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

NCT ID: NCT03534193

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2025-04-08

Brief Summary

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).

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard Diabetic Education

Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)

Group Type: OTHER

Molly Center Diabetes Care Guide (Paper-based)

Intervention Type: OTHER

Diabetes education with Registered Nurse in addition to Paper based education modules

Standard Diabetes Education and Tablet

Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules

Group Type: EXPERIMENTAL

Molly Center Diabetes Care Guide (Paper-based)

Intervention Type: OTHER

Diabetes education with Registered Nurse in addition to Paper based education modules

Tablet based interactive diabetes education modules

Intervention Type: OTHER

Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.

Interventions

Molly Center Diabetes Care Guide (Paper-based)

Diabetes education with Registered Nurse in addition to Paper based education modules

Intervention Type: OTHER

Tablet based interactive diabetes education modules

Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Verizon Foundation

OTHER

Sponsor Role: collaborator

Hackensack Meridian Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Ghanny, MD

Role: PRINCIPAL_INVESTIGATOR

Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center

Locations

Joseph M. Sanzari Children's Hospital

Hackensack, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

PRO 2016-0713

Identifier Type: -

Identifier Source: org_study_id