ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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

ACTRN12622001015730

Ethics application status

Approved

Date submitted

10/06/2022

Date registered

20/07/2022

Date last updated

3/04/2024

Date data sharing statement initially provided

20/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Australian Stroke Clinical Registry - LIfe after Stroke Tailored Support (A-LISTS) study

Scientific title

Australian Stroke Clinical Registry - LIfe after Stroke Tailored Support (A-LISTS) study:
mixed methods study with a pilot randomised controlled trial for people living with stroke

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1276-1898

Trial acronym

A-LISTS

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Pre-hospital component (all participants before randomisation): Baseline assessments are completed by trained data collectors for the Australian Stroke Clinical Registry (AuSCR) by phone. For the baseline assessment, consented participants are asked questions about their current health conditions and residence, quality of life (EuroQoL-5-3L dimension, EQ-5D), disability (modified Rankin Scale, mRS) and complete the longer-term unmet needs (LUNS) questionnaire. This interview will take approximately 30 minutes to complete. All participants are informed that a stroke service coordinator from the hospital that they were discharged from that participates in AuSCR may contact them via phone.

Randomisation: For those allocated to the intervention group, an electronic report about the participants health and unmet needs status is generated (A-LISTS patient report), and then securely forwarded electronically to the participating hospital's nominated service coordinator. The report includes a summary of the baseline measurements ascertained by the AuSCR team member for the participant.

Hospital component (post randomisation): The nominated stroke service coordinator will receive an ~4 hour training program via videoconference with relevant project team members and with online modules with self-assessments prior to commencement of the trial. The stroke service coordinator will contact the participant via telephone to ask them questions about their health status and unmet needs, clarifying with them about current management and also their past medical history related to their baseline responses. They will seek to understand the potential contributing factors for the responses. The stroke service coordinator will determine which healthcare providers are currently managing their care and if they need further support from the hospital or a broader range of healthcare providers. They will determine if the participant's General Practitioner (GP) should be contacted/involved and ask permission to forward the A-LISTS patient report. The stroke service coordinator will then outline what additional support or case management might be offered and seeks approval to set up consultations, as required. This consultation may take up to 60-90 minutes. The outcomes of this assessment are documented in the participant's medical file and the relevant data entered into the electronic case report form (eCRF).

One of three options then occurs. Option 1 is if no further action is required by the hospital, the service coordinator will send the A-LISTS patient report to the nominated GP, if the participant consents to this, with a cover letter outlining the initial review and its outcomes and any further steps discussed with the patient. Option 2 is if further action is required by the hospital, the service coordinator can then arrange telehealth or in person consultations with relevant members of the interdisciplinary team and/ GP or other health care providers in the community as advised by the patient. Additionally, referrals and any additional appointments with the stroke team can be scheduled, as required. Option 3 is if the participant is uncontactable or refuses to engage with the hospital. A cover letter and a copy of the A-LISTS patient report will be sent to the GP with the patient's permission. If uncontactable, or permission is not granted then details will be documented in the medical record. All relevant data will be entered into the eCRF.
The criteria for determining whether the participant falls into option 1 or 2 is dependent on the stroke service coordinators judgement. If the coordinator identifies suitable follow-up services and the participant agrees, then a referral will be made. If the participant reports that they feel they do not need a follow-up service then no referral will be made.

During the 12 week intervention period, participants are asked to complete a paper diary by writing down any time they have contact with a healthcare or community services provider, including medical specialist visits or attend an allied health therapy session (such as a physiotherapist, etc). The stroke service coordinator has a maximum of 4 hours per week for 12 weeks to make follow-up calls. Subsequent calls to participants may be via telephone, face-to-face or video-conference depending on the participants preference.

End week 12: A follow-up survey repeating the baseline assessments is conducted over the phone around week 12-14 post randomisation whereby a blinded research assistant from the AuSCR office collects the follow-up data. This will take approximately 30 minutes to complete. Participants will be asked questions about their current residence, quality of life (EQ-5D), disability (mRS), longer-term unmet needs (LUNS), the number of unplanned hospital visits since discharge and the number of current health or community services used, new medication use and any costs incurred since randomisation.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Participants in the control group will receive their usual care in the community. Usual care may involve the participant contacting their GP or other health care providers of their own accord if they have concerns regarding an unmet need. To avoid unblinding to group allocation, the control group will not be informed about the type of intervention being tested but will be told that the method by which we communicate with them, and the amount of communication will differ based on the group they have been allocated. To support engagement (and to mask the true nature of the intervention), following randomisation, and consistent with the intervention group, they will be provided a paper diary to record healthcare and community services contacts and referrals including the date and reason for the visit, and asked to complete the follow-up survey to be conducted within 12-14 weeks following randomisation. The follow-up survey repeating the baseline assessments is conducted over the phone around week 12-14 post randomisation whereby a blinded research assistant from the AuSCR office collects the follow-up data. This interview will take approximately 30 minutes to complete.
The clinicians from the hospitals will not be directly informed of these participants that have met inclusion criteria for the follow-up service until after the trial is completed. This is to avoid cross-overs. At the end of the trial, should control participants have ongoing high levels of unmet needs, this information will be passed onto the hospital team and they can choose to offer the Stroke Follow-up Service within their own resources to these participants or, if the patient consents, a copy of their A-LISTS patient report that can be generated from their follow-up survey will be posted or emailed to their local GP.

Control group

Active

Outcomes

Primary outcome [1]

The proportion of participants that completed the feasibility trial assessed by auditing the study database

Timepoint [1]

12-14 weeks post randomisation

Primary outcome [2]

The proportion of intervention participants that attended the follow-up service assessed by auditing the study database

Timepoint [2]

12-14 weeks post randomisation

Primary outcome [3]

The proportion of participants (patients) satisfied with the follow-up service assessed through a survey and/or interview/focus group with questions designed specifically for this study

Timepoint [3]

12-14 weeks post randomisation

Secondary outcome [1]

Proportion of unplanned presentations to emergency departments or admission (composite) to hospital assessed by a survey with questions designed specifically for this study

Timepoint [1]

12-14 weeks post randomisation

Secondary outcome [2]

Proportion of participants with extreme health problems (as defined by the criteria for reaching the threshold for referral to the follow-up service (composite outcome): defined as i) an extreme problem in any EQ-5D dimension; or ii) an overall HR-QoL score on the Visual Analogue Scale (VAS) below 60.

Timepoint [2]

12-14 weeks post randomisation

Secondary outcome [3]

Proportion of participants reporting extreme problems in any domain of the 5 domains of the EQ5D-3L

Timepoint [3]

12-14 weeks post randomisation

Secondary outcome [4]

Proportion of participants reporting an overall HR QoL Visual Analogue Scale score (Eq5D) of 60 or less.

Timepoint [4]

12-14 weeks post randomisation

Secondary outcome [5]

Proportion of participants with a change in their global disability assessed using the modified Rankin scale

Timepoint [5]

12-14 weeks post randomisation

Secondary outcome [6]

Costs assessed using a cost consequences analysis
Unit prices for resources used and productivity will be obtained from the most contemporary Australian sources.

Timepoint [6]

12-14 weeks post randomisation

Secondary outcome [7]

The proportion of participants (clinicians) satisfied with the follow-up service assessed through a survey and/or interview/focus group

Timepoint [7]

12-14 weeks post randomisation

Secondary outcome [8]

Proportion of health services used* assessed by a survey with questions designed specifically for this study

*Participants health diary used as a memory aid to respond to this outcome

Timepoint [8]

12-14 weeks post randomisation

Secondary outcome [9]

Proportion of medications used assessed by a survey with questions designed specifically for this study

Timepoint [9]

12-14 weeks post randomisation

Secondary outcome [10]

Median/mean number of unmet needs (measured using Long-Term Unmet Needs (LUNS) survey - 22 items).

Timepoint [10]

Secondary outcome [11]

Median/mean number of unmet needs (measured using Long-Term Unmet Needs (LUNS) survey - 22 items).

Timepoint [11]

12-14 weeks post randomisation

Eligibility

Key inclusion criteria

Must meet the agreed criteria for ‘high levels of unmet health needs’ provisionally defined as an extreme problem in any EQ5D domain, or have an overall quality of life score of below 60 (Visual Analogue Scale, EQ5D) self-report on the Australian Stroke Clinical Registry follow-up survey conducted between 90-180 days after stroke and will:
i) have indicated a willingness to be contacted for further research on the Australian Stroke Clinical Registry follow-up survey conducted between 90-180 days after stroke;
ii) be aged 18 years and above;
iii) have a confirmed acute stroke;
iv) be living in the community in a private residence, (i.e., not hospital or high care residential aged care facility or other institution);
v) able to participate in English and provide informed consent via a self-report or appropriate proxy to assist.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

i) Australian Stroke Clinical Registry registrants with a transient ischemic stroke (TIA) will be excluded as they are often managed in outpatient stroke services and should not have any residual impairments as the condition is not permanent
ii) Have a life threating illnesses and are unlikely to survive to the study endpoint (i.e. 12-14 weeks post randomisation).

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)

Central randomisation by phone/fax/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation occurs using the online system through REDCap (1:1 ratio), stratified by age (<65 or 65+ years) and sex (male, female).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

The A-LISTS study has two stages: i) an intervention co-design stage with clinicians, academics and people with lived experience of stroke (not registered separately); and ii) a randomised controlled pilot trial to test the feasibility of providing the follow-up service intervention.
The two stages have not been registered separately.
Other design features:
Qualitative (interviews/focus group) and a process evaluation that includes acceptability and feasibility feedback and assessment of intervention fidelity assessed throughout the trial at the research-team level and the practitioner-patient level.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive statistics will be used to describe the trial population at baseline. Within group changes will be examined using McNemar’s test and between group differences will be examined using parametric or non-parametric methods appropriate to the distribution of the data. Where feasible, multivariable statistical models will also be used to adjust for baseline differences between the intervention and control groups for baseline variables with a p-value of <0.2.
Primary analyses will be based on intention-to-treat principles. Statistical significance determined at p < 0.05. Per program analyses and sensitivity analyses will also be performed.

Due to the skewed distribution of continuous outcomes, between-group differences will be reported as median difference (95% CI). Reporting of patient (e.g., type of unmet need) and hospital (e.g., metro/rural location) will be described as part of the analysis and presentation of results. We will describe the difference in the proportion of patients in each group that remain in the ‘high levels of unmet needs’ group at 90-days post randomisation. We will also explore differences in HRQoL and Unmet needs (LUNS questionnaire) in terms of change scores.
The modified Rankin (mRS) change will be assessed as a shift analysis. The Cochran-Mantel-Haenszel shift test will be used to analyse the distribution of the 90-day mRS outcomes in the intervention and control groups. The results will also be compared using a dichotomized mRS outcome by logistic regression (0 to 2 vs 3, or 0 to 1 vs 3)
For the cost consequences analysis, resource use items will be valued using the most appropriate price to convert these into costs. HRQoL data from the EQ5D-3L will be converted to a utility score. The reported clinically meaningful difference in the EQ-5D utility scores ranges from 8 and 12 points in considering whether an intervention is worthwhile for stroke.

Between group differences in EQ-5D utility scores and the Visual Analogue Scale responses, and the differences in the proportion of participants with a clinically meaningful change in these scores will be assessed. We will also describe changes to problems reported in each of the EQ-5D dimensions (mobility, self-care usual activities, pain, anxiety and depression) by group.

Where appropriate, multivariable statistical models will also be used to adjust for baseline differences between comparator groups where outcome data are being assessed. Treatment of missing data will be based on the satisfiability of missingness at random assumptions. Statistical significance will be determined at p<0.05. Sensitivity analyses may also be performed, if appropriate.

Treatment of missing data will be based on the satisfiability of ‘missingness at random’ assumptions.

