A pilot study of time use, quality of life, and clinical outcomes in pediatric chronic disease

Study ID
STU 022014-034

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Contact
Jamie Becker
214/456-7000
Jamie.Becker@childrens.com

Principal Investigator
Jamie Becker, Ph.D.

Summary

The study is a single-center, interview and survey-based, cross-sectional examination of the associations between time required for completion of medical treatments, quality of life, and clinical status. The main independent variable will be time use for medical treatments. The main dependent variables will be adherence, quality of life, and clinical indicators of health status. The enrollment goal is 50 subjects. The study duration will be 2 years.

Participant Eligibility

1. Age 6 years to 18 years, inclusive
2. Presence of an adult care giver who is authorized to provide consent
2. Have a diagnosis of cystic fibrosis and/or diabetes mellitus.
Cystic fibrosis is based on the results of sweat chloride testing or identification of mutations in the CFTR gene.
Diabetes mellitus is defined by the diagnostic criteria of the American Diabetes Association and generally requires one or more of the following, occurring with typical symptoms, or confirmed by repeat testing:
1. Random or 2 hour glucose on oral glucose tolerance test >= 200 mg/dL
2. Fasting glucose >= 125 mg/dL
3. HbA1c >= 6.5%