A Pilot Study of Personalized Medicine for Pediatric Asthma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01681732|
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : April 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Other: Personalized Care Plan Other: Control Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Pilot Study of Personalized Medicine for Pediatric Asthma|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||August 29, 2014|
|Actual Study Completion Date :||August 29, 2014|
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
- number of symptom free days over the course of the study [ Time Frame: 3 months ]measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|