Type 1 Diabetes Mellitus
Conditions
Keywords
diabetes mellitus, adolescents
Brief summary
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.
Interventions
BEHAVIORALTelehealth Intervention
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
OTHERUsual Care
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
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | baseline and 6 months | Change in hemoglobin A1c over 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diabetes self-efficacy | Baseline and 6 months | change over 6 months assessed by questionnaire |
| Change in Adherence to diabetes self-management | Baseline and 6 months | change over 6 months assessed by questionnaire |
| Change in competence with diabetes skills | Baseline and 6 months | change over 6 months assessed by questionnaire |
| Change in Health related quality of life | Baseline and 6 months | change over 6 months assessed by questionnaire |
| Change in Diabetes Knowledge | Baseline and 6 months | Change over 6 months assessed by questionnaire |
| % patients meeting ADA HbA1c target | At 6 months | proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is \<7.5% |
| Diabetes-related adverse events | Up to 6 months | number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in family responsibility for diabetes tasks | Baseline and 6 months | assessed by questionnaire |
| Telehealth intervention satisfaction | At 6 months | satisfaction, engagement, visit characteristics |
| Direct medical costs | Up to 6 months | Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention. |
| Change in diabetes-related family conflict | Baseline and 6 months | assessed by questionnaire |
Countries
United States
Outcome results
None listed