Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001076864
Ethics application status
Approved
Date submitted
8/10/2012
Date registered
8/10/2012
Date last updated
19/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of smoking cessation in rheumatoid arthritis
Scientific title
Lifestyle interventions to aid smoking cessation in rheumatoid arthritis
Secondary ID [1] 281354 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 287575 0
smoking 287578 0
Condition category
Condition code
Musculoskeletal 287900 287900 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 287903 287903 0 0
Rheumatoid arthritis
Mental Health 287904 287904 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be contacted by arthritis educators from Arthritis New Zealand. Advice and support will be provided around 5 key areas - pain management, education, exercise, coping strategies and support. Telephone support will be given weekly for four weeks then at week 8. All interventions will be given in person or by phone. Patients may opt to take up some suggetsions given by the arthritis educators. Phone consultations will be 30-60minutes
Intervention code [1] 285814 0
Lifestyle
Intervention code [2] 285817 0
Behaviour
Comparator / control treatment
Standard of care - provision of Christchurch Hospital standard smoke stop advice
Control group
Active

Outcomes
Primary outcome [1] 288116 0
Smoking cessation will beassessed by subject self report
Timepoint [1] 288116 0
1, 3 and 6 months
Secondary outcome [1] 299454 0
reduction in smoking will beassessed by subject self report
Timepoint [1] 299454 0
1, 3 and 6 months
Secondary outcome [2] 307445 0
participants beliefs about effectiveness of smoking cessation intervention
Timepoint [2] 307445 0
15 months

Eligibility
Key inclusion criteria
Rheumatoid arthritis and smoker
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed using sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised allocation into the two groups in a 1:1 ratio will be made using a computer generated randomisation list. This list will be compiled prior to any randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/10/2012
Actual
26/11/2012
Date of last participant enrolment
Anticipated
Actual
20/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 4565 0
New Zealand
State/province [1] 4565 0
Christchurch

Funding & Sponsors
Funding source category [1] 286113 0
Government body
Name [1] 286113 0
Health research Council of New Zealand
Country [1] 286113 0
New Zealand
Primary sponsor type
Individual
Name
Lisa Stamp
Address
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 284925 0
University
Name [1] 284925 0
University of Otago
Address [1] 284925 0
P.O.Box 4345 Christchurch 8014
Country [1] 284925 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288158 0
HEDC
Ethics committee address [1] 288158 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288158 0
New Zealand
Date submitted for ethics approval [1] 288158 0
09/10/2012
Approval date [1] 288158 0
01/11/2012
Ethics approval number [1] 288158 0
12/STH/28

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. through focus groups with Ra smokers five key barriers to smoking cessation have been identified (pain, exercise, education, coping strategies and support). An intervention programme addressing these areas has been developed and will be piloted
Trial website
Trial related presentations / publications
1. Aimer P, Treharne GJ, Stebbings S, Frampton C, Cameron V, Kirby S and Stamp LK. Efficacy of a Rheumatoid Arthritis-Specific Smoking Cessation Programme; a Pilot Randomized Controlled Trial. Arthritis Care Res 2016 (In press).

2. Aimer P, Stamp LK, Stebbings S, Cameron V, Kirby S, Croft S, Treharne GJ. Developing a tailored smoking cessation intervention for rheumatoid arthritis patients. Muscolskelet Care 2016;14(1):2-14
Public notes

Contacts
Principal investigator
Name 34734 0
Prof Lisa Stamp
Address 34734 0
Department of Medicine
P.O.Box 4345
Christchurch 8011
New Zealand
Country 34734 0
New Zealand
Phone 34734 0
+6433640953
Fax 34734 0
Email 34734 0
[email protected]
Contact person for public queries
Name 17981 0
Mrs Pip Aimer
Address 17981 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 17981 0
New Zealand
Phone 17981 0
+64-3-364-0496
Fax 17981 0
Email 17981 0
[email protected]
Contact person for scientific queries
Name 8909 0
Prof Lisa Stamp
Address 8909 0
Department of Medicine
University of Otago, Christchurch
P.O.Box 4345
Christchurch 8014
Country 8909 0
New Zealand
Phone 8909 0
+64-3-3644-0953
Fax 8909 0
Email 8909 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a Rheumatoid Arthritis-Specific Smoking Cessation Program: A Randomized Controlled Pilot Trial.2017https://dx.doi.org/10.1002/acr.22960
N.B. These documents automatically identified may not have been verified by the study sponsor.