Asthma Clinical Trial
Official title:
A Pilot Study of Personalized Medicine for Pediatric Asthma
A pilot study to test the feasibility of a personalized asthma care intervention.
There are two arms in this study. The control arm of the trial will involve the current
standard primary care asthma management, and the intervention arm will involve personalized
asthma management.
Inclusion criteria include: 1) child age 6-17 years, 2) doctor diagnosed asthma, 3) at least
one asthma exacerbation in the previous year. Children with other coexistent pulmonary
diseases such as chronic lung disease and cystic fibrosis will be excluded.
The period of participation will be three months for each participant. After screening, each
participant will have an initial clinic visit. During this baseline visit, the investigators
will collect DNA by taking a saliva sample, the investigators will conduct spirometry, and
the investigators will survey the families regarding household level environmental
exposures, demographics, and other key variables. The participant will be randomly assigned
to a study arm at the end of the baseline visit. The data gathered at the baseline visit
will be used to develop a management plan. The investigators will mail a plan to the
participant and the primary care provider within a couple weeks of the baseline visit. The
investigators will then discuss the plan with the participant via phone. Both groups will
receive a plan which MAY be used to guide asthma care. Sample letters follow the protocol.
The intervention group will receive basic information on the skin testing, genetic testing,
and spirometry. The control group will not receive the genetic information. The control arm
will receive the genetic information at the end of the study follow up.
After the baseline visit, the participants will receive a monthly phone call for two months
to conduct a survey to assess our study outcomes and covariates. At the 3rd month
participants will return to the GCRC for a final clinic visit. During the final visit the
investigators will conduct our survey and spirometry and request permission for medical
record release.
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