Feasibility data will be analysed descriptively including participants attending consultations for which there was a referral, and missing data on surveys.
Intervention fidelity data including completion of the follow-up service training, or intervention forms and the project issues register will also be summarised.
Cost consequence analysis to explore costs from a societal and health sector perspective.
Focus group and open text responses from the satisfaction surveys will be analysed using inductive and deductive thematic analyses as appropriate with coding of a proportion of records checked by two researchers.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

4/04/2023

Actual

4/04/2023

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,TAS,VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [3]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [4]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [5]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [6]

Royal Hobart Hospital - Hobart

Recruitment hospital [7]

Barwon Health - Geelong Hospital campus - Geelong

Recruitment hospital [8]

Redcliffe Hospital - Redcliffe

Recruitment hospital [9]

Rockhampton Base Hospital - Rockhampton

Recruitment hospital [10]

Princess Alexandra Hospital - Woolloongabba

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

4575 - Birtinya

Recruitment postcode(s) [3]

5000 - Adelaide

Recruitment postcode(s) [4]

3050 - Parkville

Recruitment postcode(s) [5]

3168 - Clayton

Recruitment postcode(s) [6]

7000 - Hobart

Recruitment postcode(s) [7]

3220 - Geelong

Recruitment postcode(s) [8]

4020 - Redcliffe

Recruitment postcode(s) [9]

4700 - Rockhampton

Recruitment postcode(s) [10]

4102 - Woolloongabba

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (2020 Cardiovascular Health Mission, #2008668)

Address [1]

16 MARCUS CLARKE STREET, Canberra Australian Capital Territory 2601

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Florey Institute of Neuroscience and Mental Health

Address

245 Burgundy Street, Heidelberg, VIC, 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Research Ethics Department

Ethics committee address [1]

L8 Harold Stokes Building, 
145 Studley Road, Heidelberg
PO Box 5555, Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/03/2022

Approval date [1]

29/11/2022

Ethics approval number [1]

HREC/89487/Austin-2022

Ethics committee name [2]

Monash University

Ethics committee address [2]

Wellington Road
Clayton
Victoria
3800

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/06/2022

Approval date [2]

07/02/2023

Ethics approval number [2]

Project Number: 36820

Summary

Brief summary

After a new stroke, the presence of physical disability, loss of employment, inability to participate in pre-stroke activities, social isolation, anxiety and depression make returning to the community difficult. Many people living with stroke have ongoing disability and report extreme problems in their quality of life.  The purpose of this project is to develop and evaluate the feasibility of providing a co-designed, hospital-initiated follow-up service to support people living with stroke. This service is designed to prioritise support to people who are registered in the Australian Stroke Clinical Registry and report unmet needs and extreme health problems on a patient-reported outcomes survey collected between 90-180 days of discharge from hospital after a new stroke. 

Following the design and an initial non-randomised piloting of the intervention components (not registered separately) in up to 5 patients at one hospital to enable refinements to the clinical tools and protocol, we seek to complete a multicentre, randomised controlled pilot trial. In up to 6 hospitals and with approximately 100 eligible patients randomised to either usual care or the intervention we will test the feasibility and acceptability of this proposed follow-up service. Our study includes a process evaluation and cost consequences analysis to inform future scaling of the intervention including providing an understanding of the costs to provide the service in terms of the type of patient benefits may be achieved. The outcomes of this study may also be used to inform undertaking a fully powered effectiveness study.

We seek to proactively use registry data to provide more tailored support for survivors of stroke who have reported extreme unmet needs and direct them to relevant services.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Dominique Cadilhac

Address

Public Health and Health Services Research Group — Stroke

The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 9035 7032

Fax

[email protected]

Contact person for public queries

Name

Andrew Ross

Address

The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 9035 7067

Fax

[email protected]

Contact person for scientific queries

Name

Dominique Cadilhac

Address

Public Health and Health Services Research Group — Stroke

The Florey Institute of Neuroscience and Mental Health

245 Burgundy Street, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 9035 7032

Fax

[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?

On completion of publications by the investigators and A-LISTS collaborators, anonymised data will be available for secondary research purposes such as pooling data for meta analysis of similar studies, or complimentary research questions.
Data from the Australian Stroke Clinical Registry used in this study cannot be shared. Qualified investigators may apply to access those data separately.

When will data be available (start and end dates)?

Anticipated from 2024, no end date determined.

Available to whom?

Academics and students

Available for what types of analyses?

Research questions that do not replicate our primary and secondary outcome analyses

How or where can data be obtained?

Direct contact with the Coordinating Principal Investigator, Professor Dominique Cadilhac by email [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
15458	Study protocol	[email protected]
15460	Informed consent form	[email protected]
15522	Clinical study report	[email protected]
15523	Ethical approval	[email protected]

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
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

Documents added manually

Documents added automatically