Back to resultsAdolescent Self-Management of Type 1 Diabetes: an Intervention (Completed) (YourWay)
Primary Purpose
Adolescent Type 1 Diabetes
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
YourWay Internet Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Adolescent Type 1 Diabetes focused on measuring type 1 diabetes, adolescent, self-management
Eligibility Criteria
Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent -
Exclusion Criteria: Any sensory deficits that would preclude seeing or hearing.
-
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Measurement Only
Internet Intervention
Arm Description
Outcomes
Primary Outcome Measures
Self-management behaviors
Secondary Outcome Measures
Self-management Problem solving
Full Information
NCT ID
NCT00848705
First Posted
February 19, 2009
Last Updated
January 31, 2011
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00848705
Brief Title
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)
Acronym
YourWay
Official Title
Adolescent Self-Management of Type 1 Diabetes: an Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goals of this R21 exploratory pilot and feasibility study were to: 1) design an Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test that intervention in a small randomized trial to establish technical feasibility, intervention acceptability, and competence in completing the necessary recruitment and research procedures. Although not powered to detect statistically significant changes, possible outcomes of this study include improvements in problem-solving, coping, and self-management behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Type 1 Diabetes
Keywords
type 1 diabetes, adolescent, self-management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Measurement Only
Arm Type
Active Comparator
Arm Title
Internet Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
YourWay Internet Intervention
Intervention Description
The intervention is an 11 week program that teaches problem solving of barriers to self-management.
Primary Outcome Measure Information:
Title
Self-management behaviors
Time Frame
End of intervention
Secondary Outcome Measure Information:
Title
Self-management Problem solving
Time Frame
end of study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent -
Exclusion Criteria: Any sensory deficits that would preclude seeing or hearing.
-
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)
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