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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717223
• Other study ID #: H-21263
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: July 19, 2016
• Start date: June 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Diabetes Clinic, Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Literacy levels and HbA1c	look at literacy levels an HbA1c	1 year	No