None listed
Conditions
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.
Interventions
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 usin
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.
Sponsors
The University of New South Wales
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 or inpatient rehabilitation • Informed consent obtained from either the patient or substitute decision maker prior to any study related procedures being performed.
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.
Outcome results
None listed