Telehealth Intervention for Youth With T1DM

August 12, 2016 updated by: Erinn T. Rhodes, Boston Children's Hospital

Telehealth Intervention for Youth With Type 1 Diabetes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin A1c
Time Frame: baseline and 6 months
Change in hemoglobin A1c over 6 months
baseline and 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
% 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%
At 6 months
Diabetes-related adverse events
Time Frame: Up to 6 months
number of diabetes-related hospitalizations, ED visits, and episodes of severe hypoglycemia
Up to 6 months
Change in Diabetes self-efficacy
Time Frame: Baseline and 6 months
change over 6 months assessed by questionnaire
Baseline and 6 months
Change in Adherence to diabetes self-management
Time Frame: Baseline and 6 months
change over 6 months assessed by questionnaire
Baseline and 6 months
Change in competence with diabetes skills
Time Frame: Baseline and 6 months
change over 6 months assessed by questionnaire
Baseline and 6 months
Change in Health related quality of life
Time Frame: Baseline and 6 months
change over 6 months assessed by questionnaire
Baseline and 6 months
Change in Diabetes Knowledge
Time Frame: Baseline and 6 months
Change over 6 months assessed by questionnaire
Baseline and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months
Change in diabetes-related family conflict
Time Frame: Baseline and 6 months
assessed by questionnaire
Baseline and 6 months
Change in family responsibility for diabetes tasks
Time Frame: Baseline and 6 months
assessed by questionnaire
Baseline and 6 months
Telehealth intervention satisfaction
Time Frame: At 6 months
satisfaction, engagement, visit characteristics
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erinn T Rhodes, MD, MPH, Boston Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P00006175

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings