Clinical trial NCT00717223: A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
Official title: A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: Diabetes
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Literacy
Glycemic control
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-07-17
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with diabetes attending clinic followup at Texas Children's Hospital

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.

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.

Eligibility 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.

Primary outcomes:
measure: Literacy levels and HbA1c
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Diabetes Clinic, Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rubina A Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hassan K, Heptulla RA. Glycemic control in pediatric type 1 diabetes: role of caregiver literacy. Pediatrics. 2010 May;125(5):e1104-8. doi: 10.1542/peds.2009-1486. Epub 2010 Apr 5.