivers of GHt patients as an indicator of emotional wellbeing related to the use of the mHealth solution.

Secondary Objectives:

To explore whether the mHealth solution applied to caregivers of children undergoing GHt might affect:

• Broader emotion-related parameters: Distress (emotional disturbance), self-efficacy (perceived own capability of managing stress), and general psychological wellbeing of caregivers.
• Perceived Health-related quality of life (HRQoL) of children (evaluated from the caregivers' perspective).
• Behavioral parameters: Usability / engagement with the mHealth solution and children's adherence to treatment measured by Easypod-Connect.
• Growth parameters: height of the child.

The study targets caregivers of GHt patients.

Inclusion Criteria:

• Adherence to GHt monitored in the last month prior enrollment indicates a ratio less than 85%.
• Legal guardian of children who receive GHt in accordance with approved indications in Spain.
• Explicit agreement on data sharing regarding adherence to GHt gathered through the Easypod Connect.
• Participants must be able to interact with a smart phone and willing to install the mHealth solution of the study in their smart phone.
• Participants must sign the specific informed consent form for the study.

Exclusion Criteria:

• Candidates without an smart phone 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.