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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1280-9100 | Registry Identifier | WHO Universal Trial Number |
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| Name | Class |
|---|---|
| Hospital Miguel Servet | OTHER |
| Novo Nordisk A/S | INDUSTRY |
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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.
Objectives:
This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualitative sub-study 1 group | Experimental | One group of caregivers (n = 20) will engage with the digital health solution during 1 month. |
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| Quantitative sub-study 2 group | Experimental | A different group of caregivers (n = 80) will engage with the digital health solution during 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhera® Caring digital intervention for Type 1 Diabetes | Behavioral | The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study). |
| 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 |
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio de Arriba Muñoz, MD, PhD | Unidad de EndocrinologÃa Pediátrica, Hospital Miguel Servet | Principal Investigator |
| Luis Fernandez Luque, PhD | Adhera Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Miguel Servet | Zaragoza | Aragon | 50009 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32338624 | Background | Carrasco-Hernandez L, Jodar-Sanchez F, Nunez-Benjumea F, Moreno Conde J, Mesa Gonzalez M, Civit-Balcells A, Hors-Fraile S, Parra-Calderon CL, Bamidis PD, Ortega-Ruiz F. A Mobile Health Solution Complementing Psychopharmacology-Supported Smoking Cessation: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Apr 27;8(4):e17530. doi: 10.2196/17530. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| 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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |