Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000020684
Ethics application status
Approved
Date submitted
14/07/2005
Date registered
18/07/2005
Date last updated
16/01/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Text-messages to communicate with young people involved in primary care research: a randomised controlled trial
Scientific title
Text-messages to communicate with young people involved in primary care research: a randomised controlled trial to determine response rate using this method
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
No specific condition is being studied. The trial applies to any young people consulting in primary care. 82 0
Condition category
Condition code
Other 102 102 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of text-messaging to obtain additional research data from patients following the consultation.
Intervention code [1] 22 0
Other interventions
Comparator / control treatment
The control condition is use of traditional card reponse method to obtain the same information.
Control group
Active

Outcomes
Primary outcome [1] 128 0
Response rate to a question on satisfaction following the consultation
Timepoint [1] 128 0
Following the consultation
Secondary outcome [1] 291 0
Content of the response
Timepoint [1] 291 0
following the consultation

Eligibility
Key inclusion criteria
Patients attending randomly selected general practices in Victoria
Minimum age
16 Years
Maximum age
24 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any condition that might impair on the ability to consent: acute medical condition requiring immediate attention by GP, known schizophrenia or chronic psychosis, organic mental disorder, mental disability, presence of severe language or hearing disability, insufficient understanding of English for interview without a translator). In addition, patients who do not have a mobile phone will be excluded.

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)
Allocation to intervention or control was by days of recruitment. Thus concealment was no longer possible after the first patient of the day was included
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence of allocation per day, stratified for practices, was generated by a statistician independant to the study, using the STATA software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 196 0
3000

Funding & Sponsors
Funding source category [1] 136 0
University
Name [1] 136 0
Swiss fellowship grant
Country [1] 136 0
Switzerland
Funding source category [2] 137 0
University
Name [2] 137 0
The University of Melbourne
Country [2] 137 0
Australia
Primary sponsor type
Other
Name
Centre for Adolescent Health, Murdoch Children's Institute
Address
2, Gatehouse street
3052, Parkville, Victoria
Country
Australia
Secondary sponsor category [1] 98 0
None
Name [1] 98 0
none
Address [1] 98 0
none
Country [1] 98 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36322 0
Address 36322 0
Country 36322 0
Phone 36322 0
Fax 36322 0
Email 36322 0
Contact person for public queries
Name 9211 0
Dagmar Haller
Address 9211 0
Department of community and primary care medicine, Geneva University Hospitals,
24 rue Micheli-du-Crest, 1211 Geneva
Country 9211 0
Switzerland
Phone 9211 0
+41 22 372 96 79
Fax 9211 0
+41 22 372 96 00
Email 9211 0
[email protected]
Contact person for scientific queries
Name 139 0
Dagmar Haller
Address 139 0
Department of community and primary care medicine, Geneva University Hospitals,
24 rue Micheli-du-Crest, 1211 Geneva
Country 139 0
Switzerland
Phone 139 0
+41 22 372 96 79
Fax 139 0
+41 22 372 96 00
Email 139 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.