Telehealth Intervention for Youth With T1DM

NCT ID: NCT01782547

Last Updated: 2016-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telehealth Intervention

Telehealth intervention - 6 months

Group Type: EXPERIMENTAL

Telehealth Intervention

Intervention Type: BEHAVIORAL

Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;

Usual care

Usual care control with comparable frequency of contact

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

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

Interventions

Telehealth Intervention

Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;

Intervention Type: BEHAVIORAL

Usual 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Erinn T. Rhodes

Director of Endocrinology Healthcare Research and Quality

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erinn T Rhodes, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00006175

Identifier Type: -

Identifier Source: org_study_id