Clinical trial NCT01782547: Telehealth Intervention for Youth With T1DM
Official title: Telehealth Intervention for Youth With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes mellitus
adolescents
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 32
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: baseline and 6 months
Secondary outcomes:
measure: % patients meeting ADA HbA1c target
timeFrame: At 6 months
measure: Diabetes-related adverse events
timeFrame: Up to 6 months
measure: Change in Diabetes self-efficacy
timeFrame: Baseline and 6 months
measure: Change in Adherence to diabetes self-management
timeFrame: Baseline and 6 months
measure: Change in competence with diabetes skills
timeFrame: Baseline and 6 months
measure: Change in Health related quality of life
timeFrame: Baseline and 6 months
measure: Change in Diabetes Knowledge
timeFrame: Baseline and 6 months
Other outcomes:
measure: Direct medical costs
timeFrame: Up to 6 months
measure: Change in diabetes-related family conflict
timeFrame: Baseline and 6 months
measure: Change in family responsibility for diabetes tasks
timeFrame: Baseline and 6 months
measure: Telehealth intervention satisfaction
timeFrame: At 6 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Erinn T Rhodes, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: