Telehealth Intervention for Youth With T1DM

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Telehealth Intervention; Other: Usual Care

• Registration Number: NCT01782547
• Lead Sponsor: Boston Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Study Start: 2013-06
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-12
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telehealth Intervention	Telehealth Intervention	Telehealth intervention - 6 months
Usual care	Usual Care	Usual care control with comparable frequency of contact

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	baseline and 6 months	Change in hemoglobin A1c over 6 months

Secondary Outcome Measures

Name	Time	Method
Change in Adherence to diabetes self-management	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
Change in Health related quality of life	Baseline and 6 months	change over 6 months assessed by questionnaire
Change in Diabetes self-efficacy	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 Diabetes Knowledge	Baseline and 6 months	Change over 6 months assessed by questionnaire

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States