Telehealth Intervention for Youth With T1DM

NCT01782547 | Completed

• 1 other identifier: P00006175
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

diabetes mellitus; adolescents

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  Change in hemoglobin A1c over 6 months

  baseline and 6 months

Secondary Outcomes (7)

• % patients meeting ADA HbA1c target

  At 6 months

• Diabetes-related adverse events

  Up to 6 months

• Change in Diabetes self-efficacy

  Baseline and 6 months

• Change in Adherence to diabetes self-management

  Baseline and 6 months

• Change in competence with diabetes skills

  Baseline and 6 months

Other Outcomes (4)

• Direct medical costs

  Up to 6 months

• Change in diabetes-related family conflict

  Baseline and 6 months

• Change in family responsibility for diabetes tasks

  Baseline and 6 months

Study Arms (2)

Telehealth Intervention

EXPERIMENTAL

Telehealth intervention - 6 months

Behavioral: Telehealth Intervention

Usual care

ACTIVE COMPARATOR

Usual care control with comparable frequency of contact

Other: Usual Care

Interventions

Telehealth Intervention BEHAVIORAL

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

Telehealth Intervention

Usual Care 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

Usual care

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Erinn T Rhodes, MD, MPH

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology Healthcare Research and Quality

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 4, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: August 15, 2016

Record last verified: 2016-08

Locations

US (1)