AsthmaNCT00094419
Complementary and Alternative Medicine Use in Low-Income African American and Caucasian Adults With Asthma
An observational study of Asthma, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
The purpose of this study is to identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Asthma
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Jun 2006
- Phase
- Observational
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician-diagnosed asthma with episodes that last for long periods of time
- Medicaid recipients
- Self-identify as African American or Caucasian
- Daily use of inhaled corticosteroids
- Able to speak English
- Have mental capacity to understand and participate in the study
Who cannot join
- Prisoners
- History of smoking at least ten packs of cigarettes per year
- Currently smoke more than one and a half packs of cigarettes per week
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Campus
Baltimore, Maryland, 21224
Presbyterian Medical Center at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Role of Complementary and Alternative Medicine (CAM), Folk Care and Faith-Based Approaches in the Home Management of Persistent Asthma in Low-Income African American and Caucasian Adults
The purpose of this study is to identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. The overall goal is to collect data that will increase understanding of health beliefs and behaviors in people with low-income backgrounds so that studies can be created that may help modify and improve patients' symptoms of asthma.
Read the detailed description
The rates of asthma-related deaths and disease are disproportionately high among African Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians use more CAM than African Americans, but the therapies utilized are different. This study will determine how well people with persistent asthma adhere to their treatment and whether the type and frequency of use of CAM affects treatment adherence.
Participants will begin this study by taking part in an interview about adherence to their current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing the interview, participant adherence to their ICS regimen will be monitored for 6 weeks. Depending on the type of ICS participants are taking, monitoring will be conducted either by participant self-reporting or electronic monitors that record the time and date of medication inhalation. Participant adherence will also be assessed at study completion.
- Conditions
- Asthma
- Keywords
- Complementary Therapies
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2004 (estimated)
- Study startNov 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Maureen George, PhD RN AE-C, Principal investigator, Johns Hopkins Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094419
- Sponsor's protocol ID
- F32AT002012-01
- Status last verified
- Aug 2008
- First submitted
- 18 Oct 2004
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Complementary and Alternative Medicine (CAM), Folk Care and Faith-Based Approaches in the Home Management of Persistent Asthma in Low-Income African American and Caucasian Adults
- ClinicalTrials.gov ID
- NCT00094419
- Acronym / sponsor ID
- F32AT002012-01
- Conditions
- Asthma
- Keywords
- Complementary Therapies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Nov 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Oct 2004 (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 identify the types of and frequency of use of complementary and alternative medicine (CAM) strategies among low-income Caucasian and African American adults with persistent asthma. The overall goal is to collect data that will increase understanding of health beliefs and behaviors in people with low-income backgrounds so that studies can be created that may help modify and improve patients' symptoms of asthma.
Detailed description
The rates of asthma-related deaths and disease are disproportionately high among African Americans compared to Caucasians. Surveys indicate that middle- and upper-income Caucasians use more CAM than African Americans, but the therapies utilized are different. This study will determine how well people with persistent asthma adhere to their treatment and whether the type and frequency of use of CAM affects treatment adherence.
Participants will begin this study by taking part in an interview about adherence to their current inhaled corticosteroids (ICS) regimen and their personal CAM use. After completing the interview, participant adherence to their ICS regimen will be monitored for 6 weeks. Depending on the type of ICS participants are taking, monitoring will be conducted either by participant self-reporting or electronic monitors that record the time and date of medication inhalation. Participant adherence will also be assessed at study completion.
Study design
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Physician-diagnosed asthma with episodes that last for long periods of time
- Medicaid recipients
- Self-identify as African American or Caucasian
- Daily use of inhaled corticosteroids
- Able to speak English
Key exclusion criteria (3 listed)
- Prisoners
- History of smoking at least ten packs of cigarettes per year
- Currently smoke more than one and a half packs of cigarettes per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 Aug 2008.
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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.
Maureen George, PhD RN AE-C principal investigator
Johns Hopkins Medical Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Center for Complementary and Integrative Health (NCCIH) 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 6 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 12 Aug 2008. 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.
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 12 Aug 2008.