Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes (CARING T1D)
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Objectives:
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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.
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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:
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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.
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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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Qualitative sub-study 1 group 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
The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).
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Experimental: Quantitative sub-study 2 group 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
The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).
|
Outcome Measures
Primary Outcome Measures
- 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 [1 Month]
A semi-structured interview based on a mental health and technology acceptance theoretical framework has been specifically designed for this purpose.
- Sub-study 2: Changes on caregiver's positive mood [3 Months]
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.
Secondary Outcome Measures
- Emotional outcome: Changes on caregiver's distress [Baseline up to week 12]
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".
- Emotional outcome: Changes on caregiver's general wellbeing [Baseline up to week 12]
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.
- Emotional outcome: Changes on caregiver's perceived self-efficacy [Baseline up to week 12]
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.
- Health-related Quality of Life (HrQoL): Changes on the child's HRQoL [Baseline up to week 12]
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.
- Life-style outcome: Adherence to Mediterranean diet [Baseline up to week 12]
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.
- Life-style outcome: physical activity (APALQ) [Baseline up to week 12]
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).
- Knowledge of the disease and its treatment. [Baseline up to week 12]
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.
- Behavioral outcome: objectively measured children's metabolic control to the treatment [Baseline up to week 12]
Assessed from the sensor used via glucose monitoring
- Behavioral outcome: Usability [At week 4 (sub-study 1) or week 12 (sub-study 2)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Caregiver of patients with type 1 diabetes under 18 years of age.
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Patient's debut of type 1 diabetes at least 3 months prior to the start of the study.
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Patients with continuous glucose monitoring.
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Participants with children undergoing insulin treatments (multiple dose insulin or continuous subcutaneous insulin infusion)
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Participants administering insulin treatment to their children
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Users of smartphone whose children are treated with type 1 diabetes treatment for approved indications in Spain.
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Participants must agree on sharing data on continuous glucose monitoring data of their treated children.
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Participants must sign an informed consent
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Participants must be willing to and install the mobile solution of the study.
Exclusion Criteria:
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Candidates without a smartphone or not being able to interact with it.
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Only one legal guardian per child can participate in the study.
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Participants of SS1 will not take part in SS2.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Miguel Servet | Zaragoza | Aragon | Spain | 50009 |
Sponsors and Collaborators
- Adhera Health, Inc.
- Hospital Miguel Servet
- Novo Nordisk A/S
Investigators
- Principal Investigator: Antonio de Arriba Muñoz, MD, PhD, Unidad de Endocrinología Pediátrica, Hospital Miguel Servet
- Principal Investigator: Luis Fernandez Luque, PhD, Adhera Health, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
- CAR-22-001
- U1111-1280-9100