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Trial record 22 of 2460 for:    Diabetes | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03534193
Recruitment Status : Recruiting
First Posted : May 23, 2018
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Verizon Foundation
Information provided by (Responsible Party):
Hackensack Meridian Health

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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: Molly Center Diabetes Care Guide (Paper-based) Other: Tablet based interactive diabetes education modules Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.




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


Secondary Outcome Measures :
  1. Improved subject compliance with glucose monitoring [ Time Frame: Assessements will occur at 3 months ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534193


Contacts
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Contact: Susan Mathus, BSN 551-996-8178 susan.mathus@hackensackmeridian.org
Contact: Michele De Vito, BSN 551-996-8295 michele.devito@hackensackmeridian.org

Locations
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United States, New Jersey
Joseph M. Sanzari Children's Hospital Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Susan Mathus, BSN    551-996-8178    susan.mathus@hackensackmeridian.org   
Sponsors and Collaborators
Hackensack Meridian Health
Verizon Foundation
Investigators
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Principal Investigator: Steven Ghanny, MD Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT03534193     History of Changes
Other Study ID Numbers: PRO 2016-0713
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases