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

NCT05483803 | Completed

• 2 other identifiers: CAR-22-001U1111-1280-9100
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Type 1 Diabetes; mhealth; caregiver; emotional health; behavioral intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Emotional outcome: Changes on caregiver's distress

  Baseline up to week 12

• Emotional outcome: Changes on caregiver's general wellbeing

  Baseline up to week 12

• Emotional outcome: Changes on caregiver's perceived self-efficacy

  Baseline up to week 12

• Health-related Quality of Life (HrQoL): Changes on the child's HRQoL

  Baseline up to week 12

• Life-style outcome: Adherence to Mediterranean diet

  Baseline up to week 12

Study Arms (2)

Qualitative sub-study 1 group

EXPERIMENTAL

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

Quantitative sub-study 2 group

EXPERIMENTAL

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

Interventions

Adhera® Caring digital intervention for Type 1 Diabetes BEHAVIORAL

The Adhera® Caring is a mobile based personalized digital intervention for caregivers, lasting for 1 or 3 months (depending on the sub-study).

Qualitative sub-study 1 group; Quantitative sub-study 2 group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adhera Health, Inc.: lead
• Hospital Miguel Servet: collaborator
• Novo Nordisk A/S: collaborator

Study Sites (1)

Hospital Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Related Publications (1)

• 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.

  PMID: 32338624 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Psychological Well-Being

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Antonio de Arriba Muñoz, MD, PhD

  Unidad de Endocrinología Pediátrica, Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Luis Fernandez Luque, PhD

  Adhera Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 2, 2022
• Study Start: October 1, 2022
• Primary Completion: December 14, 2023
• Study Completion: December 14, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)