Evaluation of a Biopsychosocial System

Adhera Health, Inc.30 enrolled

Overview

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: * Is the integrated biopsychosocial sensing system feasible to use in real-world conditions over a 2-month period? * Is the system usable and acceptable for caregivers? * How do biopsychosocial factors interact with severe glucose events, and what do these dynamics reveal about caregiver distress during T1D management? Findings from this study will help determine whether the system can support future development of data-driven interventions for families managing pediatric T1D.

Study Type

OBSERVATIONAL

Enrollment

Conditions

T1D Type 1 Diabetes (T1D)Type 1 Diabetes

Interventions

Use of Biopsychosocial Sensing System

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 and currently using CGM, specifically Free-Style Libre 2. * The family should be willing to share their child's CGM data with the Adhera Caring Digital Program®, as well as retrospective CGM data from the previous 2 months prior to joining the study. * The child should have had at least 2 severe glycemic events in the previous month, either hyperglycemic (\>250 mg/dL for more than 2 hours) or hypoglycemic (\<70 mg/dL for more than 15 min). This will be assessed by their pediatric endocrinologist during recruitment. * Caregivers must own a smartphone compatible with the study app. * Willingness and ability to use a smartphone-based sensing system. Exclusion criteria: * Caregivers with significant cognitive or physical impairments preventing study participation. * Inability to read or understand the Spanish language. * Participation in other clinical trials involving psychological or diabetes management interventions.

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: From enrollment to the end of study at month 2

Secondary Outcomes

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.

Time frame: At the end of the study (Month 2)

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)

Time frame: 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)

Time frame: 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: * Personal distress * Teen management distress * Parent/teen relationship distress * Healthcare team distress 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: * -1.9: Little or no distress * 2.0-2.9: Moderate distress * ≥3.0: High distress 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.

Time frame: 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®.

Time frame: 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

Time frame: From enrollment to the end of the study at month 2

Evaluation of a Biopsychosocial System

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes