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Trial registered on ANZCTR


Registration number
ACTRN12614000186651
Ethics application status
Approved
Date submitted
13/02/2014
Date registered
20/02/2014
Date last updated
9/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial investigating the convenience and practicality of utilising a floor-based dome device by healthy 18 to 75 year old subjects whilst in their usual working environment
Scientific title
Open label trial investigating the convenience and practicality of utilising a floor-based dome device by healthy 18 to 75 year old subjects whilst undertaking a sedentary job in their usual working environment
Secondary ID [1] 284088 0
None
Universal Trial Number (UTN)
U1111-1153-3011
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 291160 0
Condition category
Condition code
Blood 291494 291494 0 0
Clotting disorders
Cardiovascular 291495 291495 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Floor-based footrest.
This is a small device, approximately 300mm in length, with two raised domes. Viewed from the front it looks like a letter m. Users will flex and extend the soles of their feet over the humps. This is expected to improve blood flow from the legs back to the heart even while the users are seated.

After informed consent, the volunteers will each be given a floor-based dome device and shown how to use it throughout the working week. Participants in this study will be asked to utilise the device for a minimum of 30 to 60 seconds every hour regardless of how long they may have been sitting down or how much they may have been walking in the office throughout the day.

Participants will be given a diary in which to document their device usage (time of day it was used, duration of use and whether they had shoes on or off) each day. At the end of the week they will also be asked to rate how convenient they found the device, how easy and comfortable it was to use and how likely they would be to use it regularly throughout their working days in the future. These rating will be measured on a scale of 1 (very convenient / easy / comfortable / likely to use it again) to 4 (very inconvenient / very hard / very comfortable / definitely not likely to use it again). They will be asked to note down any adverse events associated with the device in the workplace. A free text space will be provided to note down any other thoughts or concerns about the device.
Intervention code [1] 288783 0
Prevention
Comparator / control treatment
There is no