Clinical trial NCT01783327: Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
Official title: Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Self care
Coping skills
Adolescent
Internet
Intervention Studies
Chronic Disease
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2013-02-04
Enrollment: 124
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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 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

Primary outcomes:
measure: Change from baseline hemoglobin A1c over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
measure: Change from baseline quality of life over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
Secondary outcomes:
measure: Change from baseline coping/Stress over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
measure: Change from baseline self-efficacy over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
measure: Change from baseline problem-solving over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
measure: Change from baseline self-management over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
measure: Costs
timeFrame: 6 months
measure: Change from baseline quality adjusted life years over 12 months
timeFrame: Baseline, 6 weeks, 6 months, 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Nursing
state: Connecticut
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Yale School of Nursing
name: Margaret Grey, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Nursing
name: Robin Whittemore, PhD
role: PRINCIPAL_INVESTIGATOR
References: