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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00884728




Registration number
NCT00884728
Ethics application status
Date submitted
20/04/2009
Date registered
21/04/2009
Date last updated
21/04/2009

Titles & IDs
Public title
Evaluation of a Regional Healthy Skin Program in Remote Aboriginal Communities of Australia's Northern Territory
Scientific title
East Arnhem Healthy Skin Project: A Regional Collaboration to Reduce Scabies, Skin Sores and Associated Chronic Diseases, Including Rheumatic Fever and Renal Disease, Among Australian Aboriginal Communities
Secondary ID [1] 0 0
41 17May2004
Universal Trial Number (UTN)
Trial acronym
EAHSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scabies 0 0
Impetigo 0 0
Pyoderma 0 0
Streptococcal Infections 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Indigenous children aged <15 years - Indigenous children aged \<15 years within participating communities of the Northern Territory
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduced prevalence of scabies among children in the participating communities from 30% (expected prevalence pre-program) to <10% at least 2 years following the introduction of the program
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Reduced prevalence of skin sores among children in the participating communities from 50% (expected prevalence pre-program) to <25% at least 2 years following the introduction of the program
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Reduced severity of skin sores among children in the participating communities from 40% classified as moderate/severe (expected pre-program) to <15% classified as moderate/severe at least two years following the introduction of the program
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* All children aged <15 years in the participating communities
Minimum age
No limit
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
2329
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 0 0
Menzies School of Health Research - Casuarina
Recruitment postcode(s) [1] 0 0
0811 - Casuarina

Funding & Sponsors
Primary sponsor type
Other
Name
Menzies School of Health Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Melbourne
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Murdoch Childrens Research Institute
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Cooperative Research Centre for Aboriginal Health
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ross M Andrews, PhD
Address 0 0
Menzies School of Health Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00884728