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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.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
ACTRN12610000337077
Ethics application status
Approved
Date submitted
25/04/2010
Date registered
28/04/2010
Date last updated
13/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing telephone versus mail survey methods with stroke survivors, on response rate, time to response, and completeness.
Scientific title
A randomised trial with stroke survivors to compare telephone to mail survey methods on response rate, time to response and completeness of survey responses.
Secondary ID [1] 251655 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Survey Response Rate 257242 0
Stroke 257256 0
Condition category
Condition code
Other 257382 257382 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Stroke 257394 257394 0 0
Ischaemic
Stroke 257395 257395 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Survey administered by mail. Survey includes questions about readmission, subsequent strokes, and the EQ5D (used to measure the health-related quality of life dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The survey takes approximately 10 minutes to complete. The Survey is sent with a Reply Paid Envelope; survey must be returned within 2 weeks of receiving it. If not received after this, the survey is re-delivered (maximum of 3 surveys mailed).
Intervention code [1] 256361 0
Other interventions
Comparator / control treatment
Survey administered by telephone. Survey includes questions about readmission, subsequent strokes, and the EQ5D (used to measure the health-related quality of life dimensions of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). The survey is administered by a health professional, and it takes approximately 10 minutes to complete. Only one survey is administered; three telephone calls to obtain a response are made prior to counting the participant as incomplete.
Control group
Active

Outcomes
Primary outcome [1] 258291 0
Response rate: a response is defined as completion of mandatory questions, specifically readmission (yes/no), subsequent stroke (yes/no).
Timepoint [1] 258291 0
Three months after admission to hospital.
Secondary outcome [1] 263989 0
Time to response: length of time between contact (by mail or telephone) to obtaining a response.
Timepoint [1] 263989 0
time to response assessed from time of contact for followup (at 3 months post-admission) for a period of up to 12 weeks.

Eligibility
Key inclusion criteria
Registered case in the Australian Stroke Clinical Registry
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Computer generated and allocated online sysetm; allocation is therefore concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated within the Registry database
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
30/09/2012
Sample size
Target
300
Accrual to date
Final
559
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 256863 0
Commercial sector/Industry
Name [1] 256863 0
Allergan Australia
Country [1] 256863 0
Australia
Funding source category [2] 256864 0
Other Collaborative groups
Name [2] 256864 0
Stroke Society of Australasia
Country [2] 256864 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian Stroke Clinical Registry Management Committee
Address
PO Box M201, Missenden Road, Sydney NSW 2050
Country
Australia
Secondary sponsor category [1] 256139 0
None
Name [1] 256139 0
Address [1] 256139 0
Country [1] 256139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258888 0
NSW Population and Health Services Research Ethics Committee
Ethics committee address [1] 258888 0
Cancer Institute NSW
PO Box 41, Alexandria, NSW 1435
Ethics committee country [1] 258888 0
Australia
Date submitted for ethics approval [1] 258888 0
Approval date [1] 258888 0
01/06/2009
Ethics approval number [1] 258888 0

Summary
Brief summary
A prospective randomized trial of the method of follow-up: cases registered in a national registry who were 3-months post-stroke receive the survey by mail or telephone. Data included collection of stroke and re-hospitalisation rates, and health-related quality of life. Response rates, time to response, and completeness of data were compared. Factors potentially associated with the outcome were explored.
Trial website
Trial related presentations / publications
Lannin NA, Anderson C, Lim J, Paice K, Price C, Faux S, Levi C, Donnan G, Cadilhac D. Telephone follow-up was more expensive but more efficient than postal in a national stroke registry. J Clin Epidemiol. 2013 Aug;66(8):896-902. doi: 10.1016/j.jclinepi.2013.03.005.
Public notes

Contacts
Principal investigator
Name 31094 0
A/Prof Natasha Lannin
Address 31094 0
Occupational Therapy Department
The Alfred
Prahran
Victoria 3181
Country 31094 0
Australia
Phone 31094 0
+61 4 17135153
Fax 31094 0
Email 31094 0
N.Lannin@latrobe.edu.au
Contact person for public queries
Name 14341 0
Natasha Lannin
Address 14341 0
Occupational Therapy Department
The Alfred
Prahran
Victoria 3181
Country 14341 0
Australia
Phone 14341 0
+61 3 94796745
Fax 14341 0
Email 14341 0
n.lannin@latrobe.edu.au
Contact person for scientific queries
Name 5269 0
Natasha Lannin
Address 5269 0
Occupational Therapy Department
The Alfred
Prahran
Victoria 3181
Country 5269 0
Australia
Phone 5269 0
+61 3 94796745
Fax 5269 0
Email 5269 0
n.lannin@latrobe.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
SourceTitleYear of PublicationDOI
EmbaseRealising the potential: leveraging clinical quality registries for real world clinical research.2022https://dx.doi.org/10.5694/mja2.51443
Dimensions AIResearch Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry2024https://doi.org/10.1016/j.jphys.2024.02.015
N.B. These documents automatically identified may not have been verified by the study sponsor.