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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01735448




Registration number
NCT01735448
Ethics application status
Date submitted
23/11/2012
Date registered
28/11/2012

Titles & IDs
Public title
Improving Health for Aboriginal People Through Tobacco Related Research
Scientific title
Advancing the Understanding of Barriers and Facilitators for Tobacco Prevention, Cessation Treatments, Doctor Visits for Related Illnesses and Health Research for Aboriginal Australians
Secondary ID [1] 0 0
AHREC 04-12-472
Secondary ID [2] 0 0
04-12-472
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Focus group
Other interventions - One-on-one interviews
Other interventions - Survey

Aboriginal smoker, male, Adelaide - Focus group: Aboriginal smoker, male from Adelaide

Aboriginal smoker, female, Adelaide - Focus group: Aboriginal smoker, female, from Adelaide

Aboriginal ex/non-smoker, male, Adelaide - Focus group: Aboriginal ex/non-smoker, male, from Adelaide

Aboriginal ex/non-smoker, female, Adelaide - Focus group: Aboriginal ex/non-smoker, female, from Adelaide

Healthcare workers, Adelaide - Focus group: Healthcare workers who are based in Adelaide and work with Aboriginal patients

Healthcare workers, Murray Bridge - Focus group: Healthcare workers who are based in Murray Bridge and work with Aboriginal patients

Aboriginal smoker, male, Murray Bridge - Focus group: Aboriginal smoker, male, from Murray Bridge

Aboriginal smoker, female, Murray Bridge - Focus group: Aboriginal smoker, female, from Murray Bridge

Aboriginal ex/non-smoker, male, Murray Bridge - Focus group: Aboriginal ex/non-smoker, male, from Murray Bridge

Aboriginal ex/non-smoker, female, Murray Bridge - Focus group: Aboriginal ex/non-smoker, female, from Murray Bridge

Key community stakeholders - One-on-one interviews with 10 key Aboriginal community stakeholders

Respiratory physicians - One-on-one interviews with 10 Respiratory physicians

Consultants and General Practitioners - One-on-one interviews with 10 consultants and/or GP's


Other interventions: Focus group
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.

Other interventions: One-on-one interviews
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

Other interventions: Survey
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Identify the barriers and facilitators for doctor visits by Aboriginal people
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities
Timepoint [3] 0 0
18 months

Eligibility
Key inclusion criteria
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

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Cannot speak English
* Cannot sign a consent
* Does not have the intellectual capacity required to respond to questions

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
The Basil Hetzel Institute for Translational Health Research - Adelaide
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [3] 0 0
Murray Mallee Community Health Service; Aboriginal Primary Health Care Unit - Murray Bridge
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
5253 - Murray Bridge

Funding & Sponsors
Primary sponsor type
Other
Name
The Queen Elizabeth Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Adelaide
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kristin V Carson, PhD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Available on request
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01735448