CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sub-study 1: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health 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 mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D).
The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.
详细描述
Objectives:
- Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution.
- Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution.
This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:
- Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information.
- Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregiver of patients with type 1 diabetes under 18 years of age.
- •Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.
- •Patients with continuous glucose monitoring.
- •Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)
- •Participants administering insulin treatment to their children
- •Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.
- •Participants must agree on sharing data on continuous glucose monitoring data of their treated children.
- •Participants must sign an informed consent
- •Participants must be willing to and install the mobile solution of the study.
排除标准
- •Candidates without a smartphone 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: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health 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 general wellbeing(Baseline up to week 12)
- Behavioral outcome: Usability(At week 4 (sub-study 1) or week 12 (sub-study 2))
- Emotional outcome: Changes on caregiver's distress(Baseline up to week 12)
- Emotional outcome: Changes on caregiver's perceived self-efficacy(Baseline up to week 12)
- Health-related Quality of Life (HrQoL): Changes on the child's HRQoL(Baseline up to week 12)
- Knowledge of the disease and its treatment.(Baseline up to week 12)
- Life-style outcome: Adherence to Mediterranean diet(Baseline up to week 12)
- Life-style outcome: physical activity (APALQ)(Baseline up to week 12)
- Behavioral outcome: objectively measured children's metabolic control to the treatment(Baseline up to week 12)