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

January 6, 2016 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School of Nursing
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teens-Connect
The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE.
Behavioral: Teens-Connect
Teens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks.
Active Comparator: Planet D
Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes.
Behavioral: Planet D
Planet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline hemoglobin A1c over 12 months
Time Frame: Baseline, 6 weeks, 6 months, 12 months
Baseline, 6 weeks, 6 months, 12 months
Change from baseline quality of life over 12 months
Time Frame: Baseline, 6 weeks, 6 months, 12 months
Baseline, 6 weeks, 6 months, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Margaret Grey, DrPH, Yale School of Nursing
  • Principal Investigator: Robin Whittemore, PhD, Yale School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112009416

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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