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Trial registered on ANZCTR


Trial ID
ACTRN12613000779774
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
12/07/2013
Date last updated
12/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
CARE4STROKE: Caregiver mediated exercises with E-health support to improve intensity of training after stroke.
Scientific title
CARE4STROKE: The effect of caregiver mediated exercises with E-health support to improve intensity of training on physical mobility and length of stay in patients with stroke.
Secondary ID [1] 282629 0
None
Universal Trial Number (UTN)
Trial acronym
CARE4STROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility impairment after stroke 289323 0
Condition category
Condition code
Stroke 289664 289664 0 0
Ischaemic
Stroke 289665 289665 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 289867 289867 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CARE4STROKE programme consists of 8 weeks of complementary exercise therapy done with a caregiver, next to the usual therapy. Thirty-one standardized exercises are available, that can be customized per patient and caregiver to the individual situation. The exercises can be presented in a book version with photos and text or in a smartphone/ tablet app with video's and voiceover. The exercises are aimed at improving skills related to walking ability like sitting, standing and making transfers, or are supporting exercises to improve mobility, strength and balance. The patient and their caregiver are asked to do the exercises for the length of 8 weeks, minimally 5 times a week for 30 minutes. Additionally, participants in the intervention group will wear the fitbit for the length of 8 weeks after randomization. The fitbit activity monitor is a portable lightweight clip-on device which aims to empower and encourage activity by provided real-time feedback on e.g. number of steps taken, distance covered and number of calories burned. During the 8-week intervention period patients and their caregiver will have a weekly session (approximately 30 min) with a trained therapist. In this session, the participating couple will be instructed as to which exercises should be performed safely during the next week and evaluate the exercises done last week. The programme starts when the patient is admitted to hospital. When the discharge date of the patient is earlier than the finishing of the programme, the programme continues at home (up to 8 weeks from randomisation). Tele-rehabilitation services will allow for instructions of the physical therapists including monitoring progress of patients by e-Health services including telephone conferencing based counselling (frequency as required) and weekly visits by a coordinating physical therapist from the setting of discharge.
Intervention code [1] 287296 0
Rehabilitation
Comparator / control treatment
Usual rehabilitation care: interdisciplinary rehabilitation following the standards outlined by the clinical guidelines for stroke management (addressing mobility impairment, dysphagia or communication difficulties, upper limb activity, sensorimotor impairment, activities of daily living, cognition etc.)
Control group
Active

Outcomes
Primary outcome [1] 289744 0
Stroke Impact Scale immediately post-intervention (patient)
Timepoint [1] 289744 0
At 8 weeks
Secondary outcome [1] 303158 0
Length of stay (patient)
Timepoint [1] 303158 0
At discharge
Secondary outcome [2] 303159 0
Rivermead mobility index (patient)
Timepoint [2] 303159 0
At 8 and 12 weeks
Secondary outcome [3] 303160 0
Walking ability with 10-m timed walk and Timed up and go test (patient)
Timepoint [3] 303160 0
At 8 and 12 weeks
Secondary outcome [4] 303161 0
Nottingham extended ADL (patient)
Timepoint [4] 303161 0
At 8 and 12 weeks
Secondary outcome [5] 303162 0
Modified Rankin Scale (patient)
Timepoint [5] 303162 0
At 8 and 12 weeks
Secondary outcome [6] 303163 0
Fugl Meyer (FM) lower extremity (patient)
Timepoint [6] 303163 0
At 8 and 12 weeks
Secondary outcome [7] 303164 0
Motricity Index (patient)
Timepoint [7] 303164 0
At 8 and 12 weeks
Secondary outcome [8] 303165 0
Berg Balance Scale (patient)
Timepoint [8] 303165 0
At 8 and 12 weeks
Secondary outcome [9] 303166 0
Activity levels, measured with activPAL (patient)
Timepoint [9] 303166 0
At 8 and 12 weeks
Secondary outcome [10] 303167 0
Expanded Caregiver Strain Index (caregiver)
Timepoint [10] 303167 0
At 8 and 12 weeks
Secondary outcome [11] 303168 0
Amount of (additional) practice done measured with a diary (both)
Timepoint [11] 303168 0
At 8 and 12 weeks
Secondary outcome [12] 303169 0
Satisfaction with the intervention, measured by purpose-made questionnaire (both)
Timepoint [12] 303169 0
At 8 and 12 weeks
Secondary outcome [13] 303170 0
Hospital Anxiety and Depression Scale (both)
Timepoint [13] 303170 0
At 8 and 12 weeks
Secondary outcome [14] 303171 0
Fatigue Severity Scale (both)
Timepoint [14] 303171 0
At 8 and 12 weeks
Secondary outcome [15] 303172 0
Stroke Impact Scale (patient)
Timepoint [15] 303172 0
At 12 weeks
Secondary outcome [16] 303231 0
CarerQOL (caregiver)
Timepoint [16] 303231 0
At 8 and 12 weeks
Secondary outcome [17] 303589 0
The Modified Computer Self Efficacy Scale (both)
Timepoint [17] 303589 0
Baseline
Secondary outcome [18] 303590 0
The System Usability Scale (both)
Timepoint [18] 303590 0
At 8 weeks

Eligibility
Key inclusion criteria
Inclusion criteria for the patient:
- 18 years or older
- able to understand the English language
- able to appoint a caregiver
- being in the early rehabilitation phase (24 hours- 3 months)
- being able to follow instructions (a MMSE score > 23 points)
- Functional Ambulation Score (FAC) < 5
- a score of <11 on the Hospital Anxiety and Depression Scale (HADS)

Inclusion criteria for the caregiver:
- 18 years or older
- able to understand the English language
- a score of <11 on the Hospital Anxiety and Depression Scale (HADS)
- medically stable and physically able to perform the exercises together with the patient
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for both patient and caregiver will be serious comorbidity which interferes with participation.

