ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Survey Response Rate

Stroke

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Stroke

Ischaemic

Stroke

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]

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]

Response rate: a response is defined as completion of mandatory questions, specifically readmission (yes/no), subsequent stroke (yes/no).

Timepoint [1]

Three months after admission to hospital.

Secondary outcome [1]

Time to response: length of time between contact (by mail or telephone) to obtaining a response.

Timepoint [1]

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?

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]

Commercial sector/Industry

Name [1]

Allergan Australia

Address [1]

Level 4
810 Pacific Highway
Gordon, NSW 2072

Country [1]

Australia

Funding source category [2]

Other Collaborative groups

Name [2]

Stroke Society of Australasia

Address [2]

Level 3, 33-35 Atchison Street, St Leonards NSW 2065

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

NSW Population and Health Services Research Ethics Committee

Ethics committee address [1]

Cancer Institute NSW
PO Box 41, Alexandria, NSW 1435

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/06/2009

Ethics approval number [1]

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

A/Prof Natasha Lannin

Address

Occupational Therapy Department
The Alfred
Prahran
Victoria 3181

Country

Australia

Phone

+61 4 17135153

Fax

N.Lannin@latrobe.edu.au

Contact person for public queries

Name

Natasha Lannin

Address

Occupational Therapy Department
The Alfred
Prahran
Victoria 3181

Country

Australia

Phone

+61 3 94796745

Fax

n.lannin@latrobe.edu.au

Contact person for scientific queries

Name

Natasha Lannin

Address

Occupational Therapy Department
The Alfred
Prahran
Victoria 3181

Country

Australia

Phone

+61 3 94796745

Fax

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

Source	Title	Year of Publication	DOI
Embase	Realising the potential: leveraging clinical quality registries for real world clinical research.	2022	https://dx.doi.org/10.5694/mja2.51443
Dimensions AI	Research Note: Registry-based randomised controlled trials with examples from the Australian Stroke Clinical Registry	2024	https://doi.org/10.1016/j.jphys.2024.02.015

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically