Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000418976p
Ethics application status
Submitted, not yet approved
Date submitted
30/01/2020
Date registered
30/03/2020
Date last updated
30/03/2020
Date data sharing statement initially provided
30/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
iN home Telerehabilitation to ENhance phySIcal activiTY after Stroke (iNTENSITY - Stroke)
Scientific title
The efficacy of home-delivered telerehabilitation compared with centre-based community rehabilitation on time spent physically active in people with stroke: a pilot randomized controlled trial
Secondary ID [1] 300164 0
Nil known
Universal Trial Number (UTN)
Trial acronym
iNTENSITY - Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke Rehabilitation 315711 0
Condition category
Condition code
Stroke 313996 313996 0 0
Ischaemic
Stroke 313997 313997 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 cohorts: Participants will be randomised to a home-delivered telerehabilitation or centre-based community rehabilitation cohort.

Participants will receive 6 weeks of rehabilitation delivered over a 6-8 weeks period. Both groups will receive the same amount of total scheduled therapy time related to physical activity: Totaling 2 hours of Physiotherapy and/or Occupational Therapy time and 2 hours of Allied Health Assistant therapy time per week.

Both intervention arms will provide individually tailored task-specific exercises targeting physical activity. In addition, both intervention arms will coach, educate and mentor participants in self-managing their physical activities in daily life. Further, both interventions will use patient specific goal setting and follow therapy recommendations as outlined by the Australian Stroke National Guidelines. The need for physiotherapy or occupational therapy, including duration of sessions will be determined based on how participants can best achieve their specific goals.

Intervention administration:
Participants randomised to home-delivered telerehabilitation will receive rehabilitation delivered at their residential address through a technology device e.g. tablet, computer.
Participants will receive 2 hours rehabilitation from a physiotherapist and/or occupational therapist and 2 hours of rehabilitation delivered from an Allied Health Assistant per week.

Participants randomised to centre-based community rehabilitation will travel to their nearest centre for rehabilitation. Patient will receive 2 hours rehabilitation from a physiotherapist and/or occupational therapist and 2 hours of rehabilitation delivered from an Allied Health Assistant per week.

Mode of therapy administration:
Participants randomised to home-delivered telerehabilitation will receive rehabilitation delivered through a technology device.
Participants randomised to centre-based rehabilitation will be delivered in a one-on-one or/and in a group session (max 8 people).

All aspects of the delivered therapy will be monitored and recorded:
Service delivery fidelity
1) Start and end time of intervention session
2) Health professional involved (PT/OT or AHA)
3) Frequency of sessions/ total sessions
4) Attendance/ cancelled/ did not attend/ rescheduled (includes reason technology failures)
5) Caregiver attendance Y/N – Caregiver presence required Y/N

Therapy content fidelity
1) Content of sessions in ‘active minutes’ spent on physical activity
2) Content of sessions in minutes on rest, self-management, education, goal setting, documentation, and other non-patient contact time.
3) Time to set up session
Intervention code [1] 316441 0
Rehabilitation
Comparator / control treatment
Centre-based community rehabilitation
Control group
Active

Outcomes
Primary outcome [1] 322403 0
Step count measured through the ActivPAL activity monitor will be collected to reflect daily physical activity post intervention
Timepoint [1] 322403 0
End of intervention
Primary outcome [2] 322829 0
Upper limb activity measured via ActiGraph activity monitors will be collected to reflect daily physical activity post intervention
Timepoint [2] 322829 0
End of Intervention
Secondary outcome [1] 378370 0
Walking ability (10 meter walk test)
Timepoint [1] 378370 0
End of intervention and 6 months post stroke
Secondary outcome [2] 378371 0
Upper limb function: Action Research Arm Test
Timepoint [2] 378371 0
End of intervention and 6 months post stroke
Secondary outcome [3] 378372 0
Level of disability: modified Rankin Scale
Timepoint [3] 378372 0
End of intervention and 6 months post stroke
Secondary outcome [4] 378373 0
Anxiety and depression: Hospital Anxiety and Depression Scale
Timepoint [4] 378373 0
End of intervention and 6 months post stroke
Secondary outcome [5] 378374 0
Fatigue levels: Fatigue Assessment Scale
Timepoint [5] 378374 0
End of intervention and 6 months post stroke
Secondary outcome [6] 379736 0
Safety - registering adverse and serious adverse events through participant reported and medical record review e.g. falls, delirium, pneumonia, stroke
Timepoint [6] 379736 0
End of intervention and 6 months post stroke
Secondary outcome [7] 379737 0
Patient reported outcomes of self-efficacy: Stroke Self-Efficacy Questionnaire
Timepoint [7] 379737 0
End of intervention and 6 months post stroke
Secondary outcome [8] 379738 0
Patient reported outcomes of quality of life (EQ-5D-5L)
Timepoint [8] 379738 0
End of intervention and 6 months post stroke
Secondary outcome [9] 379739 0
Economic analysis of patient and health care provider costs.
Patient-associated cost will include travel and associated carer time, and cost of travel to and from appointments. Health care provider costs will include cost per appointment using standardized government charges for in-person allied health therapy appointments, and for clinician time related to telerehabilitation appointments. Costs will be collected directly from the trial for intervention and control arm costs and additional costs will be collected using a patient diary.
Timepoint [9] 379739 0
End of intervention
Secondary outcome [10] 379740 0
Sustainability of daily physical activity: step count, measured through the ActivPAL activity monitor
Timepoint [10] 379740 0
6 months post stroke
Secondary outcome [11] 379741 0
Sustainability of daily physical activity: upper limb activity measured through the ActiGraph activity monitor
Timepoint [11] 379741 0
6 months post stroke

Eligibility
Key inclusion criteria
>18 years of age
First or recurrent stroke (ischemic and hemorrhagic)
A modified Rankin Scale (mRS) of 1, 2, 3 or 4 on discharge from hospital (acute or subacute inpatient)
Presence of motor impairments
Able to engage in rehabilitation through information technology
Own technology device (or loan tablet) and data plan to support telerehabilitation
Able to sign consent or has a substitute decision maker who can sign consent (pending governance approvals for substitute decision maker consent from QCAT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Premorbid mRS>3
Concurrent progressive neurologic disorder including severe dementia
End-stage medical/ palliative conditions with life expectancy <6 months
Severe aphasia (unable to follow one stage commands)

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)
Randomization will be independent and concealed using an allocation sequence generated by an independent researcher not involved in the study. Group allocation will be stored in opaque sealed envelopes across the two different strata (60 envelopes in each strata to allow for sufficient numbers) in order to provide secure randomization.

Participants will be stratified using their modified Rankin Scale (mRS) at time of discharge from hospital. We will use two strata: 1) participants with mRS 1+2, and 2) participants with mRS 3+4 on discharge from hospital (acute or subacute inpatient).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to group will occur in random permuted blocks so that after every block from each strata (4-6 participants) the experimental and control group will contain equal numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sixty people with stroke will be recruited, 30 allocated to experimental (home-delivered telerehabilitation) and 30 to control (centre-based community rehabilitation). This number is considered sufficient to estimate point measures and provide precise estimates of variance with a main trial designed with 90% power, two-sided 5% significance and a small effect size (0.2). This includes allowance for 15% potential drop outs. Linear mixed models will be used to determine the effect of group, time and interactions on outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
1/05/2022
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15566 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [2] 15567 0
Nambour General Hospital - Nambour
Recruitment hospital [3] 15568 0
Gympie Hospital - Gympie
Recruitment postcode(s) [1] 28940 0
4575 - Birtinya
Recruitment postcode(s) [2] 28941 0
4560 - Nambour
Recruitment postcode(s) [3] 28942 0
4570 - Gympie

Funding & Sponsors
Funding source category [1] 304604 0
Government body
Name [1] 304604 0
Queensland Government, Department of Health; Health Practitioners Research Scheme 2019
Country [1] 304604 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast Hospital and Health Service
Address
Sunshine Coast University Hospital
6 Doherty Street
Birtinya 4575 QLD
Country
Australia
Secondary sponsor category [1] 304896 0
None
Name [1] 304896 0
Address [1] 304896 0

Country [1] 304896 0
Other collaborator category [1] 281125 0
University
Name [1] 281125 0
The University of Queensland
Address [1] 281125 0
School of Health and Rehabilitation Sciences
Therapy Building 84A
St Lucia 4072 QLD
Country [1] 281125 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305024 0
Human Research Ethics Committee The Prince Charles Hospital
Ethics committee address [1] 305024 0
Ethics committee country [1] 305024 0
Australia
Date submitted for ethics approval [1] 305024 0
02/01/2020
Approval date [1] 305024 0
Ethics approval number [1] 305024 0
Ethics committee name [2] 305025 0
Human Research Ethics Committee The University of Queensland
Ethics committee address [2] 305025 0
Ethics committee country [2] 305025 0
Australia
Date submitted for ethics approval [2] 305025 0
20/02/2020
Approval date [2] 305025 0
Ethics approval number [2] 305025 0

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

Contacts
Principal investigator
Name 99010 0
Dr Ingrid Rosbergen
Address 99010 0
Sunshine Coast University Hospital
Allied Health Services, Stroke Unit 4A
6 Doherty Street
Birtinya 4575 QLD
Country 99010 0
Australia
Phone 99010 0
+61 7 5202 8424
Fax 99010 0
+61 7 5202 0433
Email 99010 0
[email protected]
Contact person for public queries
Name 99011 0
Ingrid Rosbergen
Address 99011 0
Sunshine Coast University Hospital
Allied Health Services, Stroke Unit 4A
6 Doherty Street
Birtinya 4575 QLD
Country 99011 0
Australia
Phone 99011 0
+61 7 5202 8424
Fax 99011 0
+61 7 5202 0433
Email 99011 0
[email protected]
Contact person for scientific queries
Name 99012 0
Ingrid Rosbergen
Address 99012 0
Sunshine Coast University Hospital
Allied Health Services, Stroke Unit 4A
6 Doherty Street
Birtinya 4575 QLD
Country 99012 0
Australia
Phone 99012 0
+61 7 5202 8424
Fax 99012 0
+61 7 5202 0433
Email 99012 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?
All deidentified participant data
When will data be available (start and end dates)?
Following publication - end date January 2025
Available to whom?
Researchers who provide a methodologically sound proposal at the discretion of the study team and Sunshine Coast Hospital and Health Service, Research Governance Officer.
Available for what types of analyses?
To achieve aims of approved proposals and for meta- analyses
How or where can data be obtained?
Email principal investigator (using contact information in ANZCTR record). Access following signed agreement for data sharing.


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.