Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Behavioral: Teens-Connect; Behavioral: Planet D

• Registration Number: NCT01783327
• Lead Sponsor: Yale University

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 (TEENCOPE™+Managing 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 stress/coping, 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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Read More

Exclusion Criteria

*Previous exposure to TEENCOPE and/or Managing Diabetes

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teens-Connect	Teens-Connect	The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE.
Planet D	Planet D	Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes.

Primary Outcome Measures

Name	Time	Method
Change from baseline hemoglobin A1c over 12 months	Baseline, 6 weeks, 6 months, 12 months
Change from baseline quality of life over 12 months	Baseline, 6 weeks, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline coping/Stress over 12 months	Baseline, 6 weeks, 6 months, 12 months	Coping/stress will be measured using the Perceived Stress Scale
Change from baseline quality adjusted life years over 12 months	Baseline, 6 weeks, 6 months, 12 months	Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent)
Change from baseline problem-solving over 12 months	Baseline, 6 weeks, 6 months, 12 months	Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire
Change from baseline self-efficacy over 12 months	Baseline, 6 weeks, 6 months, 12 months	Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale
Change from baseline self-management over 12 months	Baseline, 6 weeks, 6 months, 12 months	Self-management will be assessed using the Self-care Inventory (SCI)
Costs	6 months	Costs will be assessed using financial and staff records

Trial Locations

Locations (2)

Yale University School of Nursing; 🇺🇸 New Haven, Connecticut, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States