Clinical trial NCT05483803: Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Official title: CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 Diabetes
mhealth
caregiver
emotional health
behavioral intervention
Lead sponsor: Adhera Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hospital Miguel Servet
name: Novo Nordisk A/S
First posted: 2022-08-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 Month
measure: Sub-study 2: Changes on caregiver's positive mood
timeFrame: 3 Months
Secondary outcomes:
measure: Emotional outcome: Changes on caregiver's distress
timeFrame: Baseline up to week 12
measure: Emotional outcome: Changes on caregiver's general wellbeing
timeFrame: Baseline up to week 12
measure: Emotional outcome: Changes on caregiver's perceived self-efficacy
timeFrame: Baseline up to week 12
measure: Health-related Quality of Life (HrQoL): Changes on the child's HRQoL
timeFrame: Baseline up to week 12
measure: Life-style outcome: Adherence to Mediterranean diet
timeFrame: Baseline up to week 12
measure: Life-style outcome: physical activity (APALQ)
timeFrame: Baseline up to week 12
measure: Knowledge of the disease and its treatment.
timeFrame: Baseline up to week 12
measure: Behavioral outcome: objectively measured children's metabolic control to the treatment
timeFrame: Baseline up to week 12
measure: Behavioral outcome: Usability
timeFrame: At week 4 (sub-study 1) or week 12 (sub-study 2)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragon
Study officials:
affiliation: Unidad de Endocrinología Pediátrica, Hospital Miguel Servet
name: Antonio de Arriba Muñoz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Adhera Health, Inc.
name: Luis Fernandez Luque, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.