A Pilot Study of Personalized Medicine for Pediatric Asthma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Milton S. Hershey Medical Center.
Recruitment status was  Recruiting
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
  Purpose

A pilot study to test the feasibility of a personalized asthma care intervention.


Condition Intervention
Asthma
Other: Personalized Care Plan
Other: Control Standard Care

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681732

Contacts
Contact: Julie Vallati, LPN 717-531-5656

Locations
United States, Pennsylvania
Penn State Hershey Children's Hospital Recruiting
Hersey, Pennsylvania, United States, 17033
Principal Investigator: Adam Spanier, MD, PhD, MPH         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Adam Spanier, MD, PhD, MPH Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Adam Spanier, Assistant Professor of Pediatrics and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01681732     History of Changes
Other Study ID Numbers: 38403
Study First Received: September 5, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Asthma
child
pediatric

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014