Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000365763
Ethics application status
Approved
Date submitted
30/03/2013
Date registered
5/04/2013
Date last updated
5/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The development of a quality of life instrument specific to treatment effects in autoimmune bullous disease
Scientific title
The development of a quality of life instrument specific to the treatment effects in autoimmune bullous disease: the Treatment Autoimmune Bullous Disease Quality of Life instrument (TABQOL)
Secondary ID [1] 282212 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 288732 0
Condition category
Condition code
Skin 289088 289088 0 0
Dermatological conditions
Inflammatory and Immune System 289119 289119 0 0
Autoimmune diseases

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. Through the use of focus groups during one 2 hour interview process- they will express the ways in which the treatments and medications they take for 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. The period for focus groups, development of questionnaire and distribution of questionnaire will be initially 6 months.
Intervention code [1] 286828 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289198 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 treatment based quality of life in patients with blistering diseases.
Timepoint [1] 289198 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] 302018 0
Nil
Timepoint [1] 302018 0
Nil

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
Completed
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)
NSW

Funding & Sponsors
Funding source category [1] 286976 0
Self funded/Unfunded
Name [1] 286976 0
Prof Dedee Murrell
Country [1] 286976 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] 285765 0
University
Name [1] 285765 0
University of New South Wales Independent Learning Program
Address [1] 285765 0
Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country [1] 285765 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289026 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee
Ethics committee address [1] 289026 0
Ethics committee country [1] 289026 0
Australia
Date submitted for ethics approval [1] 289026 0
Approval date [1] 289026 0
Ethics approval number [1] 289026 0

Summary
Brief summary
The purpose of this project is to develop a quality of life instrument specific to the treatment effects in 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 38850 0
Prof Dedee Murrell
Address 38850 0
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country 38850 0
Australia
Phone 38850 0
+61291132543
Fax 38850 0
Email 38850 0
d.murrell@unsw.edu.au
Contact person for public queries
Name 38851 0
Prof Dedee Murrell
Address 38851 0
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country 38851 0
Australia
Phone 38851 0
+61291132543
Fax 38851 0
Email 38851 0
d.murrell@unsw.edu.au
Contact person for scientific queries
Name 38852 0
Prof Dedee Murrell
Address 38852 0
Department of Dermatology, St George Hospital, Gray Street, Kogarah, NSW, 2217
Country 38852 0
Australia
Phone 38852 0
+61291132543
Fax 38852 0
Email 38852 0
d.murrell@unsw.edu.au

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.