Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001431819
Ethics application status
Approved
Date submitted
1/09/2021
Date registered
22/10/2021
Date last updated
18/10/2022
Date data sharing statement initially provided
22/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess the different options for collecting follow-up survey data, including electronic text messages, from people included in the Australian Stroke Clinical Registry.
Scientific title
Using Short Message Services (SMS) to Collect Patient Reported Outcomes for the Australian Stroke Clinical Registry (AuSCR): a comparative effectiveness project.
Secondary ID [1] 304862 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 322967 0
Transient ischaemic attack (TIA) 322968 0
Condition category
Condition code
Stroke 320542 320542 0 0
Ischaemic
Stroke 320543 320543 0 0
Haemorrhagic
Public Health 321243 321243 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible registrants from the Australian Stroke Clinical Registry (AuSCR) randomised to the intervention group will receive one SMS during the follow-up period (90-180 days post-admission for stroke or TIA). Approximately 90 days post-admission, all eligible registrants will be sent the follow-up questionnaire by mail. Where no response has been received, an SMS will be sent four weeks following the mail-out of the questionnaire.

The SMS will invite the registrant to complete a follow-up questionnaire by clicking on a unique link. The follow-up questionnaire is identical to that which is currently used by the registry in a paper format, distributed by mail, and that can be completed over the telephone. It includes questions on where the registrant is living, whether they are living alone, if they have had another stroke or been readmitted to hospital, a self-reported measure of disability (modified Rankin Scale [mRS]) and EuroQol EQ-5D-3L for health and quality of life indicators. The approximate time estimated for the completion of the questionnaire is ten minutes.

Successful delivery of the SMS will be monitored.

If no response is received to the SMS, the registrant will continue the standard AuSCR follow-up process. This includes a second mail-out of the questionnaire to the registrant/next of kin approximately two weeks following SMS (six weeks following first mail attempt). If no response received six weeks later, the registrant/next of kin will be called to see if they would like to complete the questionnaire over the phone.
Intervention code [1] 321248 0
Treatment: Other
Comparator / control treatment
Eligible registrants from the Australian Stroke Clinical Registry randomised to the control group will continue to receive follow-up as per the standard registry process. That is, at approximately 90 days following admission, a follow-up questionnaire is sent in the mail. If no response is received six weeks later, a second follow-up questionnaire is sent in the mail to the registrant and/or their proxy. If no response is received after another six weeks, the registrant and their listed emergency contact and alternative contact are phoned up to three times to ask if they would like to complete the questionnaire over the phone.
Control group
Active

Outcomes
Primary outcome [1] 328362 0
Proportion of eligible registrants who complete the follow-up questionnaire assessed by the records completed within the registry database
Timepoint [1] 328362 0
90-180 days after hospital admission
Secondary outcome [1] 398710 0
Median time to follow-up questionnaire completion calculated from the 'follow-up creation date' to the 'date follow-up response received' in the registry database
Timepoint [1] 398710 0
90-180 days after hospital admission
Secondary outcome [2] 398711 0
Proportions of missing data in the follow-up questionnaire assessed by audit of responses in the registry database
Timepoint [2] 398711 0
90-180 days after hospital admission
Secondary outcome [3] 398712 0
Cost of obtaining follow-up responses assessed by calculating the cost of the total number of text messages sent and follow-up via other methods (mail and telephone) based on responses recorded in the registry and registry financial records
Timepoint [3] 398712 0
90-180 days after hospital admission
Secondary outcome [4] 400251 0
Number of follow-up attempts assessed by audit of the registry database
Timepoint [4] 400251 0
90-180 days after hospital admission
Secondary outcome [5] 400252 0
Satisfaction with SMS option from a sub-set of registrants (n=50) who were randomised to the SMS group, completed follow-up, and indicated they are interested in participation in future research. This will be assessed by a 15 minute semi-structured interview using a study specific questionnaire.
Timepoint [5] 400252 0
within 1 month of completing a follow-up survey via SMS

Eligibility
Key inclusion criteria
All registrants known to be alive with an acute admission entered into the AuSCR for either stroke or TIA at a participating hospital with Human Research Ethics Committee approval to implement the SMS message as part of follow-up data collection. Registrants from metropolitan and regional hospitals in Victoria, Queensland, New South Wales, the Australian Capital Territory and Tasmania will be included.

For the process evaluation semi-structured interviews, only those registrants who have completed follow-up, were randomised to the SMS group and indicated they are interested in participation in future research will be contacted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Registrants with demographic data entered by hospitals into the registry >180 days post-admission.
Registrants known to be deceased, or have requested no follow-up, or opted out of the registry.
Registrants without a valid mobile phone number.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will occur using central randomisation by computer with a RedCAP database randomisation module.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A 1:1 block randomisation with minimum block sizes of 6 will be used. We will ensure balanced randomisation between males and females and age groups < 65 years and 65 years or over.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study is pragmatic and based upon our ability to complete registrant randomisation and the follow-up protocol within a six to twelve-month time frame using existing resources. We estimate we should be able to contact a minimum of 750 and a maximum of 1000 eligible AuSCR registrants for randomisation and follow-up within this timeframe. This would mean that we are able to detect at least a 7% difference between groups (based on the primary outcome) at a confidence level of 95% and a power of 80%.

For the primary analysis, data between the control and SMS/intervention group will be compared, with an intention to treat analysis.

Descriptive statistics will be used to describe the trial population at baseline and to examine within group and between group differences using methods appropriate for the distribution of the data. Where feasible, multivariable statistical models will be used with the outcome measures as the dependent variable, intervention groups as the independent variable and the baseline characteristics will serve as the covariates.

Descriptive statistics of the cohort choosing to complete follow-up electronically via SMS will be completed including both demographic (gender, age, state of residence, living arrangements), clinical characteristics (stroke type, stroke severity) and post-stroke outcomes (subsequent strokes/hospital readmissions, level of disability and health related quality of life). We will use statistical tests appropriate to the type and distribution of the variables.

Qualitative analysis
All interviews will be recorded, transcribed verbatim and participant-identifying information redacted prior to beginning the analysis.
Broad coding of themes and subthemes from review of the identified concepts in the transcribed text will be done and a coding tree developed. At least 10% of interviews will be dual-coded by a second researcher. Discrepancies in assignment of codes will be resolved and the coding tree adjusted if required, prior to completing all coding of transcripts. Systematic coding of the themes and subthemes will be undertaken moving from broader to narrower themes/sub-themes looking for similarities. Should new themes emerge, it will be compared with already identified codes in order to incorporate it into an existing theme or a new theme will be created.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
29/11/2021
Actual
15/02/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
5/07/2022
Date of last data collection
Anticipated
1/10/2023
Actual
Sample size
Target
750
Accrual to date
Final
1008
Recruitment in Australia
Recruitment state(s)
ACT,SA,TAS,VIC
Recruitment hospital [1] 20380 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 20382 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 20383 0
Royal Hobart Hospital - Hobart
Recruitment hospital [4] 20384 0
Launceston General Hospital - Launceston
Recruitment hospital [5] 20385 0
North West Regional Hospital - Burnie
Recruitment hospital [6] 20386 0
St John of God Hospital, Ballarat - Ballarat
Recruitment hospital [7] 20387 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [8] 20389 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [9] 20391 0
Wimmera Health Care Group - Horsham - Horsham
Recruitment hospital [10] 20393 0
Western District Health Service - Hamilton - Hamilton
Recruitment hospital [11] 20394 0
West Gippsland Healthcare Group - Warragul
Recruitment hospital [12] 20395 0
South West Healthcare - Warrnambool - Warrnambool
Recruitment hospital [13] 20398 0
Swan Districts Hospital - Middle Swan
Recruitment hospital [14] 20401 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [15] 20402 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [16] 20403 0
Frankston Hospital - Frankston
Recruitment hospital [17] 20405 0
Mildura Base Hospital - Mildura
Recruitment hospital [18] 20406 0
Maroondah Hospital - Ringwood East
Recruitment hospital [19] 20407 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [20] 20408 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment hospital [21] 20409 0
Echuca Regional Health - Echuca
Recruitment hospital [22] 20410 0
Central Gippsland Health Service (Sale) - Sale
Recruitment hospital [23] 20411 0
Box Hill Hospital - Box Hill
Recruitment hospital [24] 20412 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [25] 20413 0
Bass Coast Regional Health - Wonthaggi
Recruitment hospital [26] 20414 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment hospital [27] 20415 0
Bairnsdale Regional Health Service - Bairnsdale
Recruitment hospital [28] 20416 0
The Alfred - Melbourne
Recruitment hospital [29] 20419 0
The Canberra Hospital - Garran
Recruitment hospital [30] 20422 0
Calvary Private Hospital ACT - Bruce
Recruitment postcode(s) [1] 35142 0
5042 - Bedford Park
Recruitment postcode(s) [2] 35144 0
5000 - Adelaide
Recruitment postcode(s) [3] 35145 0
7000 - Hobart
Recruitment postcode(s) [4] 35146 0
7250 - Launceston
Recruitment postcode(s) [5] 35147 0
7320 - Burnie
Recruitment postcode(s) [6] 35148 0
3350 - Ballarat
Recruitment postcode(s) [7] 35149 0
3168 - Clayton
Recruitment postcode(s) [8] 35151 0
2617 - Bruce
Recruitment postcode(s) [9] 35153 0
3400 - Horsham
Recruitment postcode(s) [10] 35155 0
3300 - Hamilton
Recruitment postcode(s) [11] 35156 0
3820 - Warragul
Recruitment postcode(s) [12] 35157 0
3280 - Warrnambool
Recruitment postcode(s) [13] 35160 0
6056 - Middle Swan
Recruitment postcode(s) [14] 35164 0
3084 - Heidelberg
Recruitment postcode(s) [15] 35165 0
3199 - Frankston
Recruitment postcode(s) [16] 35167 0
3500 - Mildura
Recruitment postcode(s) [17] 35168 0
3135 - Ringwood East
Recruitment postcode(s) [18] 35169 0
3844 - Traralgon
Recruitment postcode(s) [19] 35170 0
3630 - Shepparton
Recruitment postcode(s) [20] 35171 0
3564 - Echuca
Recruitment postcode(s) [21] 35172 0
3850 - Sale
Recruitment postcode(s) [22] 35173 0
3128 - Box Hill
Recruitment postcode(s) [23] 35174 0
3550 - Bendigo
Recruitment postcode(s) [24] 35175 0
3995 - Wonthaggi
Recruitment postcode(s) [25] 35176 0
3220 - Geelong
Recruitment postcode(s) [26] 35177 0
3875 - Bairnsdale
Recruitment postcode(s) [27] 35178 0
3004 - Melbourne
Recruitment postcode(s) [28] 35180 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 309235 0
Other Collaborative groups
Name [1] 309235 0
Florey Institute of Neuroscience and Mental Health
Country [1] 309235 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy St
Heidelberg Vic 3084
Country
Australia
Secondary sponsor category [1] 310549 0
None
Name [1] 310549 0
Address [1] 310549 0
Country [1] 310549 0
Other collaborator category [1] 281962 0
University
Name [1] 281962 0
Monash University
Address [1] 281962 0
Wellington Rd, Clayton VIC 3800
Country [1] 281962 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309082 0
Austin Health HREC
Ethics committee address [1] 309082 0
Ethics committee country [1] 309082 0
Australia
Date submitted for ethics approval [1] 309082 0
24/10/2019
Approval date [1] 309082 0
19/11/2019
Ethics approval number [1] 309082 0

