Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Crowdsourced Social Media Portal for Parents of Very Young Children With Type 1 Diabetes

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03222180
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy Wysocki, Nemours Children's Clinic

Brief Summary:
The first 2 years of this project consisted of user-centered design and development of an online resource designed by and for parents of very young children with type 1 diabetes (under 6 years old). That phase of the work has been completed and recruitment has begun for the second phase, which is a randomized controlled trial to evaluate the effects of use of this resource on a variety of pertinent child and parent outcomes. INTERESTED, ELIGIBLE PARENTS OR GUARDIANS CAN LEARN MORE BY NAVIGATING TO: www.bit.ly/youngT1D

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Website Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The study design consists of randomization of parents of 150 children with T1D to either Website (n=100) or Usual Care (n=50) for 6 months followed by all participants reverting to the Website condition for the subsequent 6 months.
Masking: Single (Outcomes Assessor)
Masking Description: Persons administering and scoring study questionnaires will be blinded to the participants' group assignments,
Primary Purpose: Health Services Research
Official Title: A Crowdsourced Social Media Portal for Parents of Very Young Children With Type 1 Diabetes
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Website
Participants will be provided with password-protected access to use of the online resource created during the first phase of the project during the one year randomized controlled trial. Participants' children with T1D will receive Usual Care for T1D as described below.
Behavioral: Website
Participants in the Website condition will be provided with password-protected access to the online resource created for this trial that provides a variety of information, support and guidance that could permit them to adapt more effectively to the demands of parenting a very young child with type 1 diabetes.

No Intervention: Usual Care
Participants' children with T1D will receive care for T1D at their respective institutions equivalent to that received by comparable patients who do not enroll in the trial. At all sites, Usual Care is designed to be consistent with the current American Diabetes Association Standards of Care for T1D in this clinical population.



Primary Outcome Measures :
  1. Parental adjustment [ Time Frame: 12 months ]
    Questionnaire scores

  2. Child adjustment [ Time Frame: 12 months ]
    Questionnaire scores

  3. Glycated hemoglobin (Hemoglobin A1c) [ Time Frame: 12 months ]
    Change in child's glycated hemoglobin level during the trial


Secondary Outcome Measures :
  1. Severe hypoglycemia [ Time Frame: 12 months ]
    Frequency of severe hypoglycemic events

  2. Health care utilization [ Time Frame: 12 months ]
    Hospitalizations or ED visits associated with T1D

  3. Website utilization [ Time Frame: 12 months ]
    Automated collection of website logins, navigation, duration of use, etc.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent or legal guardian of a child with T1D < 6 years old at enrollment
  • Child and parent/guardian live in the United States
  • Parent is able to read and comprehend written English
  • Access to the internet

Exclusion Criteria:

  • Inability to read or comprehend study questionnaires or website content

INTERESTED, ELIGIBLE PARENTS OR GUARDIANS CAN LEARN MORE BY NAVIGATING TO: www.bit.ly/youngT1D


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 ClinicalTrials.gov identifier (NCT number): NCT03222180


Contacts
Layout table for location contacts
Contact: Vicky Funanage, PhD 302-651-6819 vfunanag@nemours.org
Contact: Jeannie Yen, MBA 904-697-3483 jeannie.yen@nemours.org

Locations
Layout table for location information
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Alex Taylor, MACP    904-697-3507    ataylor@nemours.org   
Contact: Amy Milkes, MS    904-697-3047    amilkes@nemours.org   
Principal Investigator: Tim Wysocki, Ph.D.         
Sponsors and Collaborators
Nemours Children's Clinic

Publications:
Layout table for additonal information
Responsible Party: Timothy Wysocki, Center Co-Director and Principal Research Scientist, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT03222180     History of Changes
Other Study ID Numbers: 1DP3DK108198 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the results pertinent to the specific aims have been accepted for publication, a de-identified data set will be placed in a publicly accessible secure location along with an accompanying data dictionary. Access to the data set will be limited to those persons who sing and submit a data use agreement that ensures protection of the confidentiality of the study participants.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Once the results pertinent to each of the specific aims have been accepted for publication.
Access Criteria: Access to the data set will be limited to those persons who sign and submit a data use agreement that ensures protection of the confidentiality of the study participants.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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