Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being

Recruiting

• Conditions: T1D

• Registration Number: NCT06999486
• Lead Sponsor: Adhera Health, Inc.

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, we will use a technological system called 'Computerised Adaptive Testing' (CAT), which adapts the questions according to the answers of each participant. This allows us to obtain a more accurate assessment tailored to each person's particular situation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study Start: 2025-05-26
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 - 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.
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. Interpretation: Higher scores indicate better well-being.

Secondary Outcome Measures

Name	Time	Method
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 (Bangor et al., 2008) is a 10-item scale based on a 5-point Likert scale assessing perceived usability.

Trial Locations

Locations (1)

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Aragón, Spain