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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12612000750886
Ethics application status
Approved
Date submitted
11/07/2012
Date registered
13/07/2012
Date last updated
13/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development of a quality of life instrument specific to autoimmune bullous disease
Scientific title
The development of a quality of life instrument specific to autoimmune bullous disease: the Autoimmune Bullous Disease Quality of Life instrument (ABQOL)
Secondary ID [1] 280800 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of life in Autoimmune bullous disease 286861 0
Condition category
Condition code
Skin 287185 287185 0 0
Dermatological conditions
Public Health 287238 287238 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with clinically and histologically diagnosed autoimmune bullous disease will participate in the development of a disease specific quality of life instrument. They will express the ways in which their blistering diseases affects their quality of life. Based on these responses, a pilot questionnaire will be developed. Patients will then be asked to complete the pilot questionnaire once. Statistical analyses will be completed on the responses to determine whether the questionnaire is a statistically sound.
Intervention code [1] 285231 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287479 0
The development of a quality of life instrument specific to autoimmune bullous disease. Once this instrument has been developed and if it is found to be statistically sound, it will be used by other researchers when evaluating quality of life in patients with blistering diseases.
Timepoint [1] 287479 0
Patient recruitment will cease once approximately 70 patients have been recruited and have completed the pilot questionnaire. This will mark the end of the patient recruitment process and occur at the end of the trial period. Once this target has been reached, statistical review of the results will be completed
Secondary outcome [1] 298256 0
N/A
Timepoint [1] 298256 0
N/A

Eligibility
Key inclusion criteria
Clinically and histologically diagnosed autoimmune bullous disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Limited fluency in English

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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/05/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285597 0
Self funded/Unfunded
Name [1] 285597 0
Dedee Murrell
Country [1] 285597 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australasian Blistering Diseases Foundation
Address
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 284429 0
University
Name [1] 284429 0
University of New South Wales Independent Learning Program
Address [1] 284429 0
Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country [1] 284429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287598 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [1] 287598 0
Ethics committee country [1] 287598 0
Australia
Date submitted for ethics approval [1] 287598 0
Approval date [1] 287598 0
Ethics approval number [1] 287598 0

Summary
Brief summary
The purpose of this project is to develop a quality of life instrument specific to autoimmune bullous disease. Patients with clinically and histologically diagnose autoimmune bullous disease will be recruited and interviewed regarding the ways their disease affects their quality of life. Based on these responses, a pilot questionnaire will be developed and given to 70 patients. Statistical analysis will then be performed based on the results of these questionnaires to determine whether the instrument is statistically sound or not. If it is validated, the instrument can then be used as a tool to measure quality of life in patients with autoimmune blistering skin diseases.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34411 0
Address 34411 0
Country 34411 0
Phone 34411 0
Fax 34411 0
Email 34411 0
Contact person for public queries
Name 17658 0
Professor Dedee Murrell
Address 17658 0
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country 17658 0
Australia
Phone 17658 0
+61-2-9113-2543
Fax 17658 0
Email 17658 0
[email protected]
Contact person for scientific queries
Name 8586 0
Professor Dedee Murrell
Address 8586 0
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country 8586 0
Australia
Phone 8586 0
61-2-9113-2543
Fax 8586 0
Email 8586 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.