NCT04812665

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Adhera Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Emotional Adjustment
• Mood Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	mHealth solution based on emotional and behavioral change techniques	Adhera supports the empowerment of patients with chronic conditions by supporting the acquisition of healthier lifestyles, improved mental wellbeing and grounded on the principles of behavioral change. The solution is based on incorporating the principles of personalized health education into a mobile platform which is achieved by applying the Integrated Model of Behavioral Change which is further adapted using recommender systems. Emotional and mental health elements, such as stress, resilience, are crucial part in the acquisition of self-management behaviors and will be the main focus of this intervention. Adhera adapts to provide tailored support to specific users' needs.

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-08-12
• Completion: 2022-08-12
• First posted: 2021-03-24
• Last updated: 2023-03-29

Locations

1 site across 1 country: Spain