AsthmaPCCNCT01757002
Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
A study testing Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. in people with Asthma, run by Henry Ford Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Asthma
- What is being tested?
- Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Nov 2016
- 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
- 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
Who cannot join
- Inability to provide informed consent/assent
- Lack of physician diagnosis of asthma
- Other co-morbidities that make it impossible for the individual to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
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.
Read the detailed description
Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).
The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.
- Conditions
- Asthma
- Being tested
- Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management., Teens in the control group will receive generic, web-based asthma education.
- Keywords
- Urban adolescents, Acute asthma, Asthma, Computer tailoring, Web-based intervention, Puff City
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.Behavioural
Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
Teens in the control group will receive generic, web-based asthma education.Behavioural
Web-based, generic asthma management intervention delivered in 4 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Tailored asthma management program | Experimental | Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. Receives: 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. Receives: Behavioral: Teens in the control group will receive generic, web-based asthma education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
Comparison of ACT scores at 12 months after the randomization
Measured: 12 Months
Secondary outcomes (1)
Asthma Exacerbations/Functional Status
Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g. self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization.
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 posted28 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2015
- Study completionNov 2016
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 AsthmaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Augusta University, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Dr. Mei Lu, Henry Ford Health System
- Investigators
- Mei Lu, PhD, Principal investigator, Henry Ford Health SystemChristine Joseph, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757002
- Sponsor's protocol ID
- 1R01HL114981-01
- Other IDs
- 1R01HL114981-01
- Acronym
- PCC
- Status last verified
- Aug 2017
- First submitted
- 7 Dec 2012
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24607295
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
- ClinicalTrials.gov ID
- NCT01757002
- Acronym / sponsor ID
- PCC / 1R01HL114981-01
- Conditions
- Asthma
- Keywords
- Urban adolescents, Acute asthma, Asthma, Computer tailoring, Web-based intervention, Puff City
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- University of Michigan, Augusta University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Dec 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 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.
Detailed description
Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).
The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored asthma management program | Experimental | Behavioral: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. |
| Control | Active comparator | Behavioral: Teens in the control group will receive generic, web-based asthma education.Teens 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 (7 listed)
- 13-19 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:
Key exclusion criteria (3 listed)
- Inability to provide informed consent/assent
- Lack of physician diagnosis of asthma
- Other co-morbidities that make it impossible for the 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 |
|---|---|---|
| Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster. | Behavioural | Tailored asthma management program |
| Teens in the control group will receive generic, web-based asthma education.Web-based, generic asthma management intervention delivered in 4 sessions. | Behavioural | Control |
Primary outcome
Asthma Control Test (ACT)
Time frame: 12 Months
Comparison of ACT scores at 12 months after the randomization
1 secondary outcome
Asthma Exacerbations/Functional Status
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 9 Aug 2017.
- Derived from this study: PubMed 24607295Lu 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.
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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.
Mei Lu, PhD principal investigator
Henry Ford Health System
Christine Joseph, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. in people with Asthma, run by Henry Ford Health System at 1 site 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 7 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 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Asthma Control Test (ACT) (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 NCT01757002, 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 9 Aug 2017.