A Pilot Study of Personalized Medicine for Pediatric Asthma
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Personalized Medicine for Pediatric Asthma|
- 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
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Personalized Care Plan
A personalized plan based on baseline clinic visit data
Other: Personalized Care Plan
We will develop a personalized plan based on info collected in the primary visit
Active Comparator: Control
This arm will be standard care
Other: Control Standard Care
This is the standard care arm
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681732
|United States, Pennsylvania|
|Penn State Hershey Children's Hospital|
|Hersey, Pennsylvania, United States, 17033|
|Principal Investigator:||Adam Spanier, MD, PhD, MPH||Milton S. Hershey Medical Center|