NCT01695031

Brief Summary

The objective of this study is to determine the feasibility of conducting a randomized controlled trial to evaluate the effectiveness of an online, Emergency Department-initiated asthma management intervention designed to reduce asthma-related morbidity among urban teenagers aged 13-19 years with uncontrolled asthma. The study will examine issues around recruitment, participant compliance with the study protocol, Internet access, and attrition. Investigators will first develop a protocol for recruiting 13-19 year old patients with acute asthma into an ED-initiated pilot trial of an online asthma management program, describing recruitment and refusal rates. Investigators will measure participant compliance with the pilot study protocol including 4 online sessions and a 6 month survey. Investigators will also measure compliance of the participants parents at baseline and a six month follow up. Investigators will then use pilot study results to describe the intervention effect on selected outcomes including ED visits, asthma control as measured by Asthma Control Questionnaire, functional limitations, quality of life, and behavior change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

September 12, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

2.4 years

First QC Date

September 12, 2012

Last Update Submit

March 30, 2015

Conditions

Acute Asthma

Keywords

Urban adolescentsAcute asthmaEmergency departmentComputer tailoringWeb-based intervention

Outcome Measures

Primary Outcomes (1)

  • Emergency Department Visit

    Proportion of enrolled teens randomized to the treatment group who return to the ED with acute asthma compared to the proportion of enrolled teens randomized to the control group who return to the ED with acute asthma

    12 months

Secondary Outcomes (1)

  • Asthma Control Test (ACT)

    12 months

Other Outcomes (1)

  • Functional Status

    12 months

Study Arms (2)

Tailored asthma management program

EXPERIMENTAL

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

Behavioral: Tailored asthma management program

Generic web-based education

ACTIVE COMPARATOR

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

Behavioral: Generic web-based education

Interventions

Tailored asthma management programBEHAVIORAL

web-based, computer-tailored asthma management intervention delivered every week for 4 weeks

Tailored asthma management program
Generic web-based educationBEHAVIORAL

Generic, web-based asthma education

Generic web-based education

Eligibility Criteria

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

You may qualify if:

  • years of age
  • Physician diagnosis of acute asthma at the Emergency Department visit
  • Parent written informed consent
  • Teen written informed assent

You may not qualify if:

  • Inability to provide informed consent/assent
  • No physician diagnosis of asthma
  • Other co-morbidities that make it impossible for individual to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

  • Joseph CLM, Mahajan P, Stokes-Buzzelli S, Johnson DA, Duffy E, Williams R, Zhang T, Ownby DR, Considine S, Lu M. Pilot study of a randomized trial to evaluate a Web-based intervention targeting adolescents presenting to the emergency department with acute asthma. Pilot Feasibility Stud. 2017 Jun 21;4:5. doi: 10.1186/s40814-017-0147-6. eCollection 2018.

    PMID: 28649417DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christine LM Joseph, PhD, MPH

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 27, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

US(2)