NEW METHODOLOGIES FOR CUSTOMISING SUPPORT FOR FAMILIES OF CHILDREN WITH DIABETES: Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Validity and reliability of the CAT system - Emotional outcome 1
研究概览
简要总结
The main objective of this project is to test whether a tool (questionnaire) is suitable for assessing how caregivers of children and adolescents with TD1 feel emotionally and psychologically. To do this, the investigators will use a technological system called 'Computerised Adaptive Testing' (CAT), which adapts the questions according to the answers of each participant. This allows the investigators to obtain a more accurate assessment tailored to each person's particular situation.
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
- •Caregivers aged ≥18 years who are the primary caregivers of a child with T1D.
- •The child should be younger than 18 years with a confirmed diagnosis of T1D.
- •Willingness and ability to use a smartphone-based sensing system.
- •Willingness to share retrospective continuous glucose monitoring (CGM) data from the child, specifically from the previous 2 months prior to joining the study.
排除标准
- •Caregivers with significant cognitive or physical impairments preventing study participation.
- •Inability to read or understand the Spanish language.
结局指标
主要结局
Validity and reliability of the CAT system - Emotional outcome 1
时间窗: Day 1 to Day 15 (Week 2)
These tend to be sensitive to change in short-term and will include distress assessed by the Depression Anxiety and Stress Scale (DASS-21) and the distress thermometer. Minimum Value: 0. Maximum Value: 63. Interpretation: Higher scores indicate worse outcomes (greater levels of depression, anxiety, and stress).
Validity and reliability of the CAT system - Emotional outcome 2
时间窗: Day 1 to Day 15 (Week 2)
These tend to be sensitive to change in short-term and will include perceived self-efficacy assessment by the General Self-Efficacy Scale (GSE). Minimum Value: 10. Maximum Value: 40. Interpretation: Higher scores indicate better outcomes (greater self-efficacy).
Validity and reliability of the CAT system - Emotional outcome 3
时间窗: Day 1 to Day 15 (Week 2)
Mental Health Continuum Short Form (MHC-SF): This is a 14-item scale that consists of 3 items measuring emotional well-being, 6 items measuring psychological well-being, and 5 items measuring social well-being. Minimum value: 14 Maximum value: 84. Interpretation: Higher scores indicate greater well-being in each domain.
Validity and reliability of the CAT system - Mood assessment
时间窗: Day 1 to day 15 (Week 2)
Positive and Negative Affect Schedule (PANAS) Unit of Measure: - Positive Affect (PA) score range: 10-50 (higher scores indicate greater positive affect). - Negative Affect (NA) score range: 10-50 (higher scores indicate greater negative affect). Description: PANAS is a self-report questionnaire measuring two dimensions of mood: positive and negative affect.
Validity and reliability of the CAT system - Distress Assessment
时间窗: Day 1 to Day 15 (Week 2)
Distress Thermometer Unit of Measure: Score on a 0-10 scale (higher scores indicate higher distress). Description: The Distress Thermometer is a single-item, self-report tool measuring psychological distress on a 0-10 scale.
Validity and reliability of the CAT system - Emotional outcome 4
时间窗: Day 1 to Day 15 (Week 2)
WHO-5 Well-Being Index: Widely validated index to assess mental well-being. It consists of five statements relating to the past two weeks. Responses are rated on a 6-point scale. Minumum value=0, maximum value= 25. Interpretation: Higher scores indicate better well-being. A raw score below 13 may suggest poor well-being and may warrant further evaluation for depression.
次要结局
- Usability and acceptability of the CAT(Day 15 (Week 2))