Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children Receiving Growth Hormone Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Sub-study 1: Psychological burdens experienced as caregivers of children receiving GHt and barriers/facilitators for adopting the mHealth solution
时间窗: 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
时间窗: 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.
次要结局
- Emotional outcome: Changes on caregiver's perceived self-efficacy(3 Months)
- Emotional outcome: Changes on caregiver's general wellbeing(3 Months)
- Health-related Quality of Life (HrQoL): Changes on child's HRQoL(3 Months)
- Growth parameter: height(6 Months)
- Behavioral outcome: Usability(3 Months)
- Behavioral outcome: Treatment adherence(3 Months)
- Emotional outcome: Changes on caregiver's distress(3 Months)