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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 14, 2023

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

  • 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).

Arms, Groups and Cohorts

  • Experimental: Qualitative sub-study 1 group
    • One group of caregivers (n = 20) will engage with the digital health solution during 1 month.
  • Experimental: Quantitative sub-study 2 group
    • A different group of caregivers (n = 80) will engage with the digital health solution during 3 months.

Clinical Trial Outcome Measures

Primary 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
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Emotional outcome: Changes on caregiver’s distress
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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.
    • Time Frame: 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
    • Time Frame: Baseline up to week 12
    • Assessed from the sensor used via glucose monitoring
  • Behavioral outcome: Usability
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Adhera Health, Inc.
  • Collaborator
    • Hospital Miguel Servet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Antonio de Arriba Muñoz, MD, PhD, Principal Investigator, Unidad de Endocrinología Pediátrica, Hospital Miguel Servet
    • Luis Fernandez Luque, PhD, Principal Investigator, Adhera Health, Inc.

References

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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