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

Diabetes Mellitus, Type 1 Clinical Trial

— TeensConnect  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783327
• Other study ID #: 1112009416
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: January 6, 2016
• Start date: July 2012
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale University School of Nursing	New Haven	Connecticut
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline hemoglobin A1c over 12 months		Baseline, 6 weeks, 6 months, 12 months	No
Primary	Change from baseline quality of life over 12 months		Baseline, 6 weeks, 6 months, 12 months	No
Secondary	Change from baseline coping/Stress over 12 months	Coping/stress will be measured using the Perceived Stress Scale	Baseline, 6 weeks, 6 months, 12 months	No
Secondary	Change from baseline self-efficacy over 12 months	Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale	Baseline, 6 weeks, 6 months, 12 months	No
Secondary	Change from baseline problem-solving over 12 months	Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire	Baseline, 6 weeks, 6 months, 12 months	No
Secondary	Change from baseline self-management over 12 months	Self-management will be assessed using the Self-care Inventory (SCI)	Baseline, 6 weeks, 6 months, 12 months	No
Secondary	Costs	Costs will be assessed using financial and staff records	6 months	No
Secondary	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)	Baseline, 6 weeks, 6 months, 12 months	No