Ability to Cope With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00206362
First received: September 14, 2005
Last updated: September 11, 2015
Last verified: September 2015
  Purpose
The purpose of this study is to learn about the relationship that exists between coping skills and blood glucose control. In addition to this, we will study the effect of type 1 diabetes on coping skills in different age groups, genders, ethnicities, socioeconomic groups, and the duration of diabetes.

Condition Phase
Depression
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Ongoing Management of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Enrollment: 100
Study Start Date: July 2004
Study Completion Date: April 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Coping with type 1 diabetes can be very difficult. Type 1 diabetes is a very unique chronic disease because it requires constant attention to several responsibilities such as daily glucose monitoring, multiple daily insulin doses, and strict diet and exercise. Several studies have shown that increased rates of poorer glucose control are a result of struggling to cope with type 1 diabetes. This may be due to the fact that many type 1 diabetics experience a feeling of exhaustion, or "burnout," after a certain period of time due to an overwhelming amount of responsibility.

In our study we would like to determine how children's ability to cope with diabetes affects glucose control. By completing several questionnaires, we can analyze different kinds of coping skills through a complex scoring system. These scores will then be analyzed in comparison to your glucose control using HbA1c.

  Eligibility

Ages Eligible for Study:   8 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of diabetes clinic, Texas Children's Hospital.
Criteria

Inclusion Criteria:

  • Subjects must be type 1 diabetic
  • English/spanish speaking
  • The legal guardian must be present.

Exclusion Criteria:

  • Non-cognitive or mentally ill
  • Under the age of 8.0 years
  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: NCT00206362

Locations
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Texas Children's Hospital
Investigators
Principal Investigator: Rubina A Heptulla, MD Baylor College of Medicine
  More Information

Responsible Party: Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00206362     History of Changes
Other Study ID Numbers: 16040 
Study First Received: September 14, 2005
Last Updated: September 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Depression
Socioeconomic status
Type 1 diabetes mellitus
Children
Adolescents

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 26, 2016