Viewing Study NCT01783327



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Study NCT ID: NCT01783327
Status: COMPLETED
Last Update Posted: 2016-01-08
First Post: 2013-01-28

Brief Title: Teens-Connect Preventive Psycho-education for Transitioning Teens With Diabetes
Sponsor: Yale University
Organization: Yale University

Study Overview

Official Title: Teens-Connect Preventive Psycho-education for Transitioning Teens With Diabetes
Status: COMPLETED
Status Verified Date: 2016-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: TeensConnect
Brief Summary: The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice Teens-Connect compared to use of a standard and widely available internet diabetes program for youth Planet D in a mixed-method randomized clinical trial design
Detailed Description: The aims are

1 To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect TEENCOPEManaging Diabetes in pediatric diabetes practice compared to prescription of Planet D

The hypotheses to be studied are
1 Youth who participate in Teens-Connect will have better metabolic control A1c and quality of life QOL than those who participate in Planet D
2 These effects will be mediated by improvements in stresscoping self-efficacy diabetes problem-solving and self-management
3 Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years QALYs for youth with T1D
2 To compare the reach efficacy adoption implementation and maintenance RE-AIM of the two provider-prescribed psycho-educational internet programs

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None