AsthmaNCT00728169
Developing Asthma Interventions Using Community Based Research
An observational study of Asthma, run by Meharry Medical College at 1 site in United States.
Trial summary
The purpose of this study is to identify community resources and challenges in improving the health of community members with asthma. The primary goal of this project is to use Community-Based Participatory Research methodology to develop interventions aimed at improving asthma management in high-risk African American… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2009
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African-American, 18 years and older
Who may be able to join
- Self-identified African-American, 18 yrs. or older, resident of Davidson County, Tennessee at least 1 year.
Who cannot join
- Under 18 yrs. of age
- Non-African American
- Non-English speaking
- Do not reside in Davidson County, Tennessee
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Developing an Effective Asthma Intervention Using CBPR Methods
The purpose of this study is to identify community resources and challenges in improving the health of community members with asthma.
The primary goal of this project is to use Community-Based Participatory Research methodology to develop interventions aimed at improving asthma management in high-risk African American asthmatics. This "ground-up" longterm approach has never been tested before in asthmatics. The primary goal of this study will be accomplished with four specific aims:
Read more
Aim 1. Conduct focus groups to identify barriers to asthma management in the target population.
Aim 2. Use a community advisory board (CAB) consisting of participants selected from the various focus groups to gather information about solutions for the above barriers.
Aim 3. Use the information from the CAB to develop an intervention to improve asthma self management behaviors in the target population.
Aim 4. Refine the developed intervention based on feedback from focus groups conducted in Aim 1.
Read the detailed description
Volunteer will be asked to respond to several questions that address their perceptions about asthma. Volunteers will also be asked to discuss their beliefs about asthma. Everyone in the group will be given an opportunity to answer questions. Volunteers can decide that they no longer want to participate in the group discussion at any time.
The discussion will last from 1.5 - 2 hours. The focus group discussion will have a maximum of 10 people.
We will be audio and video taping the discussion so that we do not miss any information that volunteers share with us. The audio and video tapes will not be shared with anyone outside our staff.
Volunteer participation in this study is voluntary and there will be no negative consequences if volunteers decide not to participate. Volunteers are also free to withdraw from this study at any time. Withdrawal or refusal to participate will not affect health care services or other rights.
- Conditions
- Asthma
- Keywords
- Asthma, Focus Group, Community Based Participatory Research
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Use information from Community Based Participatory Research to develop an intervention to improve asthma self management behaviors.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJul 2009
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
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Investigators
- David S Trochtenberg, MD, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728169
- Sponsor's protocol ID
- 020715JEM13314
- Other IDs
- P20RR011792
- Status last verified
- Sep 2009
- First submitted
- 31 Jul 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Developing an Effective Asthma Intervention Using CBPR Methods
- ClinicalTrials.gov ID
- NCT00728169
- Acronym / sponsor ID
- 020715JEM13314
- Conditions
- Asthma
- Keywords
- Asthma, Focus Group, Community Based Participatory Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Aug 2008 (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 community resources and challenges in improving the health of community members with asthma.
The primary goal of this project is to use Community-Based Participatory Research methodology to develop interventions aimed at improving asthma management in high-risk African American asthmatics. This "ground-up" longterm approach has never been tested before in asthmatics. The primary goal of this study will be accomplished with four specific aims:
Aim 1. Conduct focus groups to identify barriers to asthma management in the target population.
Aim 2. Use a community advisory board (CAB) consisting of participants selected from the various focus groups to gather information about solutions for the above barriers.
Aim 3. Use the information from the CAB to develop an intervention to improve asthma self management behaviors in the target population.
Aim 4. Refine the developed intervention based on feedback from focus groups conducted in Aim 1.
Detailed description
Volunteer will be asked to respond to several questions that address their perceptions about asthma. Volunteers will also be asked to discuss their beliefs about asthma. Everyone in the group will be given an opportunity to answer questions. Volunteers can decide that they no longer want to participate in the group discussion at any time.
The discussion will last from 1.5 - 2 hours. The focus group discussion will have a maximum of 10 people.
We will be audio and video taping the discussion so that we do not miss any information that volunteers share with us. The audio and video tapes will not be shared with anyone outside our staff.
Volunteer participation in this study is voluntary and there will be no negative consequences if volunteers decide not to participate. Volunteers are also free to withdraw from this study at any time. Withdrawal or refusal to participate will not affect health care services or other rights.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African-American, 18 years and older
Key inclusion criteria (1 listed)
- Self-identified African-American, 18 yrs. or older, resident of Davidson County, Tennessee at least 1 year.
Key exclusion criteria (4 listed)
- Under 18 yrs. of age
- Non-African American
- Non-English speaking
- Do not reside in Davidson County, Tennessee
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
Use information from Community Based Participatory Research to develop an intervention to improve asthma self management behaviors.
Time frame: 2 years
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 18 Sep 2009.
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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.
David S Trochtenberg, MD principal investigator
Meharry Medical College
1 site 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 Meharry Medical College 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 1 inclusion and 4 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 18 Sep 2009. 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?
Use information from Community Based Participatory Research to develop an intervention to improve asthma self management behaviors. (time frame: 2 years). 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 18 Sep 2009.