Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Rubina Heptulla, MD, Baylor College of Medicine Identifier:
First received: July 16, 2008
Last updated: July 19, 2016
Last verified: July 2016
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.

Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes

Resource links provided by NLM:

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Literacy levels and HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    look at literacy levels an HbA1c

Enrollment: 110
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Parents with children with diabetes
parents who have children 18 or younger with diabetes

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.

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

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
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 identifier: NCT00717223

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rubina Heptulla, MD, Principal Investigator, Baylor College of Medicine Identifier: NCT00717223     History of Changes
Other Study ID Numbers: H-21263 
Study First Received: July 16, 2008
Last Updated: July 19, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Baylor College of Medicine:
Type 1 diabetes mellitus
Type 2 diabetes mellitus
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 processed this record on October 21, 2016