Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000072516
Ethics application status
Approved
Date submitted
21/02/2006
Date registered
21/02/2006
Date last updated
21/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an interactive audiovisual computer program educating patients with rheumatoid arthritis starting treatment with methotrexate: a randomized controlled trial.
Scientific title
Evaluation of an interactive audiovisual computer program educating patients with rheumatoid arthritis starting treatment with methotrexate: a randomized controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 1036 0
Condition category
Condition code
Inflammatory and Immune System 1113 1113 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An audiovisual computer program that educates patients with rheumatoid arthritis about methotrexate in addition to standard care. The information in the computer program is derived from a review of the literature and consultation with rheumatologists. The duration of the program is 15-20 minutes. The patients will be administered the computer program within a week of being started on methotrexate by their rheumatologist. Standard care is define as information provided verbally to the patient at the time of methotrexate commencement by their rheumatologist +/- written information provided at the discretion of the rheumatologist or pharmacist. Patients will be followed up for 6 months.
Intervention code [1] 910 0
Other interventions
Comparator / control treatment
Standard care alone. Standard care is define as information provided verbally to the patient at the time of methotrexate commencement by their rheumatologist +/- written information provided at the discretion of the rheumatologist or pharmacist. Patients will be followed up for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 1483 0
Patient knowledge assessed using a questionnaire
Timepoint [1] 1483 0
At 6 weeks, 3 months and 6 months post commencement of methotrexate.
Secondary outcome [1] 2665 0
Health assessment questionnaire (HAQ) and pain score
Timepoint [1] 2665 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [2] 2666 0
Rheumatoid arthritis self-efficacy scale (RASE)
Timepoint [2] 2666 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [3] 2667 0
Assessment of quality of life (AQoL)
Timepoint [3] 2667 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [4] 2668 0
Spielberger state and trait anxiety scale (STAI)
Timepoint [4] 2668 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [5] 2669 0
Kessler psychological distress scale
Timepoint [5] 2669 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [6] 2670 0
Methotrexate related adverse events
Timepoint [6] 2670 0
Assessed at 6 weeks, 3 months and 6 months.
Secondary outcome [7] 2671 0
Treatment cessation or failure and compliance.
Timepoint [7] 2671 0
Assessed at 6 weeks, 3 months and 6 months.

Eligibility
Key inclusion criteria
Patients with a diagnosis of rheumatoid arthritis based on assessment by a rheumatologist, starting treatment with methotrexate for the first time and attending one of the participating rheumatology centres for follow up.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they are non English speaking and/or reading, are hearing or visually impaired to a degree that would preclude use of the computer program or are unlikly to comply with follow up.

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)
central randomization by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization following stratification for treating rheumatologist using computer generated table of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1217 0
University
Name [1] 1217 0
University of Melbourne Australian Postgraduate Award
Country [1] 1217 0
Australia
Primary sponsor type
Hospital
Name
Department of Rheumatology Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 1075 0
None
Name [1] 1075 0
none
Address [1] 1075 0
Country [1] 1075 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2551 0
Melbourne Health HREC
Ethics committee address [1] 2551 0
Ethics committee country [1] 2551 0
Australia
Date submitted for ethics approval [1] 2551 0
Approval date [1] 2551 0
Ethics approval number [1] 2551 0
2006.040

Summary
Brief summary
The aim of this trial is to improve communication of information provided to patients with rheumatoid arthritis who are starting treatment with methotrexate.
All outcomes will be measured by a blinded assessor (not the treating rheumatologist). The patients will also be blinded in that they will not be aware of the trial at the time that they receive the educational intervention and will not be informed that their knowledge will be tested until they attend for the 6 week review at which time the patient knowledge questionnaire will be administered under supervision.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36204 0
Address 36204 0
Country 36204 0
Phone 36204 0
Fax 36204 0
Email 36204 0
Contact person for public queries
Name 10099 0
Dr Sabina Ciciriello
Address 10099 0
Rheumatology Department
Royal Melbourne Hospital
c/o Post Office
Grattan St
Parkville VIC 3050
Country 10099 0
Australia
Phone 10099 0
+61 3 93427634
Fax 10099 0
Email 10099 0
[email protected]
Contact person for scientific queries
Name 1027 0
Dr Sabina Ciciriello
Address 1027 0
Rheumatology Department
Royal Melbourne Hospital
c/o Post Office
Grattan St
Parkville VIC 3050
Country 1027 0
Australia
Phone 1027 0
+61 3 93427634
Fax 1027 0
Email 1027 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
No additional documents have been identified.