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

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

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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