Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000051448
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
20/01/2016
Date last updated
30/01/2020
Date data sharing statement initially provided
30/01/2020
Date results information initially provided
30/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an activity monitor and smart device application improve the intensity of therapy after stroke?
Scientific title
Can an activity monitor and smart device application improve the intensity of therapy after stroke? - a feasibility study
Secondary ID [1] 288254 0
Nil known
Universal Trial Number (UTN)
Trial acronym
INTERAct
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 297190 0
Condition category
Condition code
Stroke 297407 297407 0 0
Ischaemic
Stroke 297408 297408 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sit to stand is a common functional exercise prescribed by physiotherapists. The intervention in this study involves completing a set number of a sit to stand exercise per day which will be monitored with a device connected to an app. The app will providing feedback to the patient and enable the therapist to see the number of sit to stands performed by the patients remotely. The therapist will also be able to change the number of sit to stand goal remotely via a function on the application.
Participants will be instructed in their home on how to use the sit to stand activity monitor (AM) and smart device application (on participants own iPhone, iPad or project provided tablet). The AM consists of a small pressure sensor which is placed under a nominated chair in the participant’s home. Participants will use the AM for the 5-week study period and track their number of daily sit to stand repetitions. At the start of weeks 2-5 the research therapist will review the participant’s results remotely via the internet and set a target for the participant for the following week based on the number of sit to stands performed each day in the preceding week. The weeks goal will be programmed remotely into the smart device application (and phone call if necessary). Participants will connect to the smart device application to get feedback on how close they are to their goal or whether they have achieved the day’s target. Results will be available to the research therapist remotely.
Intervention code [1] 293544 0
Rehabilitation
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296963 0
Adherence to set program (number of sit to stands in weeks 2-5 measured by the activity monitor / set target on the smart device application).
Timepoint [1] 296963 0
Weeks 2 - 5
Primary outcome [2] 296964 0
Usability and acceptability of activity monitor & smart device app: System usability scale
Timepoint [2] 296964 0
End of week 5
Secondary outcome [1] 319778 0
Helpfulness and enjoyment of activity monitor and app: Physical activity enjoyment scale
Timepoint [1] 319778 0
End week 5
Secondary outcome [2] 319779 0
Ease of delivering the exercise upgrades remote via internet connected smart device: System usability scale (therapist)
Timepoint [2] 319779 0
End of week 5
Secondary outcome [3] 319855 0
Number of sit to stands in 2 minutes; Short Physical Performance Battery (sit to stand, balance, gait)
Timepoint [3] 319855 0
Baseline and end of week 5

Eligibility
Key inclusion criteria
1) 12 months or less post diagnosis of stroke 2) Living in the community 3) Age >=18 years 4) Able to perform sit to stand independently
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Living in a nursing home 2) Unable to follow instructions sufficiently to participate in the intervention 3) Medically unstable

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
feasibility study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Adherence will be described as percentage equal to the number performed/target. Participant perceptions (primary outcomes 2 and 3) of the technology will be described using frequency counts and percentages for each likert scale from the questionnaires. Changes in secondary outcome measures will be performed using t-tests or non-parametric tests to compare normally and non-normally distributed data respectively.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2016
Actual
1/02/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
4/09/2017
Date of last data collection
Anticipated
4/09/2017
Actual
9/10/2017
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment postcode(s) [1] 12511 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 292640 0
Charities/Societies/Foundations
Name [1] 292640 0
Royal Hobart Hospital Research Foundation
Country [1] 292640 0
Australia
Primary sponsor type
Individual
Name
Dr Michele Callisaya
Address
Menzies Institute of Medical Research
17 Liverpool Street,
Hobart Tasmania
7000
Country
Australia
Secondary sponsor category [1] 291385 0
None
Name [1] 291385 0
None
Address [1] 291385 0
None
Country [1] 291385 0
Other collaborator category [1] 278763 0
Individual
Name [1] 278763 0
Prof Stuart Smith
Address [1] 278763 0
University of the Sunshine Coast &
Sunshine Coast Inc,
PO Box 596, Maroochydore QLD 4558
Country [1] 278763 0
Australia
Other collaborator category [2] 278764 0
Individual
Name [2] 278764 0
Dr Matthew Schmidt
Address [2] 278764 0
University of Tasmania
17 Liverpool Street
Hobart Tasmania
7000
Country [2] 278764 0
Australia
Other collaborator category [3] 278765 0
Individual
Name [3] 278765 0
Miss Dawn Simpson
Address [3] 278765 0
Menzies Institute of Medical Research
17 Liverpool Street
Hobart Tasmania
7000
Country [3] 278765 0
Australia
Other collaborator category [4] 278766 0
Individual
Name [4] 278766 0
Dr Marie-Louise Bird
Address [4] 278766 0
University of Tasmania
Newnham Campus
University of Tasmania
Locked Bag 1362
Launceston Tasmania 7250
Country [4] 278766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294116 0
Human Research Ethics Committee (Tasmania)
Ethics committee address [1] 294116 0
Office of Research Services
University of Tasmania
Private bag 1
Hobart
Tasmania
7001
Ethics committee country [1] 294116 0
Australia
Date submitted for ethics approval [1] 294116 0
11/05/2015
Approval date [1] 294116 0
25/06/2015
Ethics approval number [1] 294116 0
H0014859

Summary
Brief summary
Current stroke guidelines recommend as much physical practice as possible in the first 6 months after stroke. A number of recent reviews concluded that therapy should include intensive repetitive task training to improve functional outcomes (such as the ability to transfer and walk).
However, a number of factors can lead to patients remaining inactive, particularly once home.
1) Limitations of outpatient therapy: Frequency of appointments is low and programs are time limited in duration.
2) Motivation and confidence: Low motivation and lack of a therapist monitoring practice can contribute to poor adherence to exercise. Providing accurate feedback, goal setting and rewards can enhance compliance and self efficacy.
3) Geographical location: Patients may live in remote or rural areas resulting in less access to specialist rehabilitation services or have limited access to transport to attend therapy.
Novel, cost-effective and enjoyable ways are needed to increase the intensity of practice outside of centre-based therapy.
Therefore, the purpose of this study is to investigate whether for people who have had a stroke:
1. a smart device application and activity monitor (AM) can be used to increase repetitions of a functional exercise outside of centre-based therapy
2. the activity monitor and smart device application package is enjoyable, acceptable and easy to use.
3. progression of intensity of practice can be delivered remotely by a therapist via the internet.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62534 0
Dr Michele Callisaya
Address 62534 0
Menzies Institute of Medical Research
Private Bag 23
Hobart
Tasmania
7001
Country 62534 0
Australia
Phone 62534 0
+61 418295933
Fax 62534 0
Email 62534 0
[email protected]
Contact person for public queries
Name 62535 0
Dr Michele Callisaya
Address 62535 0
Menzies Institute of Medical Research
Private Bag 23
Hobart
Tasmania
7001
Country 62535 0
Australia
Phone 62535 0
+61 418295933
Fax 62535 0
Email 62535 0
[email protected]
Contact person for scientific queries
Name 62536 0
Dr Michele Callisaya
Address 62536 0
Menzies Institute of Medical Research
Private Bag 23
Hobart
Tasmania
7001
Country 62536 0
Australia
Phone 62536 0
+61 418295933
Fax 62536 0
Email 62536 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 de-identified individual participant data
When will data be available (start and end dates)?
from now for 5 years
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Those that meet the aims of the approved proposal
How or where can data be obtained?
Request to CI and via signing a data sharing agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes DOI: 10.1080/10749357.2019.1690779 Published 25 N... [More Details]
Plain language summaryNo It was safe and feasible to prescribe, monitor and... [More Details]

Documents added automatically
No additional documents have been identified.