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A Pilot Study of Personalized Medicine for Pediatric Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized Care Plan
Control Standard Care
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, child, pediatric

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Penn State Hershey Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalized Care Plan

Control

Arm Description

A personalized plan based on baseline clinic visit data

This arm will be standard care

Outcomes

Primary Outcome Measures

number of symptom free days over the course of the study
measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms

Secondary Outcome Measures

Full Information

First Posted
September 5, 2012
Last Updated
March 31, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01681732
Brief Title
A Pilot Study of Personalized Medicine for Pediatric Asthma
Official Title
A Pilot Study of Personalized Medicine for Pediatric Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 29, 2014 (Actual)
Study Completion Date
August 29, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, child, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personalized Care Plan
Arm Type
Experimental
Arm Description
A personalized plan based on baseline clinic visit data
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This arm will be standard care
Intervention Type
Other
Intervention Name(s)
Personalized Care Plan
Intervention Description
We will develop a personalized plan based on info collected in the primary visit
Intervention Type
Other
Intervention Name(s)
Control Standard Care
Intervention Description
This is the standard care arm
Primary Outcome Measure Information:
Title
number of symptom free days over the course of the study
Description
measured as the number of days during the 2 weeks before the follow-up interview with no asthma symptoms
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Spanier, MD, PhD, MPH
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Children's Hospital
City
Hersey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Pilot Study of Personalized Medicine for Pediatric Asthma

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