Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes (TeensConnect)

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Yale University

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Treatments

Behavioral: Planet D
Behavioral: Teens-Connect

Study type

Interventional

Funder types

Other

Identifiers

NCT01783327
1112009416

Details and patient eligibility

About

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.

Full description

The aims are: To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™. The hypotheses to be studied are: Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D. These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management. 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. To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.

Enrollment

124 patients

Sex

All

Ages

11 to 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed with type 1 diabetes for at least 6 months
  • Age 11 to 14 years
  • English-speaking
  • Assent
  • Parent/guardian consent to participate in study

Exclusion criteria

*Previous exposure to TEENCOPE and/or Managing Diabetes

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

124 participants in 2 patient groups

Teens-Connect
Experimental group
Description:
The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE.
Treatment:
Behavioral: Teens-Connect
Planet D
Active Comparator group
Description:
Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes.
Treatment:
Behavioral: Planet D

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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