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

Contacts
Principal investigator
Name 112914 0
Prof Dominique Cadilhac
Address 112914 0
The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg Victoria 3084
Country 112914 0
Australia
Phone 112914 0
+61 3 9035 7032
Fax 112914 0
Email 112914 0
[email protected]
Contact person for public queries
Name 112915 0
Dominique Cadilhac
Address 112915 0
The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg Victoria 3084
Country 112915 0
Australia
Phone 112915 0
+61 3 9035 7032
Fax 112915 0
Email 112915 0
[email protected]
Contact person for scientific queries
Name 112916 0
Dominique Cadilhac
Address 112916 0
The Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg Victoria 3084
Country 112916 0
Australia
Phone 112916 0
+61 3 9035 7032
Fax 112916 0
Email 112916 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised data collected for the process evaluation can be made available upon reasonable request.
Anonymised patient-level data can be requested from the Australian Stroke Clinical Registry for secondary purposes by qualified researchers according to the approved data access policies see www.auscr.com.au.
When will data be available (start and end dates)?
Available 2 years from publication of the study, no end date.
Available to whom?
qualified researchers
Available for what types of analyses?
secondary analyses that do not replicate the analyses presented in publications
meta-analysis
How or where can data be obtained?
contact the corresponding author via email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12777Study protocolCadilhac DA, Morrison J, Breen S, Kilkenny MF, Lannin NA, Lester M, Barclay-Moss K, Grimley R and Middleton S. Using Short Message Services (SMS) to Collect Patient Reported Outcomes for the Australian Stroke Clinical Registry (AuSCR): Comparative Effectiveness Project. Protocol Version 2, July 2021.  [email protected] Will be provided on reasonable request
12778Ethical approval  [email protected] 382464-(Uploaded-26-08-2021-17-20-04)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
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.