Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
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
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