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A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00717223
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to see if a patient's ability (and/ or parent) to read, write, and do basic math problems affects blood sugar control in children with type 1 diabetes mellitus.

Condition or disease
Diabetes Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Detailed Description:
"Literacy" is defined as an individual's ability to read, write, and speak English, and compute and solve problems at levels of proficiency necessary to function on the job and in society, to achieve one's goals, and develop one's knowledge and potential, according to the National Literacy Act of 1991. The National Work Group on Health and Literacy reported that between 40 and 44 million persons in the United States have rudimentary literacy skills, and are unable to understand written materials that require only basic reading proficiency. Illiteracy has become an increasingly important problem, especially as it relates to healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2 diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for all individuals with diabetes who want to achieve successful health-related outcomes. Self care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C. Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem complications, increasing exponentially the burden on our healthcare system. Structured education of individuals tailored to combat poor literacy skills is imperative in helping these individuals achieve good glycemic control. Hence we would like to evaluate literacy in our clinic so appropriate educational material can be developed to help patient with T1DM who have low literacy.

Study Design

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
Study Start Date : June 2007
Primary Completion Date : April 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Parents with children with diabetes
parents who have children 18 or younger with diabetes


Outcome Measures

Primary Outcome Measures :
  1. Literacy levels and HbA1c [ Time Frame: 1 year ]
    look at literacy levels an HbA1c


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with diabetes attending clinic followup at Texas Children's Hospital
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus
  • Parent/ legal guardian must be present if child is less than 18 years of age.
  • Diagnosis of type 1 or type 2 diabetes mellitus must have been made at least 1 year earlier.
  • Parent/ legal guardian and/ or child must have completed all 3 mandatory diabetes education classes.
  • English and/or Spanish speaking only.

Exclusion Criteria:

  • Any form of mental retardation or cognitive disorder in parent/ legal guardian.
  • Mental retardation or cognitive disorder in a child who is in Grade 6 or higher.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717223


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rubina Heptulla, MD, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00717223     History of Changes
Other Study ID Numbers: H-21263
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rubina Heptulla, MD, Baylor College of Medicine:
Diabetes
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Literacy
Glycemic control

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases