Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000708954
Ethics application status
Approved
Date submitted
18/05/2020
Date registered
29/06/2020
Date last updated
29/06/2020
Date data sharing statement initially provided
29/06/2020
Date results provided
29/06/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Carers' Count study ; an evaluation of the implementation of an exercise group for inpatient stroke survivors and their carers
Scientific title
The Carers' Count study ; an evaluation of the implementation of an exercise group for inpatient stroke survivors and their carers
Secondary ID [1] 301321 0
Nil known
Universal Trial Number (UTN)
U1111-1252-2093
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 317519 0
Condition category
Condition code
Neurological 315614 315614 0 0
Other neurological disorders
Stroke 315615 315615 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 315616 315616 0 0
Other physical medicine / rehabilitation
Stroke 315617 315617 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stroke survivors and their carers participated in an exercise program, Carers' Count, whilst on the inpatient stroke ward. The group was conducted 3 times per week from 4-5pm and up to 6 stroke survivors attended at one time. The group involved music therapy and exercises, conducted as a group and facilitated by a physiotherapist. Additionally participants would play games and practice functional activities such as sit to stand practice , with their carer facilitating. There was an emphasis on discussing neuroplasticity and how the recovery can be optimised through practice outside of therapy times. In one session each week the music therapist attended and played the guitar and sang songs. On the other sessions the attendees could choose favourite songs from a playlist. The participants performed some basic exercises as a group such as squats, seating arm and leg exercises with theraband and weights and sit to stand practice. Each participant also had an individual exercise program which was written by their treating therapist - at time during the group the carers facilitated these individual exercise programs. The patient was able to participate in the group until discharged form hospital.
Intervention code [1] 317619 0
Rehabilitation
Intervention code [2] 317807 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323852 0
Stroke survivor satisfaction
Timepoint [1] 323852 0
Survey in first week of participation (designed by the researcher)
Interview one moth post-discharge
Primary outcome [2] 323957 0
Carer satisfaction
Timepoint [2] 323957 0
survey after one week of participation (designed by the researcher), interview one month following discharge
Secondary outcome [1] 383050 0
dosage of therapy
Timepoint [1] 383050 0
at completion of study, calculation of mean therapy times on group days and non-group days (via electronic medical records)
Secondary outcome [2] 383435 0
staff satisfaction
Timepoint [2] 383435 0
Focus group 2 months after study commenced. Qualitative analysis of transcripts to produce themes

Eligibility
Key inclusion criteria
Diagnosed with stroke
Carer available to attend
Appropriate to participate in a group (determined by treating therapist)
Anticipated length of stay >10 days
English speaking (or have a carer to translate)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carer not available to attend
Inappropriate to participate in a group (determined by treating therapist)
Anticipated length of stay <10 days
Non-english speaking (or no a carer to translate)

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Qualitative analysis- interviews and focus group
Calculation of means of therapy dosage time

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/10/2019
Date of last participant enrolment
Anticipated
Actual
4/03/2020
Date of last data collection
Anticipated
Actual
10/04/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 16705 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30304 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 305758 0
Hospital
Name [1] 305758 0
Flinders Medical Centre
Country [1] 305758 0
Australia
Primary sponsor type
Individual
Name
Tamina Levy
Address
Flinders Medical Centre - Rehabilitation and Palliative Services
Flinders Drive, Bedford Park,
South Australia 5042
Country
Australia
Secondary sponsor category [1] 306193 0
None
Name [1] 306193 0
Address [1] 306193 0
Country [1] 306193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306030 0
The Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC EC00188).
Ethics committee address [1] 306030 0
Ethics committee country [1] 306030 0
Australia
Date submitted for ethics approval [1] 306030 0
06/01/2019
Approval date [1] 306030 0
16/07/2019
Ethics approval number [1] 306030 0
HREC/19/SAC/83

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

Contacts
Principal investigator
Name 102482 0
A/Prof Kate Laver
Address 102482 0
Flinders University
Sturt Road
Bedford Park 5042
South Australia
Country 102482 0
Australia
Phone 102482 0
+61 0882751103
Fax 102482 0
Email 102482 0
[email protected]
Contact person for public queries
Name 102483 0
Tamina Levy
Address 102483 0
Flinders Medical Centre - Rehabilitation Services
Flinders Drive
Bedford Park
SA 5042
Country 102483 0
Australia
Phone 102483 0
+61409282210
Fax 102483 0
Email 102483 0
[email protected]
Contact person for scientific queries
Name 102484 0
Tamina Levy
Address 102484 0
Flinders Medical Centre - Rehabilitation Services
Flinders Drive
Bedford Park
SA 5042
Country 102484 0
Australia
Phone 102484 0
+61409282210
Fax 102484 0
Email 102484 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.