Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

Study Overview
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Brief Summary
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This feasibility study builds upon mental health and technology acceptance theoretical frameworks. It seeks to examine potentials of a mobile-based novel digital health solution based on emotional and behavioral change techniques, to provide emotional and self-management tailored support to caregivers of children with type I diabetes (T1D). The digital health program, called Adhera® Caring, is designed to be used for approximately 3 months. The study will enroll 100 participants (20 in sub-study 1 and 80 in sub-study 2) who are caregivers of children with type 1 diabetes. There will be a nurse coaching the participants by providing support related to their emotional wellbeing via the mobile solution.

Detailed Description
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Objectives: Primary objective 1. To gather qualitative and quantitative information enabling to better understand psychological burdens that caregivers of children with type 1 diabetes and perceived barriers/facilitators for adoption of a digital health solution. Primary objective 2. To assess positive mood states of caregivers of type 1 diabetes patients as an indicator of emotional wellbeing related to the use of the digital health solution. This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies: Qualitative sub-study 1 (SS1): One group of caregivers (n = 20) will engage with the digital health solution for 1 month. Subsequently, an individual semi-structured interview with each of the participants and a usability questionnaire will proceed to gather user experience qualitative information. Quantitative sub-study 2 (SS2): A different group of caregivers (n = 80) will engage with the digital health solution for 3 months. As elaborated in the following sections, a quantitative approach will be adopted to assess different emotional and behavioral parameters before and after engaging with the digital health solution (pre-post design).

Official Title
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CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caregiver of patients with type 1 diabetes under 18 years of age. Patient's debut of type 1 diabetes at least 3 months prior to the start of the study. Patients with continuous glucose monitoring. Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion) Participants administering insulin treatment to their children Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain. Participants must agree on sharing data on continuous glucose monitoring data of their treated children. Participants must sign an informed consent Participants must be willing to and install the mobile solution of the study. Exclusion Criteria: Candidates without a smartphone or not being able to interact with it. Only one legal guardian per child can participate in the study. Participants of SS1 will not take part in SS2.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Participants will be enrolled in two sub-studies. Participants in sub-study 1 will be enrolled in an intervention for 1 month. After sub-study 1 completion a new group of participants will be enrolled in the sub-study 2 for the intervention lasting 3 months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qualitative sub-study 1 group<br>One group of caregivers (n = 20) will engage with the digital health solution during 1 month. | Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes<br>* The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).<br>|
| Experimental: Quantitative sub-study 2 group<br>A different group of caregivers (n = 80) will engage with the digital health solution during 3 months. | Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes<br>* The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sub-study 1: Qualitative data of psychological burdens experienced as caregivers of children with type 1 diabetes and barriers/facilitators for adopting the digital health solution | A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose. | 1 Month | 
| Sub-study 2: Changes on caregiver's positive mood | Positive subscale of the Positive and Negative Affect Scale (PANAS). Scores can range from 10-50 for both the Positive and Negative Affect with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect. | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional outcome: Changes on caregiver's distress | Distress assessed with the depression, anxiety, and stress scale (DASS-21). DASS-21 is a self-report questionnaire consisting of 21 items, 7 items per subscale: depression, anxiety and stress. Patients are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much). Sum scores are computed by adding up the scores on the items per (sub)scale and multiplying them by a factor 2. Sum scores for the total DASS-total scale thus range between 0 and 120, and those for each of the subscales may range between 0 and 42. Cut-off scores of 60 and 21 are used for the total DASS score and for the subscales respectively. Scores ≥60 (for DASS-total) and ≥21 (for the depression subscale) are labeled as high or severe. | Baseline up to week 12 | 
| Emotional outcome: Changes on caregiver's general wellbeing | Assessed with the short form of the Mental Health Continuum - short form questionnaire (MHC-SF). Total sum scores on the MHC-SF can range from 0 to 70, with higher scores indicating higher levels of well-being. | Baseline up to week 12 | 
| Emotional outcome: Changes on caregiver's perceived self-efficacy | Perceived self-efficacy assessment with the General Self-Efficacy Scale (GSE), the total score ranges between 10 and 40, with a higher score indicating more self-efficacy. | Baseline up to week 12 | 
| Health-related Quality of Life (HrQoL): Changes on the child's HRQoL | Children HRQoL assessment with KIDSCREEN-10 index answered by the caregiver as a proxy. The scores range between 10 and 50, and are linearly converted into 0-100 scale in which higher scores represent better quality of life. | Baseline up to week 12 | 
| Life-style outcome: Adherence to Mediterranean diet | Assessed with the KIDMED questionnaire. This questionnaire consists of 16 questions, where negative answers are scored with 0, while affirmative answers are scored with +1/-1 depending on their positive or negative connotation. | Baseline up to week 12 | 
| Life-style outcome: physical activity (APALQ) | Physical activity assessed with Assessment Physical Activity Levels Questionnaire (APALQ). It is a self-administered questionnaire with 5 items scored 1 to 4/5, in which the sum of the answers classifies the global score in 3 categories: sedentary (5 to 10), moderately active (11-16), very active (+17). | Baseline up to week 12 | 
| Knowledge of the disease and its treatment. | Medical checking questions related to the disease, its treatment and if the patients are following the multiple doses of insulin (MDI) or the continuous subcutaneous insulin infusion (CSII) treatment. | Baseline up to week 12 | 
| Behavioral outcome: objectively measured children's metabolic control to the treatment | Assessed from the sensor used via glucose monitoring | Baseline up to week 12 | 
| Behavioral outcome: Usability | mHealth solution usability assessed with the System Usability Scale (SUS) questionnaire. SUS can range between 0 and 100 scores, with higher values representing higher usability. | At week 4 (sub-study 1) or week 12 (sub-study 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, mhealth, caregiver, emotional health, behavioral intervention