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

NCT ID: NCT06999486

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-26

Study Completion Date

2025-08-13

Brief Summary

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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.

Detailed Description

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Conditions

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T1D

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary caregivers of a child with T1D

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

CAT well-being test

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Miguel Servet

OTHER

Sponsor Role collaborator

Adhera Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 15616254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28358037 (View on PubMed)

Other Identifiers

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RO01

Identifier Type: -

Identifier Source: org_study_id

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