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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teens-Connect
Planet D
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, Type 1, Self care, Coping skills, Adolescent, Internet, Intervention Studies, Chronic Disease

Eligibility Criteria

11 Years - 14 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Yale University School of Nursing
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Teens-Connect

Planet D

Arm Description

The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE.

Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes.

Outcomes

Primary Outcome Measures

Change from baseline hemoglobin A1c over 12 months
Change from baseline quality of life over 12 months

Secondary Outcome Measures

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

Full Information

First Posted
January 28, 2013
Last Updated
January 6, 2016
Sponsor
Yale University
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01783327
Brief Title
Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
Acronym
TeensConnect
Official Title
Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, Type 1, Self care, Coping skills, Adolescent, Internet, Intervention Studies, Chronic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teens-Connect
Arm Type
Experimental
Arm Description
The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE.
Arm Title
Planet D
Arm Type
Active Comparator
Arm Description
Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes.
Intervention Type
Behavioral
Intervention Name(s)
Teens-Connect
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Planet D
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline hemoglobin A1c over 12 months
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Change from baseline quality of life over 12 months
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Change from baseline coping/Stress over 12 months
Description
Coping/stress will be measured using the Perceived Stress Scale
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Change from baseline self-efficacy over 12 months
Description
Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Change from baseline problem-solving over 12 months
Description
Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Change from baseline self-management over 12 months
Description
Self-management will be assessed using the Self-care Inventory (SCI)
Time Frame
Baseline, 6 weeks, 6 months, 12 months
Title
Costs
Description
Costs will be assessed using financial and staff records
Time Frame
6 months
Title
Change from baseline quality adjusted life years over 12 months
Description
Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent)
Time Frame
Baseline, 6 weeks, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Grey, DrPH
Organizational Affiliation
Yale School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robin Whittemore, PhD
Organizational Affiliation
Yale School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Nursing
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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