Diabetes Mellitus, Type 1
Conditions
Keywords
Type 1 Diabetes, mhealth, caregiver, emotional health, behavioral intervention
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.
Detailed description
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).
Interventions
BEHAVIORALAdhera® 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).
Sponsors
Hospital Miguel Servet
Novo Nordisk A/S
Adhera Health, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
Countries
Spain
Outcome results
None listed