Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611001045909
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
5/10/2011
Date last updated
16/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Identifying barriers to smoking cessation in rheumatoid arthritis
Scientific title
The identification of barriers to smoking cessation in rheumatoid arthritis by focus groups
Secondary ID [1] 262698 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 270402 0
Rheumatoid arthritis 270423 0
Condition category
Condition code
Inflammatory and Immune System 270544 270544 0 0
Rheumatoid arthritis
Mental Health 279099 279099 0 0
Addiction

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Focus groups will be undertaken to identify barriers to smoking cessation in patients with rheumatoid arthritis. Focus groups will be structured discussion groups lasting 2-3 hours. A varity of questionnaire will also be completed by each particpant including Health Assessmetn Questionnaire (HAQ), Arthritis Self-efficacy Scale, Percieved Stress Scale, Self efficacy scale, smoking history and the HADs depression and anxiety score. Participants will take part in one focus group and complete the questionnaires at the same time
Intervention code [1] 267059 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279739 0
Difference in questionaire results between groups of patients will be assessed using standard statistical methods
Timepoint [1] 279739 0
Single time of focus group
Secondary outcome [1] 279344 0
Differences bought out in discussion in focus groups between groups of patients will be assessed using standard statistical methods
Timepoint [1] 279344 0
TIme of focus group

Eligibility
Key inclusion criteria
I. Male or female, aged >18yrs, with a diagnosis of RA as defined by the 2010 ACR/EULAR Criteria for RA
II. Able and willing to give written informed consent and to adhere to the requirements of the study.
III. Current or past smoker.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to give informed consent

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2012
Actual
14/03/2012
Date of last participant enrolment
Anticipated
Actual
15/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 3746 0
New Zealand
State/province [1] 3746 0
Canterbury
Country [2] 3747 0
New Zealand
State/province [2] 3747 0
Otago

Funding & Sponsors
Funding source category [1] 267536 0
Government body
Name [1] 267536 0
Health Research Council of NZ
Country [1] 267536 0
New Zealand
Primary sponsor type
Individual
Name
Lisa Stamp
Address
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 266575 0
University
Name [1] 266575 0
University of Otago
Address [1] 266575 0
POBox 56
Dunedin 9054
Country [1] 266575 0
New Zealand
Other collaborator category [1] 252138 0
Charities/Societies/Foundations
Name [1] 252138 0
Arthritis New Zealand
Address [1] 252138 0
PO Box 10-020,The Terrace, Wellington, 6143
Country [1] 252138 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269492 0
Multiregional Ethics Committee
Ethics committee address [1] 269492 0
Ethics committee country [1] 269492 0
New Zealand
Date submitted for ethics approval [1] 269492 0
01/07/2011
Approval date [1] 269492 0
19/07/2011
Ethics approval number [1] 269492 0
MEC/11/06/061

Summary
Brief summary
Rheumatoid arthritis is a common chronic disease resulting in joint damage requiring joint replacement surgery, disability and increased mortality due to cardiovascular disease. Smoking has recently been shown to be a powerful environmental risk factor for onset of RA. Smoking also results in worse disease outcomes and reduces the efficacy of medications used to treat RA. These effects, together with the increase in cardiovascular deaths make smoking cessation the most important modifiable lifestyle factor in RA. Such lifestyle changes are particularly difficult for patients living with the stress of a painful chronic disease. This project will explore the knowledge and beliefs of patients with RA in relation to smoking as it affects their condition. Specific arthritis related factors that contribute to difficulties with smoking cessation will be explored. A RA-specific smoking cessation programme will then be developed based on the findings and piloted in patients with RA with the help of Arthritis New Zealand.
Trial website
Nil
Trial related presentations / publications
Aimer P, Stamp LK, Stebbings S, Valentino V, Cameron V and Treharne GT. Identifying Barriers to Smoking Cessation in Rheumatoid Arthritis. Arthritis Care Res 2015; 67(5); 607-15.
Public notes

Contacts
Principal investigator
Name 32922 0
Prof Lisa Stamp
Address 32922 0
Department of Medicine
P.O.Box 4345
Christchurch 8014
Country 32922 0
New Zealand
Phone 32922 0
+643640953
Fax 32922 0
Email 32922 0
lisa.stamp@cdhb.govt.nz
Contact person for public queries
Name 16169 0
Lisa Stamp
Address 16169 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 16169 0
New Zealand
Phone 16169 0
+64-3-364-0953
Fax 16169 0
+64-3-364-0935
Email 16169 0
lisa.stamp@cdhb.health.nz
Contact person for scientific queries
Name 7097 0
Lisa Stamp
Address 7097 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 7097 0
New Zealand
Phone 7097 0
+64-3-364-0953
Fax 7097 0
+64-3-364-0935
Email 7097 0
lisa.stamp@cdhb.health.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.