AsthmaProject CURANCT01065883
The Community United to Challenge Asthma
A study testing community health worker and mailed information in people with Asthma, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- community health worker and mailed information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2012
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Puerto Rican
- In high school
- Have asthma
Who cannot join
- More than 18 years old
- In last year of school
- Mild intermittent or controlled asthma
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.
- Conditions
- Asthma
- Being tested
- community health worker, mailed information
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
community health workerBehavioural
community health workers will provide education in the home
mailed informationBehavioural
information will be mailed to the home on the same schedule as the experimental intervention
| Study group | Role | What they receive |
|---|---|---|
| community health worker | Experimental | community health workers will provide education in the home Receives: Behavioral: community health worker |
| mailed information | Active comparator | information will be mailed to the home on the same schedule as the experimental intervention Receives: Behavioral: mailed information |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma medication adherence
Measured: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
Secondary outcomes (1)
asthma trigger reduction
Measured: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly A. Martin, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065883
- Sponsor's protocol ID
- 1R21HL093346-01A1
- Acronym
- Project CURA
- Status last verified
- Aug 2012
- First submitted
- 1 Feb 2010
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J Asthma. 2015 Feb;52(1):59-70. doi: 10.3109/02770903.2014.950426. Epub 2014 Aug 27.
PubMed 25162304Martin MA, Thomas AM, Mosnaim G, Greve M, Swider SM, Rothschild SK. Home asthma triggers: barriers to asthma control in Chicago Puerto Rican children. J Health Care Poor Underserved. 2013 May;24(2):813-27. doi: 10.1353/hpu.2013.0073.
PubMed 23728047Martin MA, Olson D, Mosnaim G, Ortega D, Rothschild SK. Recruitment, asthma characteristics, and medication behaviors in Midwestern Puerto Rican youth: data from Project CURA. Ann Allergy Asthma Immunol. 2012 Aug;109(2):121-7. doi: 10.1016/j.anai.2012.06.005. Epub 2012 Jun 26.
PubMed 22840253
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Intervention for Pediatric Asthma Self-Management in Puerto Ricans
- ClinicalTrials.gov ID
- NCT01065883
- Acronym / sponsor ID
- Project CURA / 1R21HL093346-01A1
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Feb 2010 (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.
This study compares an asthma self-management intervention, delivered to the family and tailored to their needs and cultural beliefs, to standard asthma education on two risk factors for asthma exacerbations in high-risk Puerto Rican children in high school. The self-management intervention will be a series of home visits provided by Puerto Rican community health workers. During home visits, the family will be educated using a standard asthma Core Curriculum which is tailored to individual needs, strengths, and beliefs. Specific Aim 1 is to test the ability of this tailored community health worker self-management intervention to reduce home asthma triggers and increase medication adherence in Puerto Rican adolescents with asthma. Specific Aim 2 is to test if any changes in triggers and adherence associated with this intervention are sustained 8 months after the completion of the active intervention. Another goal of the study is to build community capacity for asthma management in the target high-risk community.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| community health worker | Experimental | Behavioral: community health workercommunity health workers will provide education in the home |
| mailed information | Active comparator | Behavioral: mailed informationinformation will be mailed to the home on the same schedule as the experimental intervention |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Puerto Rican
- In high school
- Have asthma
Key exclusion criteria (3 listed)
- More than 18 years old
- In last year of school
- Mild intermittent or controlled asthma
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 |
|---|---|---|
| community health workercommunity health workers will provide education in the home | Behavioural | community health worker |
| mailed informationinformation will be mailed to the home on the same schedule as the experimental intervention | Behavioural | mailed information |
Primary outcome
asthma medication adherence
Time frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
1 secondary outcome
asthma trigger reduction
Time frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)
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 15 Aug 2012.
- Derived from this study: PubMed 25162304Martin MA, Mosnaim GS, Olson D, Swider S, Karavolos K, Rothschild S. Results from a community-based trial testing a community health worker asthma intervention in Puerto Rican youth in Chicago. J Asthma. 2015 Feb;52(1):59-70. doi: 10.3109/02770903.2014.950426. Epub 2014 Aug 27.
- Derived from this study: PubMed 23728047Martin MA, Thomas AM, Mosnaim G, Greve M, Swider SM, Rothschild SK. Home asthma triggers: barriers to asthma control in Chicago Puerto Rican children. J Health Care Poor Underserved. 2013 May;24(2):813-27. doi: 10.1353/hpu.2013.0073.
- Derived from this study: PubMed 22840253Martin MA, Olson D, Mosnaim G, Ortega D, Rothschild SK. Recruitment, asthma characteristics, and medication behaviors in Midwestern Puerto Rican youth: data from Project CURA. Ann Allergy Asthma Immunol. 2012 Aug;109(2):121-7. doi: 10.1016/j.anai.2012.06.005. Epub 2012 Jun 26.
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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.
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 community health worker and mailed information in people with Asthma, run by Rush University Medical Center 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 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 15 Aug 2012. 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 medication adherence (time frame: before randomization, month 5 after randomization (post-intervention), month 12 after randomization (post-maintanance)). 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 NCT01065883, which also lists 3 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 15 Aug 2012.