Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001500347
Ethics application status
Not required
Date submitted
18/10/2017
Date registered
24/10/2017
Date last updated
24/10/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Performance of self-reported health status measures in usual care rheumatology clinics
Scientific title
Rasch analysis shows that Health Assessment Questionnaire II is a truly generic measure of physical functioning for rheumatic diseases: a cross-sectional study
Secondary ID [1] 293152 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic diseases 305128 0
Condition category
Condition code
Musculoskeletal 304451 304451 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 304504 304504 0 0
Rheumatoid arthritis
Inflammatory and Immune System 304505 304505 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Usual care. Participants completed a single page questionnaire consisting of the Pain 100mm visual analogue scale (VAS), Patient Global 100mm VAS, and HAQ-II (10 items). The questionnaire was completed immediately before the clinical consultation and the results were available to the clinician to assist with management discussions.
Intervention code [1] 299402 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303693 0
Health Assessment Questionnaire II was the primary instrument of interest. Rasch analysis was used to assess differential item functioning across different categories of disease.
Timepoint [1] 303693 0
Baseline
Secondary outcome [1] 339870 0
None
Timepoint [1] 339870 0
None

Eligibility
Key inclusion criteria
Completion of routine clinic self-report questionnaire. Any person who completed the self-report questionnaire at their clinic visit was eligible for the study. This essentially meant all rheumatology clinic attenders. There were no restrictions for disease type or number of prior clinic visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
Rasch analysis of HAQ-II to establish absence of condition-specific DIF.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/07/2004
Date of last participant enrolment
Anticipated
Actual
21/08/2008
Date of last data collection
Anticipated
Actual
21/08/2008
Sample size
Target
1000
Accrual to date
Final
1000
Recruitment outside Australia
Country [1] 9294 0
New Zealand
State/province [1] 9294 0
Wellington

Funding & Sponsors
Funding source category [1] 297779 0
Hospital
Name [1] 297779 0
Hutt Valley District health Board
Country [1] 297779 0
New Zealand
Primary sponsor type
Hospital
Name
Hutt Valley District Health Board
Address
Private Bag 31907
Lower Hutt
Wellington 5040
Country
New Zealand
Secondary sponsor category [1] 296815 0
None
Name [1] 296815 0
Address [1] 296815 0
Country [1] 296815 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 298838 0
Ethics committee address [1] 298838 0
Ethics committee country [1] 298838 0
Date submitted for ethics approval [1] 298838 0
Approval date [1] 298838 0
Ethics approval number [1] 298838 0

Summary
Brief summary
This study was to assess the usefulness of a commonly used health status questionnaire (HAQ-II). In particular it was to confirm that the questionnaire behaved in the same way across different diseases seen within general rheumatology clinic settings. Patients completed the questionnaire as part of their ordinary clinic visit and statistical analysis was used to confirm that it the items of the questionnaire behaved similarly for people with different diseases.
Trial website
Trial related presentations / publications
None
Public notes
Ethics Committee approval was waived under the standard operating procedure for the NZ Health and Disability Ethics Committee, since the study was minimal-risk observation of usual care where no study procedure occurred outside of usual care (including generation of questionnaire data).

Contacts
Principal investigator
Name 78398 0
A/Prof William Taylor
Address 78398 0
Department of Medicine
University of Otago Wellington
PO Box 7343
Wellington
New Zealand
Country 78398 0
New Zealand
Phone 78398 0
+6448061801
Fax 78398 0
Email 78398 0
will.taylor@otago.ac.nz
Contact person for public queries
Name 78399 0
A/Prof William Taylor
Address 78399 0
Department of Medicine
University of Otago Wellington
PO Box 7343
Wellington
New Zealand
Country 78399 0
New Zealand
Phone 78399 0
+6448061801
Fax 78399 0
Email 78399 0
will.taylor@otago.ac.nz
Contact person for scientific queries
Name 78400 0
A/Prof William Taylor
Address 78400 0
Department of Medicine
University of Otago Wellington
PO Box 7343
Wellington
New Zealand
Country 78400 0
New Zealand
Phone 78400 0
+6443899759
Fax 78400 0
Email 78400 0
will.taylor@otago.ac.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
SourceTitleYear of PublicationDOI
EmbaseRasch analysis suggests that health assessment questionnaire II is a generic measure of physical functioning for rheumatic diseases: A cross-sectional study.2018https://dx.doi.org/10.1186/s12955-018-0939-2
N.B. These documents automatically identified may not have been verified by the study sponsor.