Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes

This is a prospective, randomized trial to evaluate the effectiveness of using educational modules accessed through a bedside tablet in patients newly diagnosed with Type 1 Diabetes as an adjunct to *standard Children's Hospital- Molly Center diabetes education in comparison to *standard Children's Hospital- Molly Center diabetes education. (standard diabetes education consists of paper based reading material and nursing education).

Study Overview

• Status: Suspended
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Molly Center Diabetes Care Guide (Paper-based); Other: Tablet based interactive diabetes education modules

Detailed Description

Type I diabetes is one of the most common diseases of childhood and its incidence has been increasing worldwide. By age 18, 1 in 300 children will be affected by Type 1 Diabetes1. Not only are children diagnosed with diabetes met with significant morbidity due to their disease, but they are also expected to be active participants in daily often complicated treatment regimens. As children with Type 1 diabetes grow older and eventually spend time away from their parents or caregivers, they are forced to manage their own care. Over the last several years, health systems in the United States have become more patient-centered and have focused on autonomy and patient preference. With the advent of technology that makes self-directed education possible, this patient-centered approach needs to be applied to children diagnosed with Type I diabetes.

When clinicians are at the center of educating patients with diabetes, they often communicate more directly with parents, who then use the information they receive to manage their child's care. This model, however, does not account for the fact that children with diabetes will one day need to manage their own care and that patients who are active participants and who understand their disease process will be more likely to cooperate with treatment regimens and lifestyle interventions. It is often difficult for any patient, child or adult, to process educational information provided verbally in a physician's office, especially immediately after they have been diagnosed with a life-long disease. Educational tools therefore need to focus on incorporating methods that best serve the patients being educated.

Since individuals learn in different ways and at different paces, interactive educational tools can help patients and their families learn in a way that can be individualized and private and can also be fun and creative. As our patients are growing up surrounded by technology, the use of this technology for education might provide a sense of normalcy to children and teenagers already overwhelmed by processes that are often difficult for them to identify with or understand. We hope that patients and families who are given the opportunity to learn independently will become better equipped to manage self-care and will develop a sense of involvement in their treatment. Interactive tools will also help patients and families become more actively engaged in understanding their disease process and can help them to become more active participants in their care.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Joseph M. Sanzari Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• New diagnosed Type 1 Diabetes admitted to the Joseph M. Sanzari Children's Hospital
• Patient/Caretaker/Family willing to complete questionnaires

Exclusion Criteria:

• Patients with previous history of Diabetes
• Patients with no plans to follow up at The Joseph M. Sanzari Children's Hospital - Molly's Center for Children with Diabetes and Endocrine Disorders after hospital discharge
• Non English speaking patients/family/caretaker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group 1; Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)	Other: Molly Center Diabetes Care Guide (Paper-based); Diabetes education with Registered Nurse in addition to Paper based education modules
Experimental: Group 2; Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules	Other: Molly Center Diabetes Care Guide (Paper-based); Diabetes education with Registered Nurse in addition to Paper based education modules; Other: Tablet based interactive diabetes education modules; Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of tablet education in newly diagnosed type 1 diabetes	Effectiveness of tablet education modules as measured by a diabetic knowledge post test questionnaire	Test will be completed on day 3 (+/- 2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved subject compliance with glucose monitoring	Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by: Lower Hemoglobin A1C at initial follow up visit, Lower number of hypoglycemic episodes before initial follow up visit, and Increased compliance with daily blood glucose monitoring at initial follow up visit	Assessements will occur at 3 months

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: Verizon Foundation
• Investigators: Principal Investigator: Steven Ghanny, MD, Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• 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: PRO 2016-0713

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