Tobacco DependenceNCT01735448
Improving Health for Aboriginal People Through Tobacco Related Research
An observational study of Tobacco Dependence, run by The Queen Elizabeth Hospital at 3 sites in Australia.
Trial summary
Aim: To identify barriers and facilitators in the uptake of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held health priorities and barriers to research in Aboriginal Australians from the perspectives of: Aboriginal smokers and ex/non-smokers Aboriginal… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Focus group, One-on-one interviews and Survey
- How many people
- 16 participants
- Where
- 3 sitesAustralia
- Study dates
- Mar 2013to Apr 2016
- 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: Participants who agree to be involved in the focus groups will be recruited via existing community contacts (e.g., Aboriginal elders, leaders of community groups and doctors who support the planned research) in urban Adelaide and regional Murray Bridge. We also intend on actively recruiting through clinic visits made by our visiting respiratory clinicians. Copies of the participant information sheet and consent form will be disseminated via local healthcare workers to seek focus group volunteers and via existing contacts in health and by word of mouth for one-on-one interview participants. Survey participants will be recruited as per above methods in addition to use of delegate lists and mail outs.
Who may be able to join
- Male Smokers
- Willing to participate
- Identifies as an Aboriginal person
- Uses more than 10 cigarettes or cigarette equivalent per week
- Has lived in the relevant community for >12 months
- Female Smokers
Show all 35Show fewer
- Willing to participate
- Identifies as an Aboriginal person
- Uses more than 10 cigarettes or cigarette equivalent per week
- Has lived in the relevant community for >12 months
- Male Non/Ex Smokers
- Willing to participate
- Identifies as an Aboriginal person
- Has not used tobacco for >3 months
- Has lived in the relevant community for >12 months
- Female Non/Ex Smokers
- Willing to participate
- Identifies as an Aboriginal person
- Has not used tobacco for >3 months
- Has lived in the relevant community for >12 months
- Healthcare worker
- Willing to participate
- Has provided healthcare to people from Aboriginal people for at least 25% of employment hours over the past 12 months, or
- Has provided healthcare to people from Aboriginal people for at least 5 years of their working career
- Is a qualified healthcare worker
- GP's / Specialists
- Willing to participate
- Has provided clinical care to people from Aboriginal people over a 12 month period (at least one consult per week or equivalent)
- Is a qualified General Practitioner or,
- Is a qualified doctor specialising in one of the following disciplines: respiratory, vascular, neurology, oncology, cardiology
- Key Stakeholders
- Willing to participate
- Currently working/has worked in Aboriginal health as a primary focus of the position, or
- Is a community Elder, or
- Is influential in Aboriginal health/communities
Who cannot join
- Cannot speak English
- Cannot sign a consent
- Does not have the intellectual capacity required to respond to questions
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
The Basil Hetzel Institute for Translational Health Research
Adelaide, South Australia, 5011
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Murray Mallee Community Health Service; Aboriginal Primary Health Care Unit
Murray Bridge, South Australia, 5253
About this study
Official title: Advancing the Understanding of Barriers and Facilitators for Tobacco Prevention, Cessation Treatments, Doctor Visits for Related Illnesses and Health Research for Aboriginal Australians
Aim: To identify barriers and facilitators in the uptake of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held health priorities and barriers to research in Aboriginal Australians from the perspectives of:
- Aboriginal smokers and ex/non-smokers
- Aboriginal Healthcare workers
- Consultants/general practitioners, and
- Key stakeholders in Aboriginal health
Focus groups, one-on-one interviews and surveys will be conducted to provide information at the 'grass-roots' level including examinations into perceived differences in locally held beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs, to assist implementation of future tobacco cessation/prevention interventions and treatment of smoking related illnesses. This information can be used to improve the health of Aboriginal people by identifying inadequacies in current practices and highlighting what these are through the eyes of community members, healthcare workers, consultants/general practitioners and key stakeholders. We also intend on examining any facilitators that are identified as positive and working aspects of current initiatives e.g. community infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.
Read the detailed description
We will identify barriers and facilitators for the implementation of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, youth and smoking, community held health priorities and barriers to research through:
- Multiple focus groups held within 2 communities with Aboriginal smokers and ex/non-smokers, and
- Focus groups with healthcare workers serving these communities, and
- Qualitative one-on-one interviews with key stakeholders in Aboriginal communities
- Qualitative one-on-one interviews with specialists/doctors working with Aboriginal patients
- Surveys with all participants mentioned above
- Surveys with specialist groups including members of tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ)
Smoking cessation is one of the most important ways to improve the prognosis of patients with respiratory diseases. Despite being over represented in the burden of smoking related morbidity and mortality, very little methodologically rigorous research has been conducted to evaluate and/or enhance the uptake of smoking cessation pharmacotherapies and smoking prevention for Aboriginal Australians, as evident in our two recent (2012) Cochrane meta-analyses and through extensive consultation over the past two years with Aboriginal Elders, key stakeholders, researchers and experts throughout Australia. Moreover, many of the healthcare workers and some doctors on the frontline are reporting that they do not believe they have the skills or ability to offer smoking cessation/prevention initiatives to these patients, and perhaps more importantly, admit to the attitude of 'even if I did, it's not going to work, so why bother'.
In light of this gap in knowledge, our project relates specifically to understanding and improving the lung health of Aboriginal Australians, the cohort with the greatest burden of disease and lowest life expectancy, through qualitative analyses. A total of 10 focus groups, 30 one-on-one interviews and approximately 120 surveys (unless data saturation is reached sooner) will be carried out in collaboration with Aboriginal community involvement. The information obtained from these will provide an overall picture of the barriers and enablers from the perspectives of the various individuals involved, being:
- Aboriginal participants from urban, regional and rural cohorts (8 focus groups plus surveys)
- Aboriginal healthcare workers from urban, regional and rural cohorts (2 focus groups plus surveys)
- Respiratory consultants who see Aboriginal patients (10 one-on-one interviews plus surveys)
- Key stakeholders in Aboriginal health including Aboriginal liaison officers, Aboriginal health councils, Elders \& influential figures in communities (10 one-on-one interviews plus surveys)
- Medical Consultants who see Aboriginal patients (2 one-on-one interviews plus surveys from each of the following disciplines: General Practitioners, cardiology, neurology, oncology and vascular; total of 10, or until data saturation)
Triangulation will occur at multiple levels to improve credibility and dependability including: data collection (focus groups, interviews and surveys), investigators (minimum five investigators involved throughout various aspects of the study), data sources (multiple locations, communities and venues), analysis methods (Grounded theory and Triandis model of behavioural change).
In addition a detailed audit trail will be kept and all focus groups and interviews will undergo feedback (confirmation of accuracy and interpretation) by participants. Quasi-statistics will also be employed as part of the analysis methods.
- Conditions
- Tobacco Dependence
- Being tested
- Focus group, One-on-one interviews, Survey
- Keywords
- smoking cessation, tobacco, addiction, Aboriginal, youth, Indigenous, pharmacological, focus group, interview
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupOther
Initially, ten focus groups with an average sample size of 5-7 participants each will be performed in two communities within South Australia, one being Adelaide and the other Murray Bridge, this includes focus groups held with healthcare workers.
The proposed focus groups will be conducted by experienced mediators who have undertaken Aboriginal cultural awareness training and have experience in qualitative research methods. Both mediators have also been involved in all aspects of project development and consultation with Aboriginal Elders and key stakeholders since its conception.
We will be using topic guides (reviewed by Aboriginal Elders and researchers) that will be semi-structured with open-ended questions designed to encourage group discussion around smoking cessation and the use of pharmacotherapies in particular, in addition to other objectives identified during the consultation phase of this research.
