Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT05483803
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Sponsor:
Adhera Health, Inc.
Organization:
Study Overview
Official Title:
CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARING-T1D
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.
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).
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1280-9100 | REGISTRY | WHO Universal Trial Number | View |