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Completed

NCT Number: NCT04812665

Digital Health for Caregivers Emotional and Self-management Support

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).

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Key information

Conditions

Emotional Adjustment Mood Disturbance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mHealth solution based on emotional and behavioral change techniques

Behavioral

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.

Other names: Adhera

Primary outcomes

  1. Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution

    Time frame: 1 Month

    A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose

  2. Sub-study 2: Changes on caregiver's positive mood

    Time frame: 3 Months

    Positive subscale of the Positive and Negative Affect Scale (PANAS). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.

Secondary outcomes

  1. Emotional outcome: Changes on caregiver's distress

    Time frame: 3 Months

    Distress assessed with the depression, anxiety, and stress scale (DASS-21). DASS-21 is a self-report questionnaire consisting of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the subscales respectively. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as "high" or "severe".

  2. Emotional outcome: Changes on caregiver's general wellbeing

    Time frame: 3 Months

    Assessed with the short form of the Mental Health Continuum - short form questionnaire (MHC-SF). Total sum scores on the MHC-SF can range from 0 to 70, with higher scores indicating higher levels of well-being.

  3. Emotional outcome: Changes on caregiver's perceived self-efficacy

    Time frame: 3 Months

    Perceived self-efficacy assessment with the General Self-Efficacy Scale (GSE), the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

  4. Health-related Quality of Life (HrQoL): Changes on child's HRQoL

    Time frame: 3 Months

    Children HRQoL assessment with KIDSCREEN-10 index answered by the caregiver as a proxy. The scores ranges between 10 and 50, and are linearly converted into 0-100 scale in which higher scores represent better quality of life.

  5. Health-related Quality of Life (HrQoL): Changes on child's HRQoL

    Time frame: 3 Months

    Child HRQoL assessment with Quality of Life in Short Statured Youth (QoLISSY) questionnaire answered by the caregiver as a proxy. This version has 47 items with a 5-point likert scale each. Total score is linearly transformed into 0 to 100 scores with higher values representing higher HRQOL.

  6. Behavioral outcome: Usability

    Time frame: 3 Months

    mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability.

  7. Behavioral outcome: Treatment adherence

    Time frame: 3 Months

    Adherence to the Growth Hormone treatment (GHt) will be measured with the data collected by the Easypod Connect device.

  8. Growth parameter: height

    Time frame: 6 Months

    Height is a crucial indicator of the growth of children under Growth Hormone therapy. Measures from 6 month before starting the study to the end of the study will be obtained from Patient's Electronic Health Record.

Sponsors and collaborators

Lead sponsor

Adhera Health, Inc.

Industry

Collaborators

  • Hospital Miguel Servet
  • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Registry information

Official study title

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

Acronym: CARING

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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