NCT01783327CompletedNot Applicable
Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 124
- Locations
- 4
- Primary Endpoint
- Change from baseline hemoglobin A1c over 12 months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 11 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with type 1 diabetes for at least 6 months
- •Age 11 to 14 years
- •English-speaking
- •Parent/guardian consent to participate in study
Exclusion Criteria
- •*Previous exposure to TEENCOPE and/or Managing Diabetes
Outcomes
Primary Outcomes
Change from baseline hemoglobin A1c over 12 months
Time Frame: 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
Secondary Outcomes
- Change from baseline coping/Stress over 12 months(Baseline, 6 weeks, 6 months, 12 months)
- Change from baseline quality adjusted life years over 12 months(Baseline, 6 weeks, 6 months, 12 months)
- Change from baseline problem-solving over 12 months(Baseline, 6 weeks, 6 months, 12 months)
- Change from baseline self-efficacy over 12 months(Baseline, 6 weeks, 6 months, 12 months)
- Change from baseline self-management over 12 months(Baseline, 6 weeks, 6 months, 12 months)
- Costs(6 months)
Investigators
Study Sites (4)
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