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Completed

NCT Number: NCT06999486

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

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.

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Key information

Conditions

T1D Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAT well-being test

Other

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).

Primary outcomes

  1. Validity and reliability of the CAT system - Emotional outcome 1

    Time frame: 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).

  2. Validity and reliability of the CAT system - Emotional outcome 2

    Time frame: 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).

  3. Validity and reliability of the CAT system - Emotional outcome 3

    Time frame: 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.

  4. Validity and reliability of the CAT system - Mood assessment

    Time frame: 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.

  5. Validity and reliability of the CAT system - Distress Assessment

    Time frame: 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.

  6. Validity and reliability of the CAT system - Emotional outcome 4

    Time frame: 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.

Secondary outcomes

  1. Usability and acceptability of the CAT

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Adhera Health, Inc.

Industry

Collaborators

  • Hospital Miguel Servet

Registry information

Official study title

NEW METHODOLOGIES FOR CUSTOMISING SUPPORT FOR FAMILIES OF CHILDREN WITH DIABETES: Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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