A Pilot Study of Personalized Medicine for Pediatric Asthma

This study is currently recruiting participants.
Verified September 2012 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
Adam Spanier, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01681732
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012

September 5, 2012
September 7, 2012
September 2012
September 2013   (final data collection date for primary outcome measure)
number of symptom free days over the course of the study [ Time Frame: 3 months ] [ Designated as safety issue: No ]
measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms
Same as current
Complete list of historical versions of study NCT01681732 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Pilot Study of Personalized Medicine for Pediatric Asthma
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Asthma
  • Other: Personalized Care Plan
    We will develop a personalized plan based on info collected in the primary visit
  • Other: Control Standard Care
    This is the standard care arm
  • Experimental: Personalized Care Plan
    A personalized plan based on baseline clinic visit data
    Intervention: Other: Personalized Care Plan
  • Active Comparator: Control
    This arm will be standard care
    Intervention: Other: Control Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 6-17 years
  • doctor diagnosed asthma -at least one asthma exacerbation in the previous year. -

Exclusion Criteria:

-Children with other coexistent pulmonary diseases such as chronic lung disease and cystic fibrosis will be excluded.

Both
6 Years to 17 Years
No
Contact: Julie Vallati, LPN 717-531-5656
United States
 
NCT01681732
38403
No
Adam Spanier, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Adam Spanier, MD, PhD, MPH Penn State Hershey Medical Center
Milton S. Hershey Medical Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP