Clinical trial NCT06999486: Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being
Official title: NEW METHODOLOGIES FOR CUSTOMISING SUPPORT FOR FAMILIES OF CHILDREN WITH DIABETES: Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: T1D
Keywords: Type 1 Diabetes
mhealth
caregiver
CAT
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Miguel Servet
First posted: 2025-05-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary caregivers of a child with T1D from Hospital Universitario Miguel Servet in Zaragoza.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Validity and reliability of the CAT system - Emotional outcome 1
timeFrame: Day 1 to Day 15 (Week 2)
measure: Validity and reliability of the CAT system - Emotional outcome 2
timeFrame: Day 1 to Day 15 (Week 2)
measure: Validity and reliability of the CAT system - Emotional outcome 3
timeFrame: Day 1 to Day 15 (Week 2)
measure: Validity and reliability of the CAT system - Mood assessment
timeFrame: Day 1 to day 15 (Week 2)
measure: Validity and reliability of the CAT system - Distress Assessment
timeFrame: Day 1 to Day 15 (Week 2)
measure: Validity and reliability of the CAT system - Emotional outcome 4
timeFrame: Day 1 to Day 15 (Week 2)
Secondary outcomes:
measure: Usability and acceptability of the CAT
timeFrame: Day 15 (Week 2)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
Study officials:
References:
citation: 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.
citation: 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.