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| Name | Class |
|---|---|
| Verizon Foundation | OTHER |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Diabetic Education | Other | Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) |
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| Standard Diabetes Education and Tablet | Experimental | Participants randomized to Group 2 will receive Molly Center Standard Diabetes Education plus access to Tablet based interactive diabetes education modules |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molly Center Diabetes Care Guide (Paper-based) | Other | Diabetes education with Registered Nurse in addition to Paper based education modules |
|
| 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. Total score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge. | Test will be completed on day 3 (+/- 2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Improved Subject Compliance With Glucose Monitoring A1 Levels | Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by Lower Hemoglobin A1C at initial follow up visit | Assessements will occur at 3 months |
| Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Ghanny, MD | Joseph M.Sanzari Children's Hospital at Hackensack University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey | 07601 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Diabetes Education | Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules |
| FG001 | 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 Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Diabetes Education | Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Tablet Education in Newly Diagnosed Type 1 Diabetes | Effectiveness of tablet education modules as measured by a diabetic knowledge post-test questionnaire. Total score ranges from 0-100%, with a higher percentage on the scale indicating a better outcome/knowledge. | post-education test score (percentile of questions answered correctly) | Posted | Mean | Full Range | percentage of questions answered correct | Test will be completed on day 3 (+/- 2 days) |
|
Up until study completion (3 months +/- 20 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Diabetes Education | Participants randomized to Group 1 will receive Standard Diabetic Education with Registered Nurse and Molly Center Diabetes Care Guide (paper-based) Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules |
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The team experienced difficulties in collecting the number of blood sugar checks from the patients who did not report it for either group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Ghanny, MD | Hackensack Meridian Health | 5519965329 | steven.ghanny@hmhn.org |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2017 | May 30, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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
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| Tablet based interactive diabetes education modules | Other | Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. |
|
Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by lower number of hypoglycemic episodes before initial follow up visit |
| Assessements will occur at 3 months |
| Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring | Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by compliance with daily blood glucose monitoring at initial follow up visit | Assessements will occur at 3 months |
| 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 Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 |
| 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 Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. |
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| Secondary | Improved Subject Compliance With Glucose Monitoring A1 Levels | 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 HbA1C comparing to baseline | Posted | Mean | Full Range | percentage change in HbA1C | Assessements will occur at 3 months |
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| Secondary | Improved Subject Compliance With Glucose Monitoring - Hypoglycemic Episodes | Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by lower number of hypoglycemic episodes before initial follow up visit | number of Hypoglycemic Episodes | Posted | Mean | Full Range | number of Hypoglycemic Episodes | Assessements will occur at 3 months |
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| Secondary | Improved Subject Compliance With Glucose Monitoring - Compliance With Daily Blood Glucose Monitoring | Subjects randomized to tablet education modules will demonstrate improved compliance with glucose monitoring as measured by compliance with daily blood glucose monitoring at initial follow up visit | Number of times blood sugar was checked. Data was not collected as patients did not report it for either group. | Posted | Assessements will occur at 3 months |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | 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 Molly Center Diabetes Care Guide (Paper-based): Diabetes education with Registered Nurse in addition to Paper based education modules Tablet based interactive diabetes education modules: Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet. | 0 | 11 | 0 | 11 | 0 | 11 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |