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Trial registered on ANZCTR


Trial ID
ACTRN12612000464864
Ethics application status
Approved
Date submitted
24/04/2012
Date registered
26/04/2012
Date last updated
27/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation to improve outcomes for people with stroke: The ACTIV trial.
Scientific title
Improving physical function for people with stroke: A randomised controlled trial comparing telerehabilitation, to augment an exercise programme, with a usual care control group.
Secondary ID [1] 280406 0
Nil
Universal Trial Number (UTN)
U1111-1130-0430
Trial acronym
ACTIV Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic Stroke 286295 0
Haemorrhagic Stroke 286380 0
Condition category
Condition code
Stroke 286535 286535 0 0
Haemorrhagic
Stroke 286536 286536 0 0
Ischaemic
Physical Medicine / Rehabilitation 286621 286621 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A six month intervention comprising four face to face physiotherapy sessions (consisting of exercises working towards a specific goal), five telephone calls and 1-2 text messages per week, to encourage continuation of the prescribed exercise plan. Each physiotherapy intervention will be approximately 45 mins in duration and will occur at baseline, after 2 weeks, 12 weeks and 24 weeks. The phone calls will be approximately 20 mins in duration and will occur at 1 week, 4 weeks, 8 weeks, 16 weeks and 20 weeks. The treating physiotherapist makes the phone calls and discusses whether the exercises have been managed and how the participant is working towards their goal. They discuss any barriers to exercise completion and make suggestions to modify the programme if problems are occurring. The exercises will consist of simple functional exercises such as sit to stand, walking and balance, which directly pertain to acheiving the desired goal. The therapist and participant between them will agree on when the exercises will be done, including how many, what level of difficulty and any safety concerns. The participant will then do the exercises in their own home.
Intervention code [1] 284691 0
Rehabilitation
Intervention code [2] 284714 0
Lifestyle
Comparator / control treatment
Usual care. No attempt will be made to influence any treatment or intervention sought by the control group, as the study is looking at effectiveness in a real world situation.
Control group
Active

Outcomes
Primary outcome [1] 286964 0
Physical function in people with stroke compared to a usual care control group as measured by the physical subcomponent of the SIS 3.0
Timepoint [1] 286964 0
Baseline, at 6 months (immediately after cessation of intervention)
Secondary outcome [1] 297060 0
Dynamic balance in people with stroke, compared to a usual care control group as measured by the Step test
Timepoint [1] 297060 0
Baseline, at 6 months (immediately after cessation of intervention) and at 12 months (6 months after cessation of intervention)
Secondary outcome [2] 297061 0
Grip strength in people with stroke, compared to a usual care control group as measured by the Jaymar hand held dynamometer
Timepoint [2] 297061 0
Baseline, at 6 months (immediately after cessation of intervention) and at 12 months (6 months after cessation of intervention)
Secondary outcome [3] 297062 0
The confidence of people with stroke in their ability to undertake daily tasks as measured by the Stroke self-efficacy questionnaire (SSEQ)
Timepoint [3] 297062 0
Baseline, at 6 months (immediately after cessation of intervention) and at 12 months (6 months after cessation of intervention)
Secondary outcome [4] 297063 0
Changes in health outcomes and the impact the stroke has had in various areas of the participants life, using all eight domains and the overall stroke recovery rating of the SIS 3.0
Timepoint [4] 297063 0
Baseline, at 6 months (immediately after cessation of intervention) and at 12 months (6 months after cessation of intervention)
Secondary outcome [5] 297064 0
Hospital and residential care admission rates. Admissions to both short and long term hospitals will be collected from electronic records and stroke participant/carer responses.
Timepoint [5] 297064 0
Monthly phone calls for 6 months and at 12 months
Secondary outcome [6] 297065 0
Cost and cost effectiveness of the ACTIV programme. Information on costs will be collected via electronic records and stroke participants/carers survey responses and will be reported for one year post stroke and modelled over the lifetime post stroke.
Cost effectiveness of the intervention, the cost of health services usage obtained from electronic records and the survey responses will be compared between the two groups. Responses to the EQ 5D and willingness to pay for the services will be compared to ascertain the cost utility and cost benefit of the intervention
Timepoint [6] 297065 0
Baseline, at 6 months (immediately after cessation of intervention), at 12 months (6 months after cessation of intervention)
Secondary outcome [7] 297132 0
The experience of and satisfaction with the ACTIV programme from those people in the intervention group, using semi structured interviews with sampling from a variety of geographical areas, socioeconomic groups and with varying levels of baseline mobility.
Timepoint [7] 297132 0
At 6 months which is the conclusion of the intervention.
Secondary outcome [8] 312046 0
Physical function in people with stroke compared to a usual care control group as measured by the physical subcomponent of the SIS 3.0
Timepoint [8] 312046 0
12 months (6 months after cessation of intervention)

Eligibility
Key inclusion criteria
Have had a first ever stroke of haemorrhagic or ischaemic origin. Are over the age of 20 years, have been discharged from their District Health Board, inpatient, outpatient and community physiotherapy services to live in their own home (participants involved in other forms of therapy such as OT, Tai Chi or community exercise programmes will not be excluded) Have medical clearance from their GP to participate in a low to moderate level activity programme Score at least 3 on a telephone cognitive screening questionnaire (Callahan et al 2002) Have a limitation in physical function of leg, arm or both and have had their stroke less than 18 months ago
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have a brain stem or cerebellar stroke that has been confirmed by a medial practitioner.
Are unable to understand and speak basic level English

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)
Enrolment will occur in New Zealand in the North Island at Middlemore Hospital (South Auckland), North Shore Hospital (North Auckland) and in the South Island at Princess Margaret Hospital (Christchurch), and Dunedin Hospital (Dunedin). In addition to the hospital recruitment, advertisements will be placed in local newspapers and in the Stroke foundation newsletter. These will alert people to the trial, who may have moved to the area since their stroke, or not been admitted to hospital. It will also include people who were not initially keen to join but changed their mind at a later date. Randomisation will be stratified by centre (4 locations) with recruitment targets of 32 participants from each of the North Island centres and 16 from each of the South Island centres, to proportionately represent the number of stroke admissions expected in each location. Stratified randomisation will be used according to centre and baseline mobility. Baseline mobility will be decided on the Functional Ambulation Classification: either ‘less mobile’ if they have a level of five or below or ‘more mobile’ if they have a level of six.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation software will be coded and tested by the study statistician, then handed over to a third independent party for random number generator seeding, execution of allocation and day-to-day management of the randomisation. The recruiters, assessors and personnel involved in data management and analysis will be blinded to treatment assignment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4262 0
New Zealand
State/province [1] 4262 0

Funding & Sponsors
Funding source category [1] 285110 0
Government body
Name [1] 285110 0
Health Research Council
Address [1] 285110 0
Level 3, 110 Stanley Street
Auckland 1010
Country [1] 285110 0
New Zealand
Primary sponsor type
Individual
Name
Denise Taylor
Address
AUT University
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284011 0
Individual
Name [1] 284011 0
Nicola Saywell
Address [1] 284011 0
AUT University
Private Bag 92006
Auckland 1142
Country [1] 284011 0
New Zealand
Other collaborator category [1] 260764 0
Individual
Name [1] 260764 0
Alain Vandal
Address [1] 260764 0
AUT University
Private Bag 92006
Auckland 1142
Country [1] 260764 0
New Zealand
Other collaborator category [2] 260765 0
Individual
Name [2] 260765 0
Leigh Hale
Address [2] 260765 0
University of Otago
PO Box 56
Dunedin 9054
Country [2] 260765 0
New Zealand
Other collaborator category [3] 260766 0
Individual
Name [3] 260766 0
Carl Hanger
Address [3] 260766 0
Princess Margaret Hospital
Canterbury DHB
PO Box 800
Christchurch 8140
Country [3] 260766 0
New Zealand
Other collaborator category [4] 260767 0
Individual
Name [4] 260767 0
Stephan Milosavljevic
Address [4] 260767 0
University of Otago
PO Box 56
Dunedin 9054
Country [4] 260767 0
New Zealand
Other collaborator category [5] 260768 0
Individual
Name [5] 260768 0
Suzie Mudge
Address [5] 260768 0
AUT University
Private Bag 92006
Auckland 1142
Country [5] 260768 0
New Zealand
Other collaborator category [6] 260769 0
Individual
Name [6] 260769 0
Paul Brown
Address [6] 260769 0
University of California
5200 North Lake Rd
Merced
CA 95343
Country [6] 260769 0
United States of America
Other collaborator category [7] 260770 0
Individual
Name [7] 260770 0
Valery Feigin
Address [7] 260770 0
AUT University
Private Bag 92006
Auckland 1142
Country [7] 260770 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287119 0
Multi-region ethics committee
Ethics committee address [1] 287119 0
c/-Ministry of Health
PO Box 5013
1 The Terrace
Wellington 6011
Ethics committee country [1] 287119 0
New Zealand
Date submitted for ethics approval [1] 287119 0
Approval date [1] 287119 0
14/02/2012
Ethics approval number [1] 287119 0
MEC_11_11_089

Summary
Brief summary
In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. This leads to reduced function over time; however, evidence indicates that participation in physical interventions prevents this functional decline. Whether a person receives ongoing stroke services is often related to factors, such as whether resources are available and geographical location. This trial will determine if the Augmented Community Telerehabilitation Intervention (ACTIV) programme supports people with stroke in the transition from rehabilitation to independence and if that results in better outcomes and quality of life. The ACTIV programme is a low cost intervention and uses readily available technologies, such as telephone and mobile phones combined with face-to-face visits from a physiotherapist to help people with stroke resume activities they enjoyed doing before the stroke. In-depth interviews will also be used to explore the experiences of people with the intervention. Measures of cost will be collected to evaluate the cost-effectiveness of the intervention.
Trial website
Trial related presentations / publications
Public notes
After discussion with the statistician the trial follow-up period was extended to allow analysis of the 6 and 12-month follow-up to be completed unblinded. This has now occurred.

Contacts
Principal investigator
Name 34072 0
Dr Denise Taylor
Address 34072 0
c/- AUT University 90 Akoranga Dr Northcote Auckland 1142 OR Private Bag 92006 Auckland
Country 34072 0
New Zealand
Phone 34072 0
+6499219999
Fax 34072 0
Email 34072 0
detaylor@aut.ac.nz
Contact person for public queries
Name 17319 0
Ms Nicola Saywell
Address 17319 0
c/- AUT University
90 Akoranga Dr
Northcote
Auckland 1142
OR
Private Bag 92006
Auckland 1142
Country 17319 0
New Zealand
Phone 17319 0
+6499219999
Fax 17319 0
+6499219620
Email 17319 0
nsaywell@aut.ac.nz
Contact person for scientific queries
Name 8247 0
Dr Denise Taylor
Address 8247 0
c/- AUT University
90 Akoranga Dr
Northcote
Auckland 1142
OR
Private Bag 92006
Auckland
Country 8247 0
New Zealand
Phone 8247 0
+6499219999
Fax 8247 0
Email 8247 0
detaylor@aut.ac.nz