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Clinical Trials/NCT01782547
NCT01782547
Completed
Not Applicable

Telehealth Intervention for Youth With Type 1 Diabetes

Boston Children's Hospital1 site in 1 country32 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Boston Children's Hospital
Enrollment
32
Locations
1
Primary Endpoint
Change in Hemoglobin A1c
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
May 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Erinn T. Rhodes

Director of Endocrinology Healthcare Research and Quality

Boston Children's Hospital

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

Outcomes

Primary Outcomes

Change in Hemoglobin A1c

Time Frame: baseline and 6 months

Change in hemoglobin A1c over 6 months

Secondary Outcomes

  • Change in Adherence to diabetes self-management(Baseline and 6 months)
  • % patients meeting ADA HbA1c target(At 6 months)
  • Diabetes-related adverse events(Up to 6 months)
  • Change in Health related quality of life(Baseline and 6 months)
  • Change in Diabetes self-efficacy(Baseline and 6 months)
  • Change in competence with diabetes skills(Baseline and 6 months)
  • Change in Diabetes Knowledge(Baseline and 6 months)

Study Sites (1)

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