NCT01681732

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2014

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2 years

First QC Date

September 5, 2012

Last Update Submit

March 31, 2017

Conditions

Asthma

Keywords

Asthmachildpediatric

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (2)

Personalized Care Plan

EXPERIMENTAL

A personalized plan based on baseline clinic visit data

Other: Personalized Care Plan

Control

ACTIVE COMPARATOR

This arm will be standard care

Other: Control Standard Care

Interventions

Personalized Care PlanOTHER

We will develop a personalized plan based on info collected in the primary visit

Personalized Care Plan
Control Standard CareOTHER

This is the standard care arm

Control

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Children's Hospital

Hersey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Adam Spanier, MD, PhD, MPH

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 10, 2012

Study Start

September 1, 2012

Primary Completion

August 29, 2014

Study Completion

August 29, 2014

Last Updated

April 4, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)