Clinical trial NCT03534193: Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Official title: Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Verizon Foundation
First posted: 2018-05-23
Enrollment: 28
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of 2 arms:

Group 1 - standard Diabetic education-consisting of one on one education with a Registered Nurse in addition to the Molly Center Diabetes Care Guide (paper based) Group 2 - standard Diabetic education plus Bedside tablet with interactive Diabetic modules
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Effectiveness of tablet education in newly diagnosed type 1 diabetes
timeFrame: Test will be completed on day 3 (+/- 2 days)
Secondary outcomes:
measure: Improved subject compliance with glucose monitoring
timeFrame: Assessements will occur at 3 months
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Joseph M. Sanzari Children's Hospital
state: New Jersey
Study officials:
affiliation: Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center
name: Steven Ghanny, MD
role: PRINCIPAL_INVESTIGATOR
References: