Telehealth Intervention for Youth With T1DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01782547
Recruitment Status : Completed
First Posted : February 4, 2013
Last Update Posted : August 15, 2016
Information provided by (Responsible Party):
Erinn T. Rhodes, Children's Hospital Boston

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Telehealth Intervention Other: Usual Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telehealth Intervention for Youth With Type 1 Diabetes
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Telehealth Intervention
Telehealth intervention - 6 months
Behavioral: Telehealth Intervention
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
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

Primary Outcome Measures :
  1. Change in Hemoglobin A1c [ Time Frame: baseline and 6 months ]
    Change in hemoglobin A1c over 6 months

Secondary Outcome Measures :
  1. % patients meeting ADA HbA1c target [ Time Frame: At 6 months ]
    proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5%

  2. Diabetes-related adverse events [ Time Frame: Up to 6 months ]
    number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia

  3. Change in Diabetes self-efficacy [ Time Frame: Baseline and 6 months ]
    change over 6 months assessed by questionnaire

  4. Change in Adherence to diabetes self-management [ Time Frame: Baseline and 6 months ]
    change over 6 months assessed by questionnaire

  5. Change in competence with diabetes skills [ Time Frame: Baseline and 6 months ]
    change over 6 months assessed by questionnaire

  6. Change in Health related quality of life [ Time Frame: Baseline and 6 months ]
    change over 6 months assessed by questionnaire

  7. Change in Diabetes Knowledge [ Time Frame: Baseline and 6 months ]
    Change over 6 months assessed by questionnaire

Other Outcome Measures:
  1. Direct medical costs [ Time Frame: Up to 6 months ]
    Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention.

  2. Change in diabetes-related family conflict [ Time Frame: Baseline and 6 months ]
    assessed by questionnaire

  3. Change in family responsibility for diabetes tasks [ Time Frame: Baseline and 6 months ]
    assessed by questionnaire

  4. Telehealth intervention satisfaction [ Time Frame: At 6 months ]
    satisfaction, engagement, visit characteristics

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01782547

United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Principal Investigator: Erinn T Rhodes, MD, MPH Boston Children’s Hospital

Responsible Party: Erinn T. Rhodes, Director of Endocrinology Healthcare Research and Quality, Children's Hospital Boston Identifier: NCT01782547     History of Changes
Other Study ID Numbers: P00006175
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016

Keywords provided by Erinn T. Rhodes, Children's Hospital Boston:
diabetes mellitus

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