Digital Health for Caregivers Emotional and Self-management Support
- Conditions
- Mood DisturbanceEmotional Adjustment
- Interventions
- Behavioral: mHealth solution based on emotional and behavioral change techniques
- Registration Number
- NCT04812665
- Lead Sponsor
- Adhera Health, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Quantitative sub-study (SS2) mHealth solution based on emotional and behavioral change techniques 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). Qualitative sub-study (SS1) mHealth solution based on emotional and behavioral change techniques 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.
- Primary Outcome Measures
Name Time Method Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution 1 Month A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose
Sub-study 2: Changes on caregiver's positive mood 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 Outcome Measures
Name Time Method Emotional outcome: Changes on caregiver's perceived self-efficacy 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.
Emotional outcome: Changes on caregiver's general wellbeing 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.
Health-related Quality of Life (HrQoL): Changes on child's HRQoL 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.
Growth parameter: height 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.
Behavioral outcome: Usability 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.
Behavioral outcome: Treatment adherence 3 Months Adherence to the Growth Hormone treatment (GHt) will be measured with the data collected by the Easypod Connect device.
Emotional outcome: Changes on caregiver's distress 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".
Trial Locations
- Locations (1)
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Aragón, Spain