An observational study in T1D, sponsored by Adhera Health, Inc.. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Adhera Health, Inc. · Observational
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 108 is close to the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Adhera Health, Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Primary caregivers of a child with T1D from Hospital Universitario Miguel Servet in Zaragoza.
Exclusion Criteria:
Caregivers who are the primary caregivers of a child with T1D.
Other: CAT 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).
Validity and reliability of the CAT system - Emotional outcome 1
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).
Time frame: Day 1 to Day 15 (Week 2)
Validity and reliability of the CAT system - Emotional outcome 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).
Time frame: Day 1 to Day 15 (Week 2)
Validity and reliability of the CAT system - Emotional outcome 3
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.
Time frame: Day 1 to Day 15 (Week 2)
Validity and reliability of the CAT system - Mood assessment
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.
Time frame: Day 1 to day 15 (Week 2)
Validity and reliability of the CAT system - Distress Assessment
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.
Time frame: Day 1 to Day 15 (Week 2)
Validity and reliability of the CAT system - Emotional outcome 4
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.
Time frame: Day 1 to Day 15 (Week 2)
Usability and acceptability of the CAT
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.
Time frame: Day 15 (Week 2)
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Adhera Health, Inc.