One-on-one interviewsOther
One-on- one interviews will be held with both medical clinicians and key stakeholders and will be conducted by existing TQEH (The Queen Elizabeth Hospital), Clinical Practice Unit employees, experienced in qualitative research. Informed consent will be required and the interview will be audio taped to allow analysis of the qualitative data. All interviews will remain anonymous, unless the interviewee prefers to be named. In this case, they will be named in the acknowledgement section of all publications and presentations. Moderator guides have been developed and reviewed in the same process undergone by the focus group moderator guides
SurveyOther
A four page survey will be administered to all focus group and interview participants in addition to select cohorts including tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ). The survey will include demographic data, smoking history and current smoking status (questions related to smoking for current tobacco users include the Fagerstrom test for nicotine dependence, multiple Likert scales for cravings, motivation to quit, confidence etc.) and Likert scales examining perceptions, attitudes and knowledge about tobacco use, cessation, prevention, health and research in the Aboriginal setting.
| Study group | Role | What they receive |
|---|---|---|
| Aboriginal smoker, male, Adelaide | Focus group: Aboriginal smoker, male from Adelaide Receives: Other: Focus group; Other: Survey | |
| Aboriginal smoker, female, Adelaide | Focus group: Aboriginal smoker, female, from Adelaide Receives: Other: Focus group; Other: Survey | |
| Aboriginal ex/non-smoker, male, Adelaide | Focus group: Aboriginal ex/non-smoker, male, from Adelaide Receives: Other: Focus group; Other: Survey | |
| Aboriginal ex/non-smoker, female, Adelaide | Focus group: Aboriginal ex/non-smoker, female, from Adelaide Receives: Other: Focus group; Other: Survey | |
| Healthcare workers, Adelaide | Focus group: Healthcare workers who are based in Adelaide and work with Aboriginal patients Receives: Other: Focus group; Other: Survey | |
| Healthcare workers, Murray Bridge | Focus group: Healthcare workers who are based in Murray Bridge and work with Aboriginal patients Receives: Other: Focus group; Other: Survey | |
| Aboriginal smoker, male, Murray Bridge | Focus group: Aboriginal smoker, male, from Murray Bridge Receives: Other: Focus group; Other: Survey | |
| Aboriginal smoker, female, Murray Bridge | Focus group: Aboriginal smoker, female, from Murray Bridge Receives: Other: Focus group; Other: Survey | |
| Aboriginal ex/non-smoker, male, Murray Bridge | Focus group: Aboriginal ex/non-smoker, male, from Murray Bridge Receives: Other: Focus group; Other: Survey | |
| Aboriginal ex/non-smoker, female, Murray Bridge | Focus group: Aboriginal ex/non-smoker, female, from Murray Bridge Receives: Other: Focus group; Other: Survey | |
| Key community stakeholders | One-on-one interviews with 10 key Aboriginal community stakeholders Receives: Other: One-on-one interviews; Other: Survey | |
| Respiratory physicians | One-on-one interviews with 10 Respiratory physicians Receives: Other: One-on-one interviews; Other: Survey | |
| Consultants and General Practitioners | One-on-one interviews with 10 consultants and/or GP's Receives: Other: One-on-one interviews; Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations
Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of pharmacotherapies for smoking cessation significantly improves the probability of successful abstinence. Identification of the barriers and facilitators for tobacco cessation pharmacotherapies will be determined through these qualitative discussions and mixed method approaches
Measured: 18 months
Secondary outcomes (3)
Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth
Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of tobacco prevention initiatives significantly improves the probability of lower tobacco prevalence long-term. Identification of the barriers and facilitators for tobacco prevention initiatives will be determined through these qualitative discussions and mixed method approaches
Measured: 18 months
Identify the barriers and facilitators for doctor visits by Aboriginal people
Qualitative analysis (focus groups, one-on-one interviews and surveys). Regular doctor visits by Aboriginal people can significantly reduce the progression of chronic illnesses, improve quality of life and reduce health care costs. Identification of the barriers and facilitators for these doctor visits, particularly with Respiratory physicians, will be determined through these qualitative discussions and mixed method approaches
Measured: 18 months
Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities
Qualitative analysis (focus groups, one-on-one interviews and surveys). Research in Aboriginal populations are often lengthy and in many cases fail to achieve their objectives, often due to inappropriate methodology or a lack of consultation with Aboriginal Elders or key stakeholders research initiatives particularly related to tobacco and chronic illnesses will be determined through these qualitative discussions and mixed method approaches. In addition, we aim to identify health priorities identified by participants within the focus groups, one-on-one interviews and surveys that can be targeted for future research initiatives.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Queen Elizabeth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Adelaide
- Responsible party
- Principal investigator, Kristin Carson, The Queen Elizabeth Hospital
- Investigators
- Kristin V Carson, PhD, Principal investigator, University of AdelaideBrian J Smith, MBBS, PhD, Study director, The Queen Elizabeth HospitalAdrian J Esterman, PhD,MSc,BSc, Study director, University of South AustraliaMatthew J Peters, MBBS, PhD, Study director, Concord Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735448
- Sponsor's protocol ID
- 04-12-472
- Other IDs
- AHREC 04-12-472
- Status last verified
- Apr 2017
- First submitted
- 23 Nov 2012
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Available on request
Publications
Carson KV, Brinn MP, Labiszewski NA, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009325. doi: 10.1002/14651858.CD009325.pub2.
PubMed 22895988Carson KV, Brinn MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in Indigenous populations. Cochrane Database Syst Rev. 2012 Jan 18;1:CD009046. doi: 10.1002/14651858.CD009046.pub2.
PubMed 22258998
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Understanding of Barriers and Facilitators for Tobacco Prevention, Cessation Treatments, Doctor Visits for Related Illnesses and Health Research for Aboriginal Australians
- ClinicalTrials.gov ID
- NCT01735448
- Acronym / sponsor ID
- 04-12-472
- Conditions
- Tobacco Dependence
- Keywords
- smoking cessation, tobacco, addiction, Aboriginal, youth, Indigenous, pharmacological, focus group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Queen Elizabeth HospitalUniversity, hospital or other
- Collaborators
- University of Adelaide
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Nov 2012 (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.
Aim: To identify barriers and facilitators in the uptake of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held health priorities and barriers to research in Aboriginal Australians from the perspectives of:
- Aboriginal smokers and ex/non-smokers
- Aboriginal Healthcare workers
- Consultants/general practitioners, and
- Key stakeholders in Aboriginal health
Focus groups, one-on-one interviews and surveys will be conducted to provide information at the 'grass-roots' level including examinations into perceived differences in locally held beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs, to assist implementation of future tobacco cessation/prevention interventions and treatment of smoking related illnesses. This information can be used to improve the health of Aboriginal people by identifying inadequacies in current practices and highlighting what these are through the eyes of community members, healthcare workers, consultants/general practitioners and key stakeholders. We also intend on examining any facilitators that are identified as positive and working aspects of current initiatives e.g. community infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.
Detailed description
We will identify barriers and facilitators for the implementation of smoking cessation pharmacotherapies, tobacco prevention, doctor visits, youth and smoking, community held health priorities and barriers to research through:
- Multiple focus groups held within 2 communities with Aboriginal smokers and ex/non-smokers, and
- Focus groups with healthcare workers serving these communities, and
- Qualitative one-on-one interviews with key stakeholders in Aboriginal communities
- Qualitative one-on-one interviews with specialists/doctors working with Aboriginal patients
- Surveys with all participants mentioned above
- Surveys with specialist groups including members of tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ)
Smoking cessation is one of the most important ways to improve the prognosis of patients with respiratory diseases. Despite being over represented in the burden of smoking related morbidity and mortality, very little methodologically rigorous research has been conducted to evaluate and/or enhance the uptake of smoking cessation pharmacotherapies and smoking prevention for Aboriginal Australians, as evident in our two recent (2012) Cochrane meta-analyses and through extensive consultation over the past two years with Aboriginal Elders, key stakeholders, researchers and experts throughout Australia. Moreover, many of the healthcare workers and some doctors on the frontline are reporting that they do not believe they have the skills or ability to offer smoking cessation/prevention initiatives to these patients, and perhaps more importantly, admit to the attitude of 'even if I did, it's not going to work, so why bother'.
In light of this gap in knowledge, our project relates specifically to understanding and improving the lung health of Aboriginal Australians, the cohort with the greatest burden of disease and lowest life expectancy, through qualitative analyses. A total of 10 focus groups, 30 one-on-one interviews and approximately 120 surveys (unless data saturation is reached sooner) will be carried out in collaboration with Aboriginal community involvement. The information obtained from these will provide an overall picture of the barriers and enablers from the perspectives of the various individuals involved, being:
- Aboriginal participants from urban, regional and rural cohorts (8 focus groups plus surveys)
- Aboriginal healthcare workers from urban, regional and rural cohorts (2 focus groups plus surveys)
- Respiratory consultants who see Aboriginal patients (10 one-on-one interviews plus surveys)
- Key stakeholders in Aboriginal health including Aboriginal liaison officers, Aboriginal health councils, Elders \& influential figures in communities (10 one-on-one interviews plus surveys)
- Medical Consultants who see Aboriginal patients (2 one-on-one interviews plus surveys from each of the following disciplines: General Practitioners, cardiology, neurology, oncology and vascular; total of 10, or until data saturation)
Triangulation will occur at multiple levels to improve credibility and dependability including: data collection (focus groups, interviews and surveys), investigators (minimum five investigators involved throughout various aspects of the study), data sources (multiple locations, communities and venues), analysis methods (Grounded theory and Triandis model of behavioural change).
In addition a detailed audit trail will be kept and all focus groups and interviews will undergo feedback (confirmation of accuracy and interpretation) by participants. Quasi-statistics will also be employed as part of the analysis methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Aboriginal smoker, male, Adelaide | – | Other: Focus group, Other: SurveyFocus group: Aboriginal smoker, male from Adelaide |
| Aboriginal smoker, female, Adelaide | – | Other: Focus group, Other: SurveyFocus group: Aboriginal smoker, female, from Adelaide |
| Aboriginal ex/non-smoker, male, Adelaide | – | Other: Focus group, Other: SurveyFocus group: Aboriginal ex/non-smoker, male, from Adelaide |
| Aboriginal ex/non-smoker, female, Adelaide | – | Other: Focus group, Other: SurveyFocus group: Aboriginal ex/non-smoker, female, from Adelaide |
| Healthcare workers, Adelaide | – | Other: Focus group, Other: SurveyFocus group: Healthcare workers who are based in Adelaide and work with Aboriginal patients |
| Healthcare workers, Murray Bridge | – | Other: Focus group, Other: SurveyFocus group: Healthcare workers who are based in Murray Bridge and work with Aboriginal patients |
| Aboriginal smoker, male, Murray Bridge | – | Other: Focus group, Other: SurveyFocus group: Aboriginal smoker, male, from Murray Bridge |
| Aboriginal smoker, female, Murray Bridge | – | Other: Focus group, Other: SurveyFocus group: Aboriginal smoker, female, from Murray Bridge |
| Aboriginal ex/non-smoker, male, Murray Bridge | – | Other: Focus group, Other: SurveyFocus group: Aboriginal ex/non-smoker, male, from Murray Bridge |
| Aboriginal ex/non-smoker, female, Murray Bridge | – | Other: Focus group, Other: SurveyFocus group: Aboriginal ex/non-smoker, female, from Murray Bridge |
| Key community stakeholders | – | Other: One-on-one interviews, Other: SurveyOne-on-one interviews with 10 key Aboriginal community stakeholders |
| Respiratory physicians | – | Other: One-on-one interviews, Other: SurveyOne-on-one interviews with 10 Respiratory physicians |
| Consultants and General Practitioners | – | Other: One-on-one interviews, Other: SurveyOne-on-one interviews with 10 consultants and/or GP's |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who agree to be involved in the focus groups will be recruited via existing community contacts (e.g., Aboriginal elders, leaders of community groups and doctors who support the planned research) in urban Adelaide and regional Murray Bridge. We also intend on actively recruiting through clinic visits made by our visiting respiratory clinicians. Copies of the participant information sheet and consent form will be disseminated via local healthcare workers to seek focus group volunteers and via existing contacts in health and by word of mouth for one-on-one interview participants. Survey participants will be recruited as per above methods in addition to use of delegate lists and mail outs.
