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Telehealth Intervention for Youth With T1DM

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth Intervention
Usual Care
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring diabetes mellitus, adolescents

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telehealth Intervention

Usual care

Arm Description

Telehealth intervention - 6 months

Usual care control with comparable frequency of contact

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c
Change in hemoglobin A1c over 6 months

Secondary Outcome Measures

% patients meeting ADA HbA1c target
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
number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia
Change in Diabetes self-efficacy
change over 6 months assessed by questionnaire
Change in Adherence to diabetes self-management
change over 6 months assessed by questionnaire
Change in competence with diabetes skills
change over 6 months assessed by questionnaire
Change in Health related quality of life
change over 6 months assessed by questionnaire
Change in Diabetes Knowledge
Change over 6 months assessed by questionnaire

Full Information

First Posted
January 28, 2013
Last Updated
August 12, 2016
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01782547
Brief Title
Telehealth Intervention for Youth With T1DM
Official Title
Telehealth Intervention for Youth With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetes mellitus, adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telehealth Intervention
Arm Type
Experimental
Arm Description
Telehealth intervention - 6 months
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care control with comparable frequency of contact
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Intervention
Intervention Description
Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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 Measure Information:
Title
Change in Hemoglobin A1c
Description
Change in hemoglobin A1c over 6 months
Time Frame
baseline and 6 months
Secondary Outcome Measure Information:
Title
% patients meeting ADA HbA1c target
Description
proportion of patients meeting the American Diabetes Association target for optimal glycemic control in this age group, which is <7.5%
Time Frame
At 6 months
Title
Diabetes-related adverse events
Description
number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia
Time Frame
Up to 6 months
Title
Change in Diabetes self-efficacy
Description
change over 6 months assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Change in Adherence to diabetes self-management
Description
change over 6 months assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Change in competence with diabetes skills
Description
change over 6 months assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Change in Health related quality of life
Description
change over 6 months assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Change in Diabetes Knowledge
Description
Change over 6 months assessed by questionnaire
Time Frame
Baseline and 6 months
Other Pre-specified Outcome Measures:
Title
Direct medical costs
Description
Direct medical costs include planned intervention costs and medical costs that are expected to change as a result of the intervention.
Time Frame
Up to 6 months
Title
Change in diabetes-related family conflict
Description
assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Change in family responsibility for diabetes tasks
Description
assessed by questionnaire
Time Frame
Baseline and 6 months
Title
Telehealth intervention satisfaction
Description
satisfaction, engagement, visit characteristics
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erinn T Rhodes, MD, MPH
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Telehealth Intervention for Youth With T1DM

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