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Acute AsthmaPuffCityEDNCT01695031

Feasibility of an ED Initiated Online Asthma Management Program for Urban Teens

A study testing Tailored asthma management program and Generic web-based education in people with Acute Asthma, run by Henry Ford Health System at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 19 years
Conditions the study is for
Acute Asthma
What is being tested?
Tailored asthma management program and Generic web-based education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesUnited States
Study dates
Oct 2012to Mar 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 13-19 years of age
  • Physician diagnosis of acute asthma at the Emergency Department visit
  • Parent written informed consent
  • Teen written informed assent

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Feasibility of an ED-initiated Online Asthma Management Program for Urban Teens (Puff City-ED)

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.

Read the detailed description

Participating emergency departments include Henry Ford Main, Henry Ford Fairlane, and Detroit Medical Center Children's hospital. Eligible teens will be 13-19 years of age. (Including 19 year olds in the the proposed sample means the data is comparable to age categories used by many federal agencies). Eligibility criteria include: a physician diagnosis of acute asthma at the ED visit and parent and teen written informed consent/assent. Eligibility criteria can be confirmed with the help of the ED nursing staff as some teens presenting with symptoms of acute asthma, may receive an asthma diagnosis for the first time in the ED. Using the investigator's data from the school-based trial of Puff City, investigators observed that 12.9% (20/155) of teens reporting an ED visit at baseline also reported no physician diagnosis. This is used as an approximation of the number of participants in the ED pilot that may be newly diagnosed. Teens previously enrolled in the school-based version of Puff City will not be eligible to participate in this pilot. Eligible teens are approached by a recruiter during down time in the ER (while waiting during receiving treatment or while waiting to be discharged). A study recruiter will provide the teen with an enrollment packet that includes an informational brochure (SD 1), a consent (SD 2), and an assent form (SD 3). The recruiter will go through these materials with the parents and teens and answer any questions they may have about the program. The recruited teens who enroll are randomized to either treatment or control. Both groups will be asked to complete an online baseline questionnaire before leaving the ED. An example of this questionnaire has been included with this application (SD 4). Once the baseline questionnaire is finished, teens will then be completing 4 online sessions of web-based asthma education on their own time on a computer with Internet access. Control group will receive commercial websites such as those sponsored by the American Lung Association; the American Academy of Allergy, Asthma and Immunology; the Asthma and Allergy Foundation, and others. Treatment group receives the 4 online, tailored educational sessions. Teens will be encouraged to complete the 4 sessions within 90 days, with a minimum of 7 days between sessions to allow for behavior change. To regulate dosage, control participants receive a "time expired" message after 30 minutes of browsing; this time limit is commensurate with the estimated time needed to complete a tailored session. Teens will also be asked to complete a 6-month follow-up survey (SD 5).Parents/Guardians of the enrolled teens will also be asked to complete a baseline questionnaire and a follow-up at 6 months (SD 6-7) in the form of a telephone interview with a trained interviewer.

In YR1 investigators will develop the recruitment protocol, hire and train recruiters, and establish a study database. Investigators will get on the agenda of CHM ED staff meetings to orient clinic staff to the intervention, obtain input/feedback, discuss logistics, address concerns, and answer questions about the project. Prior to recruitment Investigators will develop signage about the study (as appropriate) for the ED. Recruitment will start in month six of YR1, with at least two practice runs of the protocol. In YR2, investigators will continue recruitment and begin 6 month follow-up surveys. Recruitment will end in the fall of YR2 leaving 6-8 months for completion of follow-up, analysis and write-up. At the end of YR1 and again at the end of YR2, investigators will conduct short, qualitative interviews with ED and research staff to ensure identification of issues, barriers, and obstacles to conducting a trial of an ED-initiated version of Puff City.

Conditions
Acute Asthma
Being tested
Tailored asthma management program, Generic web-based education
Keywords
Urban adolescents, Acute asthma, Emergency department, Computer tailoring, Web-based intervention
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored asthma management programBehavioural

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

  • Generic web-based educationBehavioural

    Generic, web-based asthma education

Study groups in NCT01695031
Study groupRoleWhat they receive
Tailored asthma management programExperimentalTeens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management
Receives: Behavioral: Tailored asthma management program
Generic web-based educationActive comparatorTeens in the control group will receive generic, web-based asthma education.
Receives: Behavioral: Generic web-based education

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (1)
  1. Asthma Control Test (ACT)

    Comparison of ACT scores at 12 months post-baseline by randomization group

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01695031
Sponsor's protocol ID
1R34HL109296-01A1
Acronym
PuffCityED
Status last verified
Mar 2015
First submitted
12 Sep 2012
Last updated
1 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28649417

Questions about this trial

What is this clinical trial studying?

A study testing Tailored asthma management program and Generic web-based education in people with Acute Asthma, run by Henry Ford Health System at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emergency Department Visit (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01695031, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.

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