NCT01783327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

January 28, 2013

Last Update Submit

January 6, 2016

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1Self careCoping skillsAdolescentInternetIntervention StudiesChronic Disease

Outcome Measures

Primary Outcomes (2)

  • Change from baseline hemoglobin A1c over 12 months

    Baseline, 6 weeks, 6 months, 12 months

  • Change from baseline quality of life over 12 months

    Baseline, 6 weeks, 6 months, 12 months

Secondary Outcomes (6)

  • Change from baseline coping/Stress 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 problem-solving 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

  • +1 more secondary outcomes

Study Arms (2)

Teens-Connect

EXPERIMENTAL

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

Behavioral: Teens-Connect

Planet D

ACTIVE COMPARATOR

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

Behavioral: Planet D

Interventions

Teens-ConnectBEHAVIORAL

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.

Teens-Connect
Planet DBEHAVIORAL

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.

Planet D

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • \*Previous exposure to TEENCOPE and/or Managing Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University School of Nursing

New Haven, Connecticut, 06519, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Chronic Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Margaret Grey, DrPH

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

  • Robin Whittemore, PhD

    Yale School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

February 4, 2013

Study Start

July 1, 2012

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Locations

US(2)