Digital Health for Caregivers Emotional and Self-management Support (CARING)

Adhera Health

Status: Completed

Conditions: Emotional Adjustment; Mood Disturbance

Treatments: Behavioral: mHealth solution based on emotional and behavioral change techniques

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04812665

CAR-0220

Details and patient eligibility

About

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).

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

65 participants in 2 patient groups

Qualitative sub-study (SS1)

Description:

One group of caregivers (n = 10) will engage with the mHealth solution during 1 month. Subsequently, an individual semi-structured interview with each of the participants will proceed to gather user experience qualitative information.

Treatment:

Behavioral: mHealth solution based on emotional and behavioral change techniques

Quantitative sub-study (SS2)

Description:

A different group of caregivers (n = 55) will engage with the mHealth solution during 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional, behavioral and growth parameters before and after engaging with the mHealth solution (pre-post design).

Treatment:

Behavioral: mHealth solution based on emotional and behavioral change techniques