Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed) (YourWay)
This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00848705
First received: February 19, 2009
Last updated: January 31, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Adolescent Type 1 Diabetes |
Behavioral: YourWay Internet Intervention |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Adolescent Self-Management of Type 1 Diabetes: an Intervention |
Resource links provided by NLM:
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- Self-management behaviors [ Time Frame: End of intervention ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Self-management Problem solving [ Time Frame: end of study period ] [ Designated as safety issue: No ]
| Enrollment: | 72 |
| Study Start Date: | October 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Measurement Only |
Behavioral: YourWay Internet Intervention
The intervention is an 11 week program that teaches problem solving of barriers to self-management.
|
| Experimental: Internet Intervention |
Behavioral: YourWay Internet Intervention
The intervention is an 11 week program that teaches problem solving of barriers to self-management.
|
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
-
Contacts and Locations More Information
No publications provided
| Responsible Party: | Shelagh Mulvaney, PhD, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00848705 History of Changes |
| Other Study ID Numbers: | DK70026-01A2 |
| Study First Received: | February 19, 2009 |
| Last Updated: | January 31, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
type 1 diabetes, adolescent, self-management |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013