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Trial registered on ANZCTR


Registration number
ACTRN12614000081617
Ethics application status
Approved
Date submitted
9/01/2014
Date registered
22/01/2014
Date last updated
22/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Tablets and Technology During Stroke Recovery
Scientific title
Determining the effect of access to and use of tablet technology on stroke survivor quality of life.
Secondary ID [1] 283484 0
Nil
Universal Trial Number (UTN)
Trial acronym
TNT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290401 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290792 290792 0 0
Other physical medicine / rehabilitation
Stroke 291315 291315 0 0
Ischaemic
Stroke 291316 291316 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients in the intervention group will be given an iPad on discharge from inpatient rehabilitation. They will have it for 4 weeks and during this time will be able to use the iPad and the accompanying applications, in any way they so desire.
Applications loaded on the iPads given to patients will include but are not limited to those which by design facilitate: communication (ie. Speech Sounds on Cue, Conversation TherAppy), cognitive function (Memory, iMazing), dexterity (ie. Dexteria), movement (ie. physiotherapyexercises.com), socialisation (ie. Facebook, Safari for email access) and participation in fun leisure based games (ie. Angry Birds, Uno).

Frequency of use of computer technology (which includes tablet devices such as the iPad, but also computers/smart phones/iPods) will be collected in both the control and intervention group through weekly telephone surveys .
Intervention code [1] 288194 0
Other interventions
Comparator / control treatment
Standard post inpatient rehabilitation and care. Standard care is defined access to all the usual post-discharge services (ie. referral to outpatient therapy/day hospital programs/in home services) which is available within the patient's health service.
Control group
Active

Outcomes
Primary outcome [1] 290792 0
Quality of Life using the Stroke and Aphasia Quality of Life (SaQOL) survey
Timepoint [1] 290792 0
1 month post discharge from inpatient rehabilitation
Secondary outcome [1] 305294 0
Mood using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [1] 305294 0
1 month post discharge from inpatient rehabilitation
Secondary outcome [2] 305295 0
Cognition using the Montreal Cognitive Assessment Scale (MoCA)
Timepoint [2] 305295 0
1 month post discharge from inpatient rehabilitation
Secondary outcome [3] 305296 0
Communication using the Western Aphasia Battery (WAB)
Timepoint [3] 305296 0
1 month post discharge from inpatient rehabilitation
Secondary outcome [4] 305297 0
Self-efficacy using the Stroke Self- Efficacy Questionnaire
Timepoint [4] 305297 0
1 month post discharge from inpatient rehabilitation
Secondary outcome [5] 305298 0
Participation using the Activity Card Sort (ACS)
Timepoint [5] 305298 0
1 month post discharge from inpatient rehabilitation

Eligibility
Key inclusion criteria
Patient has been admitted for rehabilitation for a recent (<12 weeks ago) stroke (infarct or haemorrhagic)

Patient received training and used tablet technology (i.e. iPad) during their inpatient stay
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to follow one stage instructions

Pre-morbid or stroke related impairments preventing effective use of the iPad (may include cognition, motor planning or visual impairments)

Patient has arranged access to a tablet device to use after discharge

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)
Patients that are admitted for rehabilitation of their stroke that have been using an iPad during their admission will be invited to participate in TNT if they meet the aforementioned inclusion criteria.
Once a patient has given informed consent, the site coordinator will (I) collect baseline data including collection of demographic data, administer the pre-stroke technology survey and will administer a battery of measurement tools including the mRS, HADS, MoCA, WAB and SSEQ.
Once all baseline data has been collected, central randomisation by phone will occur (allocation concealment procedures). If randomised to intervention group, the participant will be given an iPad on discharge from the rehabilitation unit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
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
This is a pilot study and with 30 subjects per group will have a 50% chance of finding a 0.5 SD difference in mean quality of life between groups at the 5% significance level. Differences in quality of life will be tested using a t-test. The secondary outcomes of mood, cognitive function, communication, self-efficacy and activity participation will be tested using analysis of variance. All analyses will be performed using STATA 13.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/01/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1635 0
Rankin Park Centre for Rehabilitation and Aged Care
Recruitment hospital [2] 1636 0
Wingham Hospital
Recruitment hospital [3] 1637 0
The Maitland Hospital - Maitland
Recruitment postcode(s) [1] 7522 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 7524 0
2429 - Wingham
Recruitment postcode(s) [3] 7533 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 288190 0
Other
Name [1] 288190 0
Hunter Stroke Service
Hunter New England Local Health District
Country [1] 288190 0
Australia
Funding source category [2] 288351 0
Other
Name [2] 288351 0
Clinical Systems Team, Information Technology & Telecommunications
Hunter New England Local Health District
Country [2] 288351 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health- Hunter Stroke Service
Address
Level 2, The Lodge, Rankin Park Campus
Lookout Rd
New Lambton Heights NSW 2305.
Country
Australia
Secondary sponsor category [1] 286915 0
None
Name [1] 286915 0
Address [1] 286915 0
Country [1] 286915 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290119 0
Research Ethics and Governance Unit, Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290119 0
Locked bag 1
New Lambton, NSW, 2305
Ethics committee country [1] 290119 0
Australia
Date submitted for ethics approval [1] 290119 0
31/10/2013
Approval date [1] 290119 0
03/12/2013
Ethics approval number [1] 290119 0
13/11/20/5.09

Summary
Brief summary
TNT is a pilot randomised control trial to determine the effect that access to and use of tablet technology within the first month following inpatient stroke rehabilitation has on stroke survivor quality of life.

The primary aims of our pilot study TNT are to:

1. Determine the effect that access to and use of tablet use has on stroke survivor:quality of life, mood, cognition,
communication, self efficacy and activity participation.

2. Estimate the frequency and nature of tablet use when stroke survivors are given training and access to tablet
technology within the inpatient rehabilitation and community setting.

We hypothesise that stroke survivors who use an iPad during the first month following discharge from rehabilitation
will experience a better quality of life than those survivors who do not use this technology. Furthermore, we predict
there will be a trend towards better mood, cognition, communication, self efficacy and higher levels of activity
participation in survivors whom have access to iPads.
Data from this pilot RCT study will be used to inform the
design of future trials to determine the functional efficacy of tablet use during stroke rehabilitation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43966 0
Ms Heidi Janssen
Address 43966 0
Hunter Medical Research Institute
Lot 1 Kookaburra Crt,
New Lambton Heights NSW, 2305
Country 43966 0
Australia
Phone 43966 0
+61 02 40420417
Fax 43966 0
Email 43966 0
[email protected]
Contact person for public queries
Name 43967 0
Melanie Salaris
Address 43967 0
Aged Care and Rehabilitation Services Taree
Suite 2, 57-61 Albert St,
Taree NSW, 2430
Country 43967 0
Australia
Phone 43967 0
+61 02 65151820
Fax 43967 0
+61 02 65151801
Email 43967 0
[email protected]
Contact person for scientific queries
Name 43968 0
Heidi Janssen
Address 43968 0
Hunter Medical Research Institute
Lot 1 Kookaburra Crt,
New Lambton Heights NSW, 2305
Country 43968 0
Australia
Phone 43968 0
+61 02 40420417
Fax 43968 0
Email 43968 0
[email protected]

No information has been provided regarding IPD availability


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.