Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000593831
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
18/05/2021
Date last updated
19/04/2022
Date data sharing statement initially provided
18/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
TeleClinical Care - STROKE: A randomised controlled trial of a smartphone application of care in stroke patients.
Scientific title
TeleClinical Care - STROKE: A randomised controlled trial of the effect of a comprehensive smartphone application-centric model of care on rates of re-hospitalisation in stroke patients.
Secondary ID [1] 303584 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 320953 0
hypertension 321457 0
Condition category
Condition code
Stroke 318761 318761 0 0
Ischaemic
Stroke 318762 318762 0 0
Haemorrhagic
Cardiovascular 318763 318763 0 0
Hypertension
Physical Medicine / Rehabilitation 318764 318764 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The total duration of the intervention will be 6 months. The intervention group will receive the TCC-STROKE smartphone application and Bluetooth-enabled peripheral devices. Patients will be trained by delegated study staff (stroke nurse practitioner, neurologist, physiotherapist, or study coordinator) in their use prior to discharge. The wearable device automatically sends activity on a daily basis. Patients will be asked, via automated text reminder, to manually measure their BP once a day using a brachial BP device. At the same time, patients will be asked to record their ECG on a portable ECG device. All manual BP and ECG data will automatically be uploaded to the app via Bluetooth. Patients will have access to their own data via the app, including activity, BP and HR. They will also receive daily text reminders of their activity goals and medication alerts via the app. Activity goals are generic reminders. Medication alerts are personalized: a Medication Compliance Monitor (MCM) will be used and the patient's medications list will be set based on their discharge medication plan. Medication compliance will be remotely monitored, and based on the MCM, non-adherence alerts will be sent to patients, or their carer, and the TCC-Stroke team.

Also, Intervention group participants will receive a self-managed StandingTall rehabilitation program, including strength, balance, and cognitive dual-task training. As part of the TCC-Stroke system, the total duration of StandingTall rehabilitation program is also 6 months and it will be undertaken concurrently with the TCC-Stroke intervention. The study participant will have a set-up session with an exercise specialist or delegated study staff before discharge. During the set-up session, the study staff will install the app on participant’s device, complete the initial balance assessment with the participant and make modifications to exercises. With StandingTall, the participant can decide when to exercise and choose the session duration. The weekly exercise recommendations will start at 40 minutes, a level that is easy to manage. Each fortnight, the amount of exercise increases by 20 minutes. The aim is to gradually build up the sessions to accumulate a total of 120 minutes per week. The StandingTall program includes a variety of balance exercises (such as stand on one leg, standing with eyes closed, or leaning forwards and backwards) tailored to participant’s ability. The StandingTall app needs to be connected to the internet for the purposes of the study as it will update the study team with participant’s progress and adherence.
Intervention code [1] 319875 0
Treatment: Other
Intervention code [2] 320192 0
Prevention
Intervention code [3] 320193 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive usual medical care from their treating physicians. All assessments at day 90 and 180 will be identical to those in the intervention group.

Usual medical care will follow the Clinical Guidelines for Stroke Management published by Stroke Foundation Australia.
Control group
Active

Outcomes
Primary outcome [1] 326711 0
The rate of re-hospitalisation within 90 days of randomisation. Events will be ascertained with in person/telehealth consultations and hospital chart reviews.
Timepoint [1] 326711 0
90 days after the day of randomization.
Primary outcome [2] 326712 0
The rate of re-hospitalisation within six months of randomisation. Events will be ascertained with in person/telehealth consultations and hospital chart reviews.
Timepoint [2] 326712 0
180 days after the day of randomisation.
Secondary outcome [1] 392446 0
Cost-effectiveness of this intervention.

An economic evaluation from the health system and societal perspective will be conducted alongside the Randomized Controlled Trial to determine whether TCC-Stroke represents value for money as an intervention to improve patient outcomes post stroke. Costs associated with the intervention (management and upkeep of TCC-Stroke app and KIOLA database, peripheral devices, salary of physiotherapist/occupational therapist administering the intervention) will be collected using trial records and average salary rates as per NSW Health. Healthcare utilisation (hospitalisation, medical tests/examinations and pharmaceuticals) and personal costs (e.g. time off work, presenteeism cost, travel time for attending medical appointments, and out-of-pocket medical expenses) will be assessed using a resource use questionnaire at three and six months consistent with the duration of the trial. Healthcare utilisation will be matched to appropriate costs published by the Independent Hospital Pricing Authority, Medical Benefits Schedule and Pharmaceutical Benefits Scheme. The validated EQ-5D-5L, measured at baseline, three and six months, will be used to estimate Quality-adjusted life years (QALYs) to enable the reporting of cost per QALY, a metric which facilitates comparison with other health interventions. A generalised linear model will be used to estimate both costs and outcomes over a three and six-month period. Bootstrapping will be conducted to present uncertainty around the incremental cost-effectiveness ratio, presented in the form of cost-effectiveness planes and acceptability curves.
Timepoint [1] 392446 0
180 days after the day of randomization.
Secondary outcome [2] 392447 0
Proportion of patients with BP target achieved assessed using a sphygmomanometer.

BP target:
Systolic BP < 140mmHg
Systolic BP < 130mmHg in diabetic patients.
Timepoint [2] 392447 0
90 days and 180 days after the day of randomisation
Secondary outcome [3] 392448 0
The proportion of patients compliant with medication will be assessed by analysis of app-recorded data for participants in the intervention group and by analysis of the Morisky Medication Adherence Score (MMAS-8) scores in the control group.
Timepoint [3] 392448 0
90 days and 180 days after the day of randomisation.
Secondary outcome [4] 392449 0
The proportion of patients with a diagnosis of new AF post-discharge will be assessed by analysis of app-recorded ECG data for participants in the intervention group and by accessing patient medical records for ECG studies ordered by the treating team in the control group.
Timepoint [4] 392449 0
90 days and 180 days after the day of randomisation.
Secondary outcome [5] 392450 0
Quality of Life Score (EuroQol EQ5D-5L will be used)
Timepoint [5] 392450 0
180 days after the day of randomisation.
Secondary outcome [6] 392451 0
Change in the functional outcome—modified Rankin Scale
Timepoint [6] 392451 0
90 days and 180 days after the day of randomisation.
Secondary outcome [7] 392452 0
Static balance and fall risk assessed using the Berg Balance Score
Timepoint [7] 392452 0
90 days and 180 days after the day of randomisation.
Secondary outcome [8] 392453 0
The number of Emergency Department visits between randomisation and day 90. Also, To The number of Emergency Department visits will be assessed by assessing patient medical records, also, patients will be asked if they had any Emergency Department visit after discharge from the hospital at day 90 follow-up.
Timepoint [8] 392453 0
90 days after the day of randomisation.
Secondary outcome [9] 392454 0
The number of adverse events compared between study groups.
Adverse events will be assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5).
Timepoint [9] 392454 0
90 days and 180 days after the day of randomisation.
Secondary outcome [10] 394326 0
Number of falls between randomisation and day 90, and number of falls between randomisation and day 180. Study participants will be asked to record their falls in a falls diary.
Timepoint [10] 394326 0
90 days and 180 days after the day of randomisation.

Eligibility
Key inclusion criteria
• Male or female patients >18 years of age.
• Ischaemic stroke/Transient Ischaemic Attack or Primary Intracerebral Haemorrhage (Anticoagulant-Associated Haemorrhage patients are eligible) diagnosed clinically by stroke specialist, with consistent neuro-imaging results and admitted to hospital for diagnosis/treatment.
• Patient (or carer) owns a compatible smartphone and can use the app, wearables and peripherals.
• Enrolment can be performed at the time of discharge from acute care. Patients may be enrolled after a period of inpatient rehabilitation, only if performed at the same centre where acute care was delivered.
• Informed consent obtained from either the patient or substitute decision maker prior to any study related procedures being performed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients diagnosed with stroke mimics – such as seizures, migraine, etc.
• Patients with Intracerebral Hemorrhage (ICH) secondary to arteriovenous malformations, intracranial aneurysms, tumours or abscesses. Note: Individuals with small incidental lesions, i.e. a benign lesion such as a small meningioma, are eligible.
• Patients who will not be able to use StandingTall program (such as people who are wheelchair bound, having a physical condition that prevents exercise at home, or not feasible of using StandingTall judged by the rehabilitation team)
• Co-morbid illness with expected life expectancy of <6 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomisation design will be used, as well as stratification by enrolling site, stroke type (Ischaemic/ICH), age (>/< 65 years) and gender.
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 primary outcome (all cause hospital admission within 6 months of randomisation) will be assessed as a difference of proportions. The primary analysis will be performed on an intention-to-treat basis. No interim analyses are planned. Secondary endpoint analyses will be undertaken using appropriate regression models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
1/11/2021
Date of last participant enrolment
Anticipated
1/01/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
700
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307985 0
Government body
Name [1] 307985 0
Medical Research Future Fund, Department of Health, Australian Government
Country [1] 307985 0
Australia
Primary sponsor type
University
Name
The University of New South Wales
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 308706 0
None
Name [1] 308706 0
Address [1] 308706 0
Country [1] 308706 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307978 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 307978 0
97-105 Boundary Street, Darlinghurst NSW 2010
Ethics committee country [1] 307978 0
Australia
Date submitted for ethics approval [1] 307978 0
23/11/2020
Approval date [1] 307978 0
20/01/2021
Ethics approval number [1] 307978 0
2020/ETH02969

Summary
Brief summary
The TeleClinical Care-STOKE trial is a multicentre, prospective, randomised, blinded endpoint study. Patients discharged from hospital following an acute stroke/TIA will be randomised to management with the TCC-STROKE system or the standard of care for 6 months. The overall study aim is to demonstrate that a smartphone app-based system of transitional care following discharge from an acute stroke treatment centre can decrease hospital re-admission rates within six months. The primary hypothesis is that the TCC-STROKE system of transitional care will reduce the all cause hospital re-admission rate by 10%, relative to standard care, within six months of discharge following the index stroke event.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109114 0
Prof Ken Butcher
Address 109114 0
Level 1, South Wing, Edmund Blacket Building, Prince of Wales Hospital, 320-346 Barker St, Randwick NSW 2031
Country 109114 0
Australia
Phone 109114 0
+61293828821
Fax 109114 0
Email 109114 0
[email protected]
Contact person for public queries
Name 109115 0
Miss Kristin Economou
Address 109115 0
Level 1, South Wing, Edmund Blacket Building, Prince of Wales Hospital, 320-346 Barker St, Randwick NSW 2031
Country 109115 0
Australia
Phone 109115 0
+61293828891
Fax 109115 0
Email 109115 0
[email protected]
Contact person for scientific queries
Name 109116 0
Prof Ken Butcher
Address 109116 0
Level 1, South Wing, Edmund Blacket Building, Prince of Wales Hospital, 320-346 Barker St, Randwick NSW 2031
Country 109116 0
Australia
Phone 109116 0
+61293828821
Fax 109116 0
Email 109116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.