Key inclusion criteria (35 listed)
- Male Smokers
- Willing to participate
- Identifies as an Aboriginal person
- Uses more than 10 cigarettes or cigarette equivalent per week
- Has lived in the relevant community for >12 months
Key exclusion criteria (3 listed)
- Cannot speak English
- Cannot sign a consent
- Does not have the intellectual capacity required to respond to questions
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 |
|---|---|---|
| Focus groupInitially, ten focus groups with an average sample size of 5-7 participants each will be performed in two communities within South Australia, one being Adelaide and the other Murray Bridge, this includes focus groups held with healthcare workers. The proposed focus groups will be conducted by experienced mediators who have undertaken Aboriginal cultural awareness training and have experience in qualitative research methods. Both mediators have also been involved in all aspects of project development and consultation with Aboriginal Elders and key stakeholders since its conception. We will be using topic guides (reviewed by Aboriginal Elders and researchers) that will be semi-structured with open-ended questions designed to encourage group discussion around smoking cessation and the use of pharmacotherapies in particular, in addition to other objectives identified during the consultation phase of this research. | Other | Aboriginal ex/non-smoker, female, Adelaide, Aboriginal ex/non-smoker, female, Murray Bridge, Aboriginal ex/non-smoker, male, Adelaide, Aboriginal ex/non-smoker, male, Murray Bridge, Aboriginal smoker, female, Adelaide, Aboriginal smoker, female, Murray Bridge, Aboriginal smoker, male, Adelaide, Aboriginal smoker, male, Murray Bridge, Healthcare workers, Adelaide, Healthcare workers, Murray Bridge |
| One-on-one interviewsOne-on- one interviews will be held with both medical clinicians and key stakeholders and will be conducted by existing TQEH (The Queen Elizabeth Hospital), Clinical Practice Unit employees, experienced in qualitative research. Informed consent will be required and the interview will be audio taped to allow analysis of the qualitative data. All interviews will remain anonymous, unless the interviewee prefers to be named. In this case, they will be named in the acknowledgement section of all publications and presentations. Moderator guides have been developed and reviewed in the same process undergone by the focus group moderator guides | Other | Consultants and General Practitioners, Key community stakeholders, Respiratory physicians |
| SurveyA four page survey will be administered to all focus group and interview participants in addition to select cohorts including tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ). The survey will include demographic data, smoking history and current smoking status (questions related to smoking for current tobacco users include the Fagerstrom test for nicotine dependence, multiple Likert scales for cravings, motivation to quit, confidence etc.) and Likert scales examining perceptions, attitudes and knowledge about tobacco use, cessation, prevention, health and research in the Aboriginal setting. | Other | Aboriginal ex/non-smoker, female, Adelaide, Aboriginal ex/non-smoker, female, Murray Bridge, Aboriginal ex/non-smoker, male, Adelaide, Aboriginal ex/non-smoker, male, Murray Bridge, Aboriginal smoker, female, Adelaide, Aboriginal smoker, female, Murray Bridge, Aboriginal smoker, male, Adelaide, Aboriginal smoker, male, Murray Bridge, Consultants and General Practitioners, Healthcare workers, Adelaide, Healthcare workers, Murray Bridge, Key community stakeholders, Respiratory physicians |
Primary outcome
Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations
Time frame: 18 months
Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of pharmacotherapies for smoking cessation significantly improves the probability of successful abstinence. Identification of the barriers and facilitators for tobacco cessation pharmacotherapies will be determined through these qualitative discussions and mixed method approaches
3 secondary outcomes
Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth
Time frame: 18 months
Identify the barriers and facilitators for doctor visits by Aboriginal people
Time frame: 18 months
Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities
Time frame: 18 months
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 10 Apr 2017.
- Background: PubMed 22895988Carson KV, Brinn MP, Labiszewski NA, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009325. doi: 10.1002/14651858.CD009325.pub2.
- Background: PubMed 22258998Carson KV, Brinn MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in Indigenous populations. Cochrane Database Syst Rev. 2012 Jan 18;1:CD009046. doi: 10.1002/14651858.CD009046.pub2.
- Individual participant dataSharing planned: Yes. Available on request
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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.
Kristin V Carson, PhD principal investigator
University of Adelaide
Brian J Smith, MBBS, PhD study director
The Queen Elizabeth Hospital
Adrian J Esterman, PhD,MSc,BSc study director
University of South Australia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Dependence, run by The Queen Elizabeth Hospital at 3 sites in Australia.
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 35 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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?
Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations (time frame: 18 months). 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 NCT01735448, 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 10 Apr 2017.