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| Name | Class |
|---|---|
| Hospital Universitario Miguel Servet, Zaragoza | UNKNOWN |
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The goal of this observational study is to evaluate the feasibility of a biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for caregivers of children with type 1 diabetes (T1D). The main questions it aims to answer are:
Findings from this study will help determine whether the system can support future development of data-driven interventions for families managing pediatric T1D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary caregivers of a child with T1D | This cohort includes caregivers of children with type 1 diabetes who will use the biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for 2 months. No interventions are administered; caregivers use the system as part of this observational feasibility study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Biopsychosocial Sensing System | Other | Participants use a biopsychosocial sensing system integrated into the Adhera Caring Digital Program® for a 2-month period. The system collects caregiver emotional well-being data through computer adaptive testing (CAT) and ecological momentary assessment (EMA), along with children's CGM data. This is an observational study and no treatment or behavioral intervention is administered. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Biopsychosocial Sensing System | Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including: - Response rate to Ecological Momentary Assessment (EMA) prompts | From enrollment to the end of study at month 2 |
| Feasibility of the Biopsychosocial Sensing System | Feasibility will be assessed using metrics from the Adhera Caring Digital Program®, including: - Completion rates of scheduled CAT assessments | From enrollment to the end of study at month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability and acceptability of the system | 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. | At the end of the study (Month 2) |
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Inclusion criteria:
Exclusion criteria:
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The study population consists of caregivers of children with type 1 diabetes recruited from Hospital Miguel Servet in Spain. Eligible caregivers are adults who serve as the primary caregiver for a child under 18 years old with a confirmed diagnosis of T1D and who uses the FreeStyle Libre 2 continuous glucose monitoring system. Families must be willing to share the child's CGM data and have experienced at least two severe glucose events in the previous month. Caregivers must own a compatible smartphone and be able to use a mobile sensing system. Exclusion criteria include significant cognitive or physical impairments, inability to read or understand Spanish, or participation in other clinical trials involving psychological or diabetes-related interventions.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Miguel Servet | Zaragoza | Aragon | 50009 | Spain |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Caregiver Distress Measured by Ecological Momentary Assessment (EMA) |
Caregiver distress will be measured using Ecological Momentary Assessment (EMA) delivered via smartphone. Distress will be quantified using EMA distress scores reported in response to daily prompts. Unit of Measure: EMA distress score (continuous scale) |
| From enrollment to the end of the study at month 2 |
| Caregiver Distress Measured by Computer Adaptive Testing (CAT) | Caregiver distress will be assessed using Computer Adaptive Testing (CAT) administered electronically. Distress will be quantified using CAT-generated distress scores. Unit of Measure: CAT distress score (continuous scale) | From enrollment to the end of the study at month 2 |
| Psychosocial Patterns and Caregiver Responses to Glucose Events - Caregiver Distress (Parent Diabetes Distress Scale) | Caregiver distress will be measured using the Parent Diabetes Distress Scale (Parent-DDS), a 20-item questionnaire assessing four subscales:
Scoring: For each scale and the total score, responses are summed and divided by the number of items in that scale, yielding a mean item score ranging from 0 to 5. Interpretation of scores:
Higher scores indicate greater caregiver distress. Associations between Parent-DDS scores (total and subscale scores) and children's severe glucose events (hyperglycemia >250 mg/dL for >2 hours or hypoglycemia <70 mg/dL for >15 minutes) will be analyzed. Clinicians may consider moderate or high distress worthy of clinical attention depending on context. | From enrollment to the end of the study at month 2 |
| Mobile Application Engagement | Engagement will be quantified using app logs and user profiling, including frequency and duration of interactions with the Adhera Caring Digital Program®. | From enrollment to the end of study at month 2 |
| Frequency of Severe Glucose Events in Children | Outcome Measure Description Severe glucose events will be defined as hyperglycemia >250 mg/dL for more than 2 hours or hypoglycemia <70 mg/dL for more than 15 minutes, as measured by continuous glucose monitoring. Unit of Measure Number of severe glucose events. Higher number, worse outcome | From enrollment to the end of the study at month 2 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |