NCT01757002

Brief Summary

The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
266

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable asthma

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

First Submitted

Initial submission to the registry

December 7, 2012

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 28, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

December 7, 2012

Last Update Submit

August 8, 2017

Conditions

Asthma

Keywords

Urban adolescentsAcute asthmaAsthmaComputer tailoringWeb-based interventionPuff City

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test (ACT)

    Comparison of ACT scores at 12 months after the randomization

    12 Months

Secondary Outcomes (1)

  • Asthma Exacerbations/Functional Status

    12 Months

Other Outcomes (2)

  • The Cost

    Up to 12 months

  • The Cost Effectiveness

    Up to 12 months

Study Arms (2)

Tailored asthma management program

EXPERIMENTAL

Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.

Behavioral: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.

Control

ACTIVE COMPARATOR

Teens in the control group will receive generic, web-based asthma education.

Behavioral: Teens in the control group will receive generic, web-based asthma education.

Interventions

Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.BEHAVIORAL

Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.

Tailored asthma management program
Teens in the control group will receive generic, web-based asthma education.BEHAVIORAL

Web-based, generic asthma management intervention delivered in 4 sessions.

Control

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Must be able to provide electronic assent and have consent from a parent/guardian if applicable
  • Diagnosis of asthma by meeting one of the following criteria within the last 12 months:
  • At least one emergency department diagnosis of asthma or
  • At least one acute inpatient encounter with asthma as the principal diagnosis or
  • At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
  • At least four asthma medications dispensed

You may not qualify if:

  • Inability to provide informed consent/assent
  • Lack of physician diagnosis of asthma
  • Other co-morbidities that make it impossible for the individual to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Lu M, Ownby DR, Zoratti E, Roblin D, Johnson D, Johnson CC, Joseph CL. Improving efficiency and reducing costs: Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program. Contemp Clin Trials. 2014 May;38(1):19-27. doi: 10.1016/j.cct.2014.02.008. Epub 2014 Mar 6.

    PMID: 24607295DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Mei Lu, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

  • Christine Joseph, PhD

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Biostatistician

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 28, 2012

Study Start

March 1, 2013

Primary Completion

May 1, 2015

Study Completion

November 1, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

US(1)