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
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Behavioral: Website||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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|
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.
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.
- Parental adjustment [ Time Frame: 12 months ]Questionnaire scores
- Child adjustment [ Time Frame: 12 months ]Questionnaire scores
- Glycated hemoglobin (Hemoglobin A1c) [ Time Frame: 12 months ]Change in child's glycated hemoglobin level during the trial
- Severe hypoglycemia [ Time Frame: 12 months ]Frequency of severe hypoglycemic events
- Health care utilization [ Time Frame: 12 months ]Hospitalizations or ED visits associated with T1D
- Website utilization [ Time Frame: 12 months ]Automated collection of website logins, navigation, duration of use, etc.
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
|Contact: Vicky Funanage, PhDfirstname.lastname@example.org|
|Contact: Jeannie Yen, MBAemail@example.com|
|United States, Florida|
|Nemours Children's Clinic||Recruiting|
|Jacksonville, Florida, United States, 32207|
|Contact: Alex Taylor, MACP 904-697-3507 firstname.lastname@example.org|
|Contact: Amy Milkes, MS 904-697-3047 email@example.com|
|Principal Investigator: Tim Wysocki, Ph.D.|