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Telehealth Intervention for Youth With T1DM

This study is currently recruiting participants.
Verified June 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01782547
First received: January 28, 2013
Last updated: June 18, 2013
Last verified: June 2013
History of Changes
  Purpose

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 and remotely downloaded blood glucose data. 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.


Condition Intervention
Type 1 Diabetes Mellitus
 Behavioral: Telehealth Intervention
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telehealth Intervention for Youth With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Change in Hemoglobin A1c [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
    Change in hemoglobin A1c over 6 months


Secondary Outcome Measures:
  • % patients meeting ADA HbA1c target [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia

  • Change in Diabetes self-efficacy [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change over 6 months assessed by questionnaire

  • Change in Adherence to diabetes self-management [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change over 6 months assessed by questionnaire

  • Change in competence with diabetes skills [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change over 6 months assessed by questionnaire

  • Change in Health related quality of life [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    change over 6 months assessed by questionnaire

  • Change in Diabetes Knowledge [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Change over 6 months assessed by questionnaire


Other Outcome Measures:
  • Direct medical costs [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention.

  • Change in diabetes-related family conflict [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    assessed by questionnaire

  • Change in family responsibility for diabetes tasks [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    assessed by questionnaire

  • Telehealth intervention satisfaction [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    satisfaction, engagement, visit characteristics


Estimated Enrollment: 110
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telehealth Intervention
Telehealth intervention - 6 months
 Behavioral: Telehealth Intervention
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan; Monthly remote blood glucose meter download
Active Comparator: Usual care
Usual care control with comparable frequency of contact
 Other: 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

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Use of insulin injections or Medtronic insulin pump

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782547

Contacts
Contact: Erinn T Rhodes, MD, MPH 617-355-3209 erinn.rhodes@childrens.harvard.edu
Contact: Erica Denhoff 857-218-4714 erica.denhoff@childrens.harvard.edu

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Erinn Rhodes, MD, MPH     617-355-3209     erinn.rhodes@childrens.harvard.edu    
Contact: Erica Denhoff     857-218-4714     erica.denhoff@childrens.harvard.edu    
Principal Investigator: Erinn T Rhodes, MD, MPH            
Sub-Investigator: Joseph Wolfsdorf, MB, BCh            
Sub-Investigator: Lauren Mednick, PhD            
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Erinn T Rhodes, MD, MPH Boston Children's Hospital
  More Information

No publications provided

Responsible Party: Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01782547     History of Changes
Other Study ID Numbers: P00006175
Study First Received: January 28, 2013
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
diabetes mellitus
adolescents

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013