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Descriptive statistics: Participation rate, compliance, satisfaction with the intervention and safety of the intervention will be reported as nominal variables to assess the feasibility. This will include frequencies, means and standard deviations. Most of the patient and caregiver characteristics will be considered as qualitative, categorical variables.

Univariate analysis: Baseline characteristics will be presented and between group differences will be studied to determine whether groups are comparable at baseline. When these data are not normally distributed, non-parametric Wilcoxon signed rank sum test will be used. When the data are normally distributed student t-test will be used. Alpha will be set at 0.05.

Multivariate analysis: The main outcomes will be compared between the intervention and control group at the different timepoints T0, T1, T2 using repeated measures Analysis Of Variance with factors group (2 levels) and time (3 levels) when the data are normally distributed. The Kruskal-Wallis test will be used when the data is not normally distributed. Alpha will be set at 0.05. SPSS version 20 will be used for all analyses.

We expect a significant reduction of 11% (5 points) in the self-reported mobility domain of the SIS version 3.0 (van de Port 2012) in favour of those patients who are allocated to the experimental group. ICC is known to be about 0.9. We expect minimally 28 patients are required per arm of the trial. Expecting a drop-out rate of 10%, we suppose that a minimum of 62 stroke patients are required to achieve a sufficient statistical power of 80%.

Recruitment
Recruitment status
Not yet recruiting
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 in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1091 0
Flinders Medical Centre
Recruitment hospital [2] 1092 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 287408 0
Hospital
Name [1] 287408 0
Hospital Trust Funds
Address [1] 287408 0
Repatriation General Hospital
216 Daws Rd
Daw Park SA 5041, Australia
Country [1] 287408 0
Australia
Funding source category [2] 287591 0
Government body
Name [2] 287591 0
NHMRC Partnership Grant Cognitive Impairment and Physical Conditions
Address [2] 287591 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [2] 287591 0
Australia
Primary sponsor type
Individual
Name
Prof Maria Crotty
Address
Flinders University School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital
Daws Road
Daw Park, South Australia, 5041
Country
Australia
Secondary sponsor category [1] 286162 0
None
Name [1] 286162 0
Address [1] 286162 0
Country [1] 286162 0
Other collaborator category [1] 277446 0
Hospital
Name [1] 277446 0
VU University Medical Center
Unit Neurorehabilitation
Address [1] 277446 0
Dept. of Rehabilitation Medicine
Boelelaan 1117
1081 HV Amsterdam
Country [1] 277446 0
Netherlands
Other collaborator category [2] 277447 0
Hospital
Name [2] 277447 0
Reade center for rehabilitation and rheumatology
Address [2] 277447 0
Overtoom 283
1054 HW Amsterdam
Country [2] 277447 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289382 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 289382 0
The Flats, G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
BEDFORD PARK SA 5042
Ethics committee country [1] 289382 0
Australia
Date submitted for ethics approval [1] 289382 0
Approval date [1] 289382 0
07/06/2013
Ethics approval number [1] 289382 0
167.13

Summary
Brief summary
Several systematic reviews have indicated that additional exercise therapy and repetitive task training have a significant effect on functional outcome after stroke. Guidelines therefore conclude that patients in a rehabilitation setting should have the opportunity to get an increase of intensity of therapy. A new method to meet these recommendations could be to involve caregivers (partner, family, friends) in exercise training. Previous studies suggest that this form of exercises done with a caregiver can lead to a better functional outcome for the patient and less strain for the caregiver.
This feasibility study will test the proof of concept of caregiver mediated exercises when combined with innovative ICT techniques (CARE4STROKE package) aimed at improving gait, ADL independency and allowing early discharge to patients own home setting after stroke.
We hypothesize that patients allocated to the CARE4STROKE programme will show better outcomes in terms of gait, gait-related activities and ADL with a reduced length of stay (LOS) when compared to usual care alone. In addition we hypothesize that this programme leads to increased levels of self-efficacy for patient and caregiver and a reduced caregiver burden.
This study is related to the CARE4STROKE trial registered on NTR with ID: NTR3739.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40574 0
Prof Maria Crotty
Address 40574 0
Flinders University School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital
Daws Road
Daw Park, South Australia, 5041
Country 40574 0
Australia
Phone 40574 0
+61 (8) 8275 1103
Fax 40574 0
Email 40574 0
maria.crotty@health.sa.gov.au
Contact person for public queries
Name 40575 0
Dr Maayken van den Berg
Address 40575 0
Flinders University School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital
Daws Road
Daw Park, South Australia, 5041
Country 40575 0
Australia
Phone 40575 0
+61 (8) 8275 1297
Fax 40575 0
Email 40575 0
maayken.vandenberg@flinders.edu.au
Contact person for scientific queries
Name 40576 0
Dr Maayken van den Berg
Address 40576 0
Flinders University School of Medicine, Dep of Rehabilitation, Aged & Extended Care
Repatriation General Hospital
Daws Road
Daw Park, South Australia, 5041
Country 40576 0
Australia
Phone 40576 0
+61 (8) 8275 1297
Fax 40576 0
Email 40576 0
maayken.vandenberg@flinders.edu.au