NCT05483803Completed
Digital Health Intervention for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
CARING: Feasibility Study of Digital Health for Caregivers Emotional and Self-management Support of Children With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 1 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 28 Jul 2022
- Start date
- 1 Oct 2022
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- Adhera Health, Inc.
- Diseases
- Type 1 diabetes
- NCT number
- NCT05483803
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 1 Oct 2022 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.