Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being (NCT06999486) | Clinical Trial Compass
CompletedNot Applicable
Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being
Spain108 participantsStarted 2025-05-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was focused on caregivers of people with Type 1 diabetes — since it's already completed, could you tell me if there are published results showing whether this computerized tool reliably measured caregiver well-being, and whether those findings might change how our care team supports family members in our situation?
2Since this study was measuring things like distress, mood, and emotional outcomes in caregivers rather than testing a treatment, does that mean there are no direct medical risks to discuss — and is there any chance this kind of assessment tool might be used in our clinic to check on how I'm coping as a caregiver?
3Now that this trial is completed, do you know if the CAT (computerized adaptive test) it validated is being used anywhere in real clinical care for families managing Type 1 diabetes, and could it be something worth trying in our case to track caregiver stress over time?
4Given that this study focused on caregiver well-being rather than the patient's diabetes management directly, what resources or screening tools do you currently have available to support caregivers like me, and could the findings from this kind of research eventually improve those options?
5Since the trial is done and focused on validating a measurement tool rather than a treatment, are there other active studies or programs you're aware of that go a step further and actually offer support interventions for caregivers of people with Type 1 diabetes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Validity and reliability of the CAT system - Emotional outcome 1
Timeframe: Day 1 to Day 15 (Week 2)
2
Validity and reliability of the CAT system - Emotional outcome 2
Timeframe: Day 1 to Day 15 (Week 2)
3
Validity and reliability of the CAT system - Emotional outcome 3
Timeframe: Day 1 to Day 15 (Week 2)
4
Validity and reliability of the CAT system - Mood assessment
Timeframe: Day 1 to day 15 (Week 2)
5
Validity and reliability of the CAT system - Distress Assessment
Timeframe: Day 1 to Day 15 (Week 2)
6
Validity and reliability of the CAT system - Emotional outcome 4