T1D
Conditions
Keywords
Type 1 Diabetes, mhealth, caregiver, CAT
Brief summary
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.
Interventions
OTHERCAT well-being test
Evaluate the psychometric properties (e.g., reliability, validity) of the Computerized Adaptive Testing (CAT) system for assessing the well-being of caregivers of children with Type 1 Diabetes (T1D).
Sponsors
Hospital Miguel Servet
Adhera Health, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Caregivers with significant cognitive or physical impairments preventing study participation. * Inability to read or understand the Spanish language.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validity and reliability of the CAT system - Emotional outcome 3 | 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 - Emotional outcome 1 | 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 | 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 4 | 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. |
| Validity and reliability of the CAT system - Mood assessment | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability and acceptability of the CAT | Day 15 (Week 2) | Outcome Measure: System Usability Scale (SUS) score. Unit of Measure: SUS score (0-100, higher scores indicate better usability). Description: The System Usability Scale is a 10-item scale based on a 5-point Likert scale assessing perceived usability. |
Countries
Spain
Outcome results
None listed