Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes (CARING-T1D)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: Adhera® Caring digital intervention for Type 1 Diabetes

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Miguel Servet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).
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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Adhera Health, Inc.
• Collaborators: Novo Nordisk A/S; Hospital Miguel Servet
• 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.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 14, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: behavioral intervention; emotional health; Type 1 Diabetes; mhealth; caregiver
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CAR-22-001; U1111-1280-9100 (Registry Identifier: WHO Universal Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No