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Hospitalization of youth with established diabetes is both costly and frequently preventable. Poor glycemic control is a risk factor for hospitalization and is also associated with adolescent age and lower socioeconomic status. This is a randomized, controlled trial for high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm and usual care control arm matched for frequency of contacts. There will be 110 subjects with T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston Children's Hospital and followed for 6 months. The intervention will be implemented by a diabetes nurse educator and social worker, who will each have monthly contact with the adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be guided by a diabetes action plan. Telehealth interventions have been utilized successfully in both adults and youth with diabetes. They facilitate frequent contact with the care team allowing barriers to adherence to be addressed, education to be reinforced, care plans to be updated, and diabetes-specific family support to be provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telehealth Intervention | Experimental | Telehealth intervention - 6 months |
|
| Usual care | Active Comparator | Usual care control with comparable frequency of contact |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telehealth Intervention | Behavioral | Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Change in hemoglobin A1c over 6 months | baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| % patients meeting ADA HbA1c target | proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5% | At 6 months |
| Diabetes-related adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Direct medical costs | Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention. | Up to 6 months |
| Change in diabetes-related family conflict |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erinn T Rhodes, MD, MPH | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Usual Care | Other | Standard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month |
|
number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia
| Up to 6 months |
| Change in Diabetes self-efficacy | change over 6 months assessed by questionnaire | Baseline and 6 months |
| Change in Adherence to diabetes self-management | change over 6 months assessed by questionnaire | Baseline and 6 months |
| Change in competence with diabetes skills | change over 6 months assessed by questionnaire | Baseline and 6 months |
| Change in Health related quality of life | change over 6 months assessed by questionnaire | Baseline and 6 months |
| Change in Diabetes Knowledge | Change over 6 months assessed by questionnaire | Baseline and 6 months |
assessed by questionnaire
| Baseline and 6 months |
| Change in family responsibility for diabetes tasks | assessed by questionnaire | Baseline and 6 months |
| Telehealth intervention satisfaction | satisfaction, engagement, visit characteristics | At 6 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |