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

NCT06999486 | Completed

• 1 other identifier: RO01
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

T1D

Keywords

Type 1 Diabetes; mhealth; caregiver; CAT

Outcome Measures

Primary Outcomes (6)

• 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).

  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).

  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.

  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.

  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.

  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.

  Day 1 to Day 15 (Week 2)

Secondary Outcomes (1)

• Usability and acceptability of the CAT

  Day 15 (Week 2)

Study Arms (1)

Primary caregivers of a child with T1D

Caregivers who are the primary caregivers of a child with T1D.

Other: CAT well-being test

Interventions

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 caregivers of a child with T1D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary caregivers of a child with T1D from Hospital Universitario Miguel Servet in Zaragoza.

You may qualify if:

• 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.

You may not qualify if:

• Caregivers with significant cognitive or physical impairments preventing study participation.
• Inability to read or understand the Spanish language.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Hospital Miguel Servet: collaborator

Study Sites (1)

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Related Publications (2)

• Silverstein J, Klingensmith G, Copeland K, Plotnick L, Kaufman F, Laffel L, Deeb L, Grey M, Anderson B, Holzmeister LA, Clark N; American Diabetes Association. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care. 2005 Jan;28(1):186-212. doi: 10.2337/diacare.28.1.186. No abstract available.

  PMID: 15616254 BACKGROUND

• Katsarou A, Gudbjornsdottir S, Rawshani A, Dabelea D, Bonifacio E, Anderson BJ, Jacobsen LM, Schatz DA, Lernmark A. Type 1 diabetes mellitus. Nat Rev Dis Primers. 2017 Mar 30;3:17016. doi: 10.1038/nrdp.2017.16.

  PMID: 28358037 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: May 31, 2025
• Study Start: May 26, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)