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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Robin Whittemore, Yale University
ClinicalTrials.gov Identifier:
NCT01783327
First received: January 28, 2013
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Behavioral: Teens-Connect
Behavioral: Planet D
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Change from baseline hemoglobin A1c over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change from baseline quality of life over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline coping/Stress over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Coping/stress will be measured using the Perceived Stress Scale

  • Change from baseline self-efficacy over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale

  • Change from baseline problem-solving over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire

  • Change from baseline self-management over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Self-management will be assessed using the Self-care Inventory (SCI)

  • Costs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Costs will be assessed using financial and staff records

  • Change from baseline quality adjusted life years over 12 months [ Time Frame: Baseline, 6 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent)


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783327

Locations
United States, Connecticut
Yale University School of Nursing
New Haven, Connecticut, United States, 06519
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Yale University
American Diabetes Association
Investigators
Principal Investigator: Margaret Grey, DrPH Yale School of Nursing
Principal Investigator: Robin Whittemore, PhD Yale School of Nursing
  More Information

No publications provided

Responsible Party: Robin Whittemore, Co-Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01783327     History of Changes
Other Study ID Numbers: 1-12-SAN-10
Study First Received: January 28, 2013
Last Updated: June 30, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Yale University:
Diabetes Mellitus, Type 1
Self care
Coping skills
Adolescent
Internet
Intervention Studies
Chronic Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014