A Pilot Study of Personalized Medicine for Pediatric Asthma
NCT ID: NCT01681732
Last Updated: 2017-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2012-09-30
2014-08-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Personalized Care Plan
A personalized plan based on baseline clinic visit data
Personalized Care Plan
We will develop a personalized plan based on info collected in the primary visit
Control
This arm will be standard care
Control Standard Care
This is the standard care arm
Interventions
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Personalized Care Plan
We will develop a personalized plan based on info collected in the primary visit
Control Standard Care
This is the standard care arm
Eligibility Criteria
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Inclusion Criteria
* doctor diagnosed asthma -at least one asthma exacerbation in the previous year. -
Exclusion Criteria
6 Years
17 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Responsible Party
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Principal Investigators
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Adam Spanier, MD, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Milton S. Hershey Medical Center
Locations
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Penn State Hershey Children's Hospital
Hersey, Pennsylvania, United States
Countries
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Other Identifiers
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38403
Identifier Type: -
Identifier Source: org_study_id
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