Telehealth Intervention for Youth With T1DM

Study Overview
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Brief Summary
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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.

Official Title
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Telehealth Intervention for Youth With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Telehealth Intervention
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13 to 17 years Type 1 diabetes for ≥1 year HbA1c>8% Able to speak and read English (Child) Able to speak and read English (Parent) Parent agrees to participate Parent and child each have email addresses Exclusion Criteria: Plan to transition diabetes care to a center other than Boston Children's Hospital No visit to Boston Children's Hospital Diabetes Program in year prior to recruitment Current participation in another diabetes-related study with an intervention Living with or related to another study participant Significant psychopathology or medical illness that would limit the subject's ability to provide assent and/or participate in the study procedures as determined by the PI. No internet access

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth Intervention<br>Telehealth intervention - 6 months | Behavioral: Telehealth Intervention<br>* Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;<br>|
| Active Comparator: Usual care<br>Usual care control with comparable frequency of contact | Other: Usual Care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c | Change in hemoglobin A1c over 6 months | baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, adolescents