Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molly Center Diabetes Care Guide (Paper-based)
Tablet based interactive diabetes education modules
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes Mellitus
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
Sites / Locations
- Joseph M. Sanzari Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Group 1
Group 2
Arm Description
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Outcomes
Primary Outcome Measures
Effectiveness of tablet education in newly diagnosed type 1 diabetes
Effectiveness of tablet education modules as measured by a diabetic knowledge post test questionnaire
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03534193
First Posted
May 9, 2018
Last Updated
February 22, 2023
Sponsor
Hackensack Meridian Health
Collaborators
Verizon Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03534193
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Site resources
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
Collaborators
Verizon Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Other
Arm Description
Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules
Intervention Type
Other
Intervention Name(s)
Molly Center Diabetes Care Guide (Paper-based)
Intervention Description
Diabetes education with Registered Nurse in addition to Paper based education modules
Intervention Type
Other
Intervention Name(s)
Tablet based interactive diabetes education modules
Intervention Description
Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
Primary Outcome Measure Information:
Title
Effectiveness of tablet education in newly diagnosed type 1 diabetes
Description
Effectiveness of tablet education modules as measured by a diabetic knowledge post test questionnaire
Time Frame
Test will be completed on day 3 (+/- 2 days)
Secondary Outcome Measure Information:
Title
Improved subject compliance with glucose monitoring
Description
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
Time Frame
Assessements will occur at 3 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Ghanny, MD
Organizational Affiliation
Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joseph M. Sanzari Children's Hospital
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Using Educational Modules Via Bedside Tablet in Newly Diagnosed Type 1 Diabetes
We'll reach out to this number within 24 hrs