AsthmaNCT01676896
Asthma in Central Texas Project
A study testing Asthma in-school class, Asthma Day Camp and Health Promotion in-school class in people with Asthma, run by University of Texas at Austin at 1 site in United States.
Trial summary
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Asthma in-school class, Asthma Day Camp and Health Promotion in-school class
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2014
- 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 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent reports the child has a diagnosis of asthma made by a medical provider;
- has had asthma symptoms in the previous 12 months;
- speaks either English or Spanish.
Who cannot join
- has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Enhancing Children's and Parents' Asthma Management
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.
Read the detailed description
Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).
- Conditions
- Asthma
- Being tested
- Asthma in-school class, Asthma Day Camp, Health Promotion in-school class
- Keywords
- children, asthma, quality of life, self-management
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma in-school classBehavioural
Also called Asthma Plan for Kids
Asthma Day CampBehavioural
Health Promotion in-school classBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Asthma in-school class | Experimental | Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner. Receives: Behavioral: Asthma in-school class |
| Asthma Day Camp | Experimental | The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes. Receives: Behavioral: Asthma Day Camp |
| Health Promotion in-school class | Sham comparator | The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise. Receives: Behavioral: Health Promotion in-school class |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absenteeism, End of Study
(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.
Measured: 12 months
Quality of Life, End of Study
Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
Measured: 12 months
Number of Days Hospitalized, During Study Year
Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.
Measured: 12 months
Emergency Department Visits, Study Year
Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
Measured: 12 months
Number of Asthma Hospitalizations Pre-Study Year
Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Measured: 12 months before baseline
Absenteeism Pre-study Year
(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.
Measured: 12 months before baseline
Number of Days in Hospital for Asthma, Pre-Study Year
Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Measured: 12 months before baseline
Number of Asthma Hospital Stays, During Study Year
Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.
Measured: 12 months
Emergency Department Visits, Pre-study Year
Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Measured: 12 months before baseline
Quality of Life, Pre-study Year
Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
Measured: 12 months before baseline
Secondary outcomes (16)
Asthma Self-management, Time 4
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 4, final measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Measured: Time 4, at 12 months
Home Asthma Management, Time 4, End of Study
Parent report of asthma preventive and treatment activities. Data collected at final study visit, Time 4. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Measured: Time 4 at 12 months
Metered Dose Inhaler Skill, Time 4
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 4 data visit.
Measured: Time 4 at 12 months
Medication Adherence, Time 4
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at final data point, Time 4.
Measured: Time 4 at 12 months
Asthma Self-management, Time 3
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 3 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Measured: Time 3 at 9 months
Asthma Self-management, Time 2
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the Time 2 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Measured: Time 2 at 5 months
Asthma Self-management, Time 1, Baseline
Child self-report of asthma preventive and management activities, collected at each of 4 time points. This is the baseline, Time 1 measure. Asthma Inventory for Children, 18-item scale, response scale 1-5, minimum score = 18, maximum score = 65, higher score = more frequent asthma self management behaviors.
Measured: Time 1, baseline
Home Asthma Management, Time 1, Baseline
Parent report of asthma preventive and treatment activities. Data are collected at study enrollment, Time 1, baseline visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Measured: Time 1, baseline
Home Asthma Management, Time 2.
Parent report of asthma preventive and treatment activities. Data collected at the time 2 visit. Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Measured: Time 2 at 5 months
Home Asthma Management, Time 3
Parent report of asthma preventive and treatment activities. Data collected at third time point (Time 3). Home Asthma Management scale, asthma preventive and asthma treatment behaviors performed by parent, response scale 1-5, scale range 16-70, higher scores = more frequent home asthma management behaviors.
Measured: Time 3 at 9 months
Metered Dose Inhaler Skill, Time 3
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at time 3 data visit.
Measured: Time 3 at 9 months
Metered Dose Inhaler Skill, Time 2
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at final, time 2 data visit.
Measured: Time 2 at 5 months
Metered Dose Inhaler Skill, Time 1
Observation score of child's skill in using a placebo metered dose inhaler (a teaching inhaler). Observation data recorded by trained data collectors. 8-item scale listing the steps to perform proper inhalation technique. Number of correct steps are summed. Higher score = better skill in using inhaler. Collected at enrollment visit, Time 1 data visit.
Measured: Time 1 at baseline
Medication Adherence, Time 1
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at study enrollment, Time 1.
Measured: Time 1 at baseline
Medication Adherence, Time 2
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 2 visit.
Measured: Time 2 at 5 months
Medication Adherence, Time 3
Parent report of their child remembering/forgetting to take medications. 4-item scale (forgot to take medicine, was careless in taking medicine, stopped taking medicine due to feeling better, stopped taking medicine due to feeling worse), dichotomous response scale (yes, no), sum of number of yes items. Range 0-4, higher score means worse adherence. Data are collected at Time 3 visit.
Measured: Time 3 at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startDec 2008
- Primary completionSep 2013
- Study completionNov 2014
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676896
- Sponsor's protocol ID
- R01NR007770
- Other IDs
- R01NR007770
- Status last verified
- Apr 2015
- First submitted
- 24 Aug 2012
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Children's and Parents' Asthma Management
- ClinicalTrials.gov ID
- NCT01676896
- Acronym / sponsor ID
- R01NR007770
- Conditions
- Asthma
- Keywords
- children, asthma, quality of life, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Dec 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 2 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Asthma is the most common chronic childhood illness and disproportionately affects children who are ethnic minorities and poor. Few studies of childhood asthma have been conducted with children who live in rural areas or have included Mexican American children in their samples. This study builds on the original R01NR007770 with findings that demonstrated the intervention could improve children's asthma self-management, asthma knowledge, metered dose inhaler skill, asthma severity, and parents' asthma management and access to care. In this competing continuation, the investigators added a third arm to the current research design with schools randomized into either an in-school asthma intervention, an in-school attention-control intervention, or an alternate intervention-delivery format of a single 5.5-hour asthma day camp. The tri-ethnic sample will be composed of 320 Mexican-American, African-American, and White rural school-aged children (grades 2-5) who have asthma and their parents. In addition, the investigators propose adding a non-invasive measure of chronic airway inflammation (exhaled nitric oxide) to assess the impact of changes in asthma management on airway inflammation. Families will be followed for a full year with data collection at baseline and at 1-month, 4-months, and 7-months after the intervention to assess improvement in children's asthma morbidity, asthma severity, airway inflammation, family asthma management and quality of life. Hypotheses (H): Children in the Camp-Workshop group and the School-Home group will demonstrate equivalent improvements, but greater improvements than the Attention-Control group in:(H1.1) their asthma severity and airway inflammation from the Time 1 assessment when compared to Time 4 assessment; (H1.2) office visits, ED visits, and hospitalizations for asthma, and absenteeism for the study year (Time 4) when compared to the pre-study year (Time 1); and (H1.4) Parents in the intervention arms will demonstrate sustained improvements in asthma caregiver's quality of life (QOL0 from the pre-study year (Time 1) to the end of the study year (Time 4) measurement, when compared to the Attention-Control group.
Detailed description
Families are recruited at the beginning of the school year (Time 1, October-November); parents consent and child assent obtained and baseline data collected in fall. The intervention is provided in December-January. Follow-up data are collected at February (Time 2), April (Time 3), and August (Time 4).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma in-school class | Experimental | Behavioral: Asthma in-school classProvided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner. |
| Asthma Day Camp | Experimental | Behavioral: Asthma Day CampThe asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes. |
| Health Promotion in-school class | Sham comparator | Behavioral: Health Promotion in-school classThe mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- parent reports the child has a diagnosis of asthma made by a medical provider;
- has had asthma symptoms in the previous 12 months;
- speaks either English or Spanish.
