Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000958886
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
6/09/2012
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Sitting Time AfteR Stroke (STARS). A phase II safety and feasibility trial of counselling sessions aimed at encouraging stroke survivors to 'move more and sit less'.
Scientific title
Can a series of counselling sessions aimed at encouraging people to 'move more and sit less' change the amount of time community-dwelling stroke survivors spend sitting each day, compared to a 'sham' intervention (counselling to optimise calcium intake).
Secondary ID [1] 281097 0
Nil
Universal Trial Number (UTN)
Trial acronym
STARS-f
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inactivity in community-dwelling stroke survivors. 287254 0
Condition category
Condition code
Stroke 287580 287580 0 0
Ischaemic
Stroke 287687 287687 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Information on the health effects of prolonged sitting. Detailed individual feedback on the individuals' patterns of sitting time and physical activity (from baseline assessement).
Series of 4 counselling sessions, based on Motivational Interviewing principles with the aim of encouraging participants to 'sit less and move more'. The first counselling session will occur at the beginning of week 2 of the trial, will be provided face-to-face and will last for approximately one hour. Subsequent sessions will be provided over the phone at the beginning of week 3, 5 and 9 and will last between 10 and 30 minutes.
Outcomes will be assessed by asking participants to wear activity monitors for one week at baseline (pre-intervention) and for one week at post-intervention (week 10)
Intervention code [1] 285549 0
Lifestyle
Intervention code [2] 285621 0
Behaviour
Comparator / control treatment
Information on the required levels of calcium for bone health. Individual feedback on calcium intake levels (from baseline dietary assessments).
Series of 4 counselling sessions, based on Motivational Interviewing principles with the aim of encouraging optimum calcium intake for bone health. The first counselling session will occur at the beginning of week 2 of the trial, will be provided face-to-face and will last for approximately one hour. Subsequent sessions will be provided over the phone at the beginning of week 3, 5 and 9 and will last between 10 and 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 287838 0
Participants will be questioned about any falls they had during the intervention period (number and details of falls - what they were doing at the time of the fall and injuries incurred).
Timepoint [1] 287838 0
End trial (post-intervention) at 10 weeks
Secondary outcome [1] 298909 0
The primary feasibility outcome is motivational interviewing (MI) fidelity (mean 95% of utterances per counseling sessions rated as MI consistent).
Timepoint [1] 298909 0
End trial (post-intervention) at week 10
Secondary outcome [2] 298910 0
Changes in self-reported fatigue (safety) using the Checklist Individual Strength - subscale fatigue (CIS-f).
Timepoint [2] 298910 0
End trial (post-intervention) at week 10
Secondary outcome [3] 298911 0
Other adverse events such as self-reported increases in pain, skin reactions to monitors (safety)
Timepoint [3] 298911 0
End trial (post-intervention) at week 10
Secondary outcome [4] 298912 0
Compliance with wearing activity monitors (feasibility) - number of valid wear days for each monitor for each participant
Timepoint [4] 298912 0
End trial (post-intervention) at week 10

Eligibility
Key inclusion criteria
Stroke survivors with last stroke occurring at least 6 months previously.
Living in the community for at least 2 months
Able to walk independently (with or without walking aid) around the house
Sufficient cognitive, language and hearing ability to participate in counseling sessions both face to face and over the phone.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other major co-morbidities significantly affecting mobility

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once they have completed the baseline assessment, the research assistant/trial investigator will phone a centralised randomisation service operated by a person independent to the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be stratified by site (SA and Vic) and walking speed (<0.4m/s, 0.4-0.8m/s and >0.8m/s). The sequence will be generated by a person independent of the trial by permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2012
Actual
15/01/2013
Date of last participant enrolment
Anticipated
Actual
1/02/2014
Date of last data collection
Anticipated
Actual
30/05/2014
Sample size
Target
40
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment postcode(s) [1] 6257 0
5000 - Adelaide
Recruitment postcode(s) [2] 6258 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 285882 0
Charities/Societies/Foundations
Name [1] 285882 0
National Stroke Foundation
Country [1] 285882 0
Australia
Primary sponsor type
University
Name
School of Health Sciences, University of South Australia
Address
North Terrace,
Adelaide, 5000
SA
Country
Australia
Secondary sponsor category [1] 284707 0
Other
Name [1] 284707 0
Stroke Division, Florey Neuroscience Institutes
Address [1] 284707 0
245 Burgandy St
Heidelberg 3085
Vic
Country [1] 284707 0
Australia
Other collaborator category [1] 277038 0
Individual
Name [1] 277038 0
Dr Genevieve Healy, School of Population Health, University of Queensland
Address [1] 277038 0
University of Queensland
Herston Rd
Herston Qld 4006
Country [1] 277038 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287911 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 287911 0
Ethics committee country [1] 287911 0
Australia
Date submitted for ethics approval [1] 287911 0
26/07/2012
Approval date [1] 287911 0
06/09/2012
Ethics approval number [1] 287911 0
0000030464

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

Contacts
Principal investigator
Name 34623 0
Dr Coralie English
Address 34623 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 34623 0
Australia
Phone 34623 0
+61 2 49138102
Fax 34623 0
+61 2 49217053
Email 34623 0
[email protected]
Contact person for public queries
Name 17870 0
Dr Coralie English
Address 17870 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 17870 0
Australia
Phone 17870 0
+61 2 49138102
Fax 17870 0
+61 2 49217053
Email 17870 0
[email protected]
Contact person for scientific queries
Name 8798 0
Dr Coralie English
Address 8798 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan
NSW 2308
Country 8798 0
Australia
Phone 8798 0
+61 2 49138102
Fax 8798 0
+61 2 49217053
Email 8798 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
SourceTitleYear of PublicationDOI
EmbaseReducing Sitting Time after Stroke: A Phase II Safety and Feasibility Randomized Controlled Trial Presented in part as a poster to the European Stroke Organization, April 17-19, 2015, Glasgow, United Kingdom; And Stroke 2015 (a combined conference of the Stroke Society of Australasia and Smartstrokes NSW), September 1-5, 2015, Melbourne, VIC, Australia.2016https://dx.doi.org/10.1016/j.apmr.2015.10.094
N.B. These documents automatically identified may not have been verified by the study sponsor.