Trial registered on ANZCTR


Trial ID
ACTRN12612000977875
Ethics application status
Approved
Date submitted
3/09/2012
Date registered
11/09/2012
Date last updated
13/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to determine patient specific and general beliefs towards medication and their treatment compliance to selected systemic therapies in chronic inflammatory diseases (ALIGN)
Scientific title
Multi-country, cross sectional study to determine patient specific and General beliefs towards medication and their treatment compliance to selected systemic therapies in chronic inflammatory diseases (IMID)
Secondary ID [1] 281204 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
ALIGN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 287309 0
Psoriasis 287315 0
Psoriatic Arthritis 287316 0
Ankylosing spondylitis 287317 0
Crohn's disease 287318 0
Ulcerative Colitis 287319 0
Inflammatory bowel disease. 287320 0
Condition category
Condition code
Inflammatory and Immune System 287645 287645 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 287646 287646 0 0
Rheumatoid arthritis
Oral and Gastrointestinal 287647 287647 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-interventional Questionnaire study. Looking at understanding better patient's attitudes, beliefs and risk concerns towards their systemic medication.
Duration of the study is a single visit to complete 4 questionnaires. The questionnaires will take 30-45 minutes to complete.
Intervention code [1] 285664 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287894 0
To describe patients' beliefs and risk concerns in patients with chronic inflammatory disaese toward their systemic medication via completion of validated questionnaires on one visit.
Questionnaires to be used in the study: Brief Illness Perception Questionnaire, Patient Health Questionnaire, Beliefs Medication questionnaire, Visual Analog Scale, and Morisky Medication Adherence Scale.
Timepoint [1] 287894 0
Each patient on one visit
Secondary outcome [1] 298998 0
To correlate patients' beliefs and risk concerns with disease characteristics via completion of validated questionnaires.
Questionnaires to be used in the study: Brief Illness Perception Questionnaire, Patient Health Questionnaire, Beliefs Medication questionnaire, Visual Analog Scale, and Morisky Medication Adherence Scale.
Timepoint [1] 298998 0
Each patient on one visit
Secondary outcome [2] 298999 0
To assess and describe beliefs about TNFinhibitor treatment as well as systemic treatments other than biologics via completion of validated questionnaires.
Questionnaires to be used in the study: Brief Illness Perception Questionnaire, Patient Health Questionnaire, Beliefs Medication questionnaire, Visual Analog Scale, and Morisky Medication Adherence Scale.
Timepoint [2] 298999 0
Each patient on one visit
Secondary outcome [3] 299000 0
To describe self reported compliance levels with TNFinhibitors and DMARDs, NSAIDs and IMM in patients with IMID as assessed by MMAS-4 and VAS for all treatments in each patient on one visit.
Timepoint [3] 299000 0
Each patient on one visit
Secondary outcome [4] 299009 0
To assess the correlation of patients beliefs about treatments with the respective treatment compliance levels and patient perception parameters like illness beliefs and depressive symptoms. using Brief illness Perception Questionnaire and Patient health Questionnaire on one visit.
Timepoint [4] 299009 0
Each patient on one visit
Secondary outcome [5] 299010 0
To describe patients beliefs about medicine in relation to treatment duration via completion of validated questionnaires on one visit.
Questionnaires to be used in the study: Brief Illness Perception Questionnaire, Patient Health Questionnaire, Beliefs Medication questionnaire, Visual Analog Scale, and Morisky Medication Adherence Scale.
Timepoint [5] 299010 0
Each patient on one visit

Eligibility
Key inclusion criteria
Female/male
18 years or over
Patients with Immune Mediated Inflammatory Disorders as diagnosed by a rheumatologist, gastroenterologist or dermatologist.
On current treatment with systemic either conventional and/or biologic immuno-modulating and/or disease-modifying drugs.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not applicable

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Actual
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5703 0
2050
Recruitment postcode(s) [2] 5704 0
2298
Recruitment postcode(s) [3] 5705 0
4102
Recruitment postcode(s) [4] 5706 0
3128
Recruitment postcode(s) [5] 5707 0
6005
Recruitment postcode(s) [6] 5708 0
5000
Recruitment postcode(s) [7] 5709 0
3079
Recruitment postcode(s) [8] 5710 0
4000
Recruitment postcode(s) [9] 5711 0
2217
Recruitment postcode(s) [10] 5712 0
3084
Recruitment postcode(s) [11] 5713 0
5042
Recruitment postcode(s) [12] 5714 0
4560
Recruitment postcode(s) [13] 5715 0
2500
Recruitment postcode(s) [14] 5716 0
3144
Recruitment postcode(s) [15] 5717 0
2170
Recruitment outside Australia
Country [1] 4520 0
New Zealand
State/province [1] 4520 0
Canterbury
Country [2] 4521 0
New Zealand
State/province [2] 4521 0
Auckland
Country [3] 4522 0
New Zealand
State/province [3] 4522 0
Wellington
Country [4] 4523 0
New Zealand
State/province [4] 4523 0
Waikato

Funding & Sponsors
Funding source category [1] 285919 0
Commercial sector/Industry
Name [1] 285919 0
AbbVie Pty Ltd
Address [1] 285919 0
32-34 Lord St
Botany NSW 2019
Country [1] 285919 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AbbVie Pty Ltd
Address
32-34 Lord St
Botany NSW 2019
Country
Australia
Secondary sponsor category [1] 284750 0
None
Name [1] 284750 0
Address [1] 284750 0
Country [1] 284750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287948 0
Bellberry Ethics Committee
Ethics committee address [1] 287948 0
229 Greenhill Rd
Dulwich SA 5065
Ethics committee country [1] 287948 0
Australia
Date submitted for ethics approval [1] 287948 0
08/08/2012
Approval date [1] 287948 0
15/08/2012
Ethics approval number [1] 287948 0
2012-07-947

Summary
Brief summary
The aim of the ALIGN study is to better understand patient’s attitudes, beliefs and risks concerns towards their systemic medication.The ALIGN study deals with the collection of information only and is not designed for drug testing.
You will also be asked to complete four types of questionnaires and one visual analog scale which will take approximately 30 to 45 minutes. You will have the opportunity to seal your answered questionnaires in an envelope so that they are not disclosed to your treating doctor.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34653 0
Address 34653 0
Country 34653 0
Phone 34653 0
Fax 34653 0
Email 34653 0
Contact person for public queries
Name 17900 0
Andrew Weekes
Address 17900 0
32-34 Lord St
Botany NSW 2019
Country 17900 0
Australia
Phone 17900 0
+61 2 93849900
Fax 17900 0
Email 17900 0
andrew.weekes@abbott.com
Contact person for scientific queries
Name 8828 0
Andrew Weekes
Address 8828 0
32-34 Lord St
Botany NSW 2019
Country 8828 0
Australia
Phone 8828 0
+61 2 93849900
Fax 8828 0
Email 8828 0
andrew.weekes@abbott.com