Key exclusion criteria (1 listed)
- has a significant co-morbidity that would preclude participation in classes (e.g., severe cerebral palsy, oxygen dependent conditions)
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 |
|---|---|---|
| Asthma in-school classAlso: Asthma Plan for Kids | Behavioural | Asthma in-school class |
| Asthma Day Camp | Behavioural | Asthma Day Camp |
| Health Promotion in-school class | Behavioural | Health Promotion in-school class |
Primary outcome
Absenteeism, End of Study
Time frame: 12 months
(Days absent/days enrolled)x100 = absenteeism. Using data provided by the school district at the end of the study year.
Quality of Life, End of Study
Time frame: 12 months
Self reported asthma-related quality of life. Outcome data were collected at end of study (Time 4). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
Number of Days Hospitalized, During Study Year
Time frame: 12 months
Number of days hospitalized for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalization days were summed for a total number at the end of the 12 months.
Emergency Department Visits, Study Year
Time frame: 12 months
Number of visits to Emergency Department for asthma. Data is obtained from parents at three time points (time 2, 3, and 4) and summed for total number of visits to the emergency department for asthma during the study year.
Number of Asthma Hospitalizations Pre-Study Year
Time frame: 12 months before baseline
Number of times hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Absenteeism Pre-study Year
Time frame: 12 months before baseline
(Days absent/days enrolled)x100 = absenteeism. Using data for the 12 months prior to study enrollment as the pre-study year. Data is provided by the participating school districts.
Number of Days in Hospital for Asthma, Pre-Study Year
Time frame: 12 months before baseline
Number of days hospitalized for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Number of Asthma Hospital Stays, During Study Year
Time frame: 12 months
Number of hospital admissions for asthma. Data were obtained from parent report at the second, third, and fourth data collection point. The number of hospitalizations were summed for a total number at the end of the 12 months.
Emergency Department Visits, Pre-study Year
Time frame: 12 months before baseline
Number of visits to Emergency Department for asthma. Data is obtained from parents for the pre-study year for the previous 12 months.
Quality of Life, Pre-study Year
Time frame: 12 months before baseline
Self reported asthma-related quality of life. Data were collected at study enrollment (time 1). The Pediatric Asthma Quality of Life scale. Minimum score 23 to maximum score of 115. A higher score indicates worse quality of life. Mean scale scores are computed.
16 secondary outcomes
Asthma Self-management, Time 4
Time frame: Time 4, at 12 months
Home Asthma Management, Time 4, End of Study
Time frame: Time 4 at 12 months
Metered Dose Inhaler Skill, Time 4
Time frame: Time 4 at 12 months
Medication Adherence, Time 4
Time frame: Time 4 at 12 months
Asthma Self-management, Time 3
Time frame: Time 3 at 9 months
Asthma Self-management, Time 2
Time frame: Time 2 at 5 months
Asthma Self-management, Time 1, Baseline
Time frame: Time 1, baseline
Home Asthma Management, Time 1, Baseline
Time frame: Time 1, baseline
Home Asthma Management, Time 2.
Time frame: Time 2 at 5 months
Home Asthma Management, Time 3
Time frame: Time 3 at 9 months
Metered Dose Inhaler Skill, Time 3
Time frame: Time 3 at 9 months
Metered Dose Inhaler Skill, Time 2
Time frame: Time 2 at 5 months
Metered Dose Inhaler Skill, Time 1
Time frame: Time 1 at baseline
Medication Adherence, Time 1
Time frame: Time 1 at baseline
Medication Adherence, Time 2
Time frame: Time 2 at 5 months
Medication Adherence, Time 3
Time frame: Time 3 at 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma in-school class, Asthma Day Camp and Health Promotion in-school class in people with Asthma, run by University of Texas at Austin 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 3 inclusion and 1 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 24 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 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. Some participants in this study may receive a placebo. 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 Apr 2015). 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?
Absenteeism, End of Study (time frame: 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2015.