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Completed

NCT Number: NCT00717223

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

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.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Clinic, Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Literacy levels and HbA1c

    Time frame: 1 year

    look at literacy levels an HbA1c

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2008
Registry last updated
Jul 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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