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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Tailored asthma management program | Experimental | Teens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management Receives: Behavioral: Tailored asthma management program |
| Generic web-based education | Active comparator | Teens 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.
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)
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.
- First posted27 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AsthmaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Children's Hospital of Michigan, Augusta University
- Responsible party
- Principal investigator, Christine Joseph, Henry Ford Health System
- Investigators
- Christine LM Joseph, PhD, MPH, Principal investigator, Henry Ford Health System
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an ED-initiated Online Asthma Management Program for Urban Teens (Puff City-ED)
- ClinicalTrials.gov ID
- NCT01695031
- Acronym / sponsor ID
- PuffCityED / 1R34HL109296-01A1
- Conditions
- Acute Asthma
- Keywords
- Urban adolescents, Acute asthma, Emergency department, Computer tailoring, Web-based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- University of Michigan, Children's Hospital of Michigan, Augusta University
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored asthma management program | Experimental | Behavioral: Tailored asthma management programTeens randomized to the experimental arm will receive 4 sessions of web-based, tailored asthma management |
| Generic web-based education | Active comparator | Behavioral: Generic web-based educationTeens in the control group will receive generic, web-based asthma education. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 13-19 years of age
- Physician diagnosis of acute asthma at the Emergency Department visit
- Parent written informed consent
- Teen written informed assent
Key exclusion criteria (3 listed)
- Inability to provide informed consent/assent
- No physician diagnosis of asthma
- Other co-morbidities that make it impossible for individual to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored asthma management programweb-based, computer-tailored asthma management intervention delivered every week for 4 weeks | Behavioural | Tailored asthma management program |
| Generic web-based educationGeneric, web-based asthma education | Behavioural | Generic web-based education |
Primary outcome
Emergency Department Visit
Time frame: 12 months
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
1 secondary outcome
Asthma Control Test (ACT)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Derived from this study: PubMed 28649417Joseph 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.
Related trials for Acute Asthma
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruitingPhase 3
A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations
Asthma
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
Asthma Acute
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine LM Joseph, PhD, MPH principal investigator
Henry Ford Health System
2 sites in 1 country: see every site and its status.
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.