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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848705

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37240
Sponsors and Collaborators
  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 July 20, 2014