AsthmaNCT01106326
A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
A study testing Intervention in people with Asthma, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational… Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Physician-diagnosed asthma
- Persistent asthma (criteria based on NHLBI guidelines).
- Age >12 and <15 years.
- Attending school in the Rochester City School District.
- Signed physician permission to enroll the child.
- Current prescription of a daily preventive asthma medication
- Parent or caregiver and the adolescent must consent to the intervention.
Who cannot join
- Inability to speak and understand English.
- No access to a working phone for follow-up surveys
- The family planning to leave the school district within fewer than 6 months.
- The teen having other significant medical conditions
- The teen having a diagnosed developmental condition per parent report.
- Adolescents in foster care or other situations in which consent cannot be obtained from a guardian.
- Adolescents that were previously enrolled in our School-Based Asthma Study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.
- Conditions
- Asthma
- Being tested
- Intervention
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Teens participating in this study will have:
- directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
- three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Teens participating in this study will have:
1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
2. three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications). Receives: Behavioral: Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Symptom-free Days Over Two Weeks
We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.
Measured: 2 and 4 month follow-up assessments
Secondary outcomes (1)
Additional Asthma Morbidity Measures
We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments.
Measured: 2 month, 4 month, final follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Jill Halterman, University of Rochester
- Investigators
- Jill S. Halterman, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106326
- Sponsor's protocol ID
- 28198
- Status last verified
- Jul 2014
- First submitted
- 16 Apr 2010
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7.
PubMed 24494626Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741.
PubMed 21599562
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
- ClinicalTrials.gov ID
- NCT01106326
- Acronym / sponsor ID
- 28198
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionTeens participating in this study will have: 1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study 2. three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications). |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Physician-diagnosed asthma
- Persistent asthma (criteria based on NHLBI guidelines).
- Age >12 and <15 years.
- Attending school in the Rochester City School District.
- Signed physician permission to enroll the child.
Key exclusion criteria (7 listed)
- Inability to speak and understand English.
- No access to a working phone for follow-up surveys
- The family planning to leave the school district within fewer than 6 months.
- The teen having other significant medical conditions
- The teen having a diagnosed developmental condition per parent report.
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 |
|---|---|---|
| InterventionTeens participating in this study will have: 1. directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study 2. three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications). | Behavioural | Intervention |
Primary outcome
Number of Symptom-free Days Over Two Weeks
Time frame: 2 and 4 month follow-up assessments
We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment.
1 secondary outcome
Additional Asthma Morbidity Measures
Time frame: 2 month, 4 month, final follow-up assessments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24494626Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7.
- Results publication: PubMed 21599562Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741.
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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.
Jill S. Halterman, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Asthma, run by University of Rochester 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 7 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 Aug 2014. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Symptom-free Days Over Two Weeks (time frame: 2 and 4 month follow-up assessments). 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 NCT01106326, which also lists 2 linked publications.
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 Aug 2014.