Clinical trial NCT04812665: Digital Health for Caregivers Emotional and Self-management Support
Official title: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children Receiving Growth Hormone Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emotional Adjustment
Mood Disturbance
Keywords: Emotional Adjustment
Mood Disturbance
Behavioral Intervention
mHealth
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Miguel Servet
name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2021-03-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample of the study (caregivers) will be recruited from the Pediatric Endocrinology unit at the Miguel Servet Children's University Hospital. This public hospital provides pediatric healthcare delivery to the regional area of Zaragoza (Spain), which covers a total of 367.110 inhabitants.

Participants will sign an informed consent during routine clinical visits to the centers. For accessing treatment adherence data (Easypod-Connect) of children aged 12 y.o. and over, a specific Informed Consent Form (ICF) will also need to be signed by the minor according to the Spanish regulation, jointly with the legal guardian's one.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution
timeFrame: 1 Month
measure: Sub-study 2: Changes on caregiver's positive mood
timeFrame: 3 Months
Secondary outcomes:
measure: Emotional outcome: Changes on caregiver's distress
timeFrame: 3 Months
measure: Emotional outcome: Changes on caregiver's general wellbeing
timeFrame: 3 Months
measure: Emotional outcome: Changes on caregiver's perceived self-efficacy
timeFrame: 3 Months
measure: Health-related Quality of Life (HrQoL): Changes on child's HRQoL
timeFrame: 3 Months
measure: Health-related Quality of Life (HrQoL): Changes on child's HRQoL
timeFrame: 3 Months
measure: Behavioral outcome: Usability
timeFrame: 3 Months
measure: Behavioral outcome: Treatment adherence
timeFrame: 3 Months
measure: Growth parameter: height
timeFrame: 6 Months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
Study officials:
affiliation: Adhera Health, Inc.
name: Luis Fernández-Luque, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Cervera-Torres S, Nunez-Benjumea FJ, de Arriba Munoz A, Chicchi Giglioli IA, Fernandez-Luque L. Digital health for emotional and self-management support of caregivers of children receiving growth hormone treatment: a feasibility study protocol. BMC Med Inform Decis Mak. 2022 Aug 13;22(1):215. doi: 10.1186/s12911-022-01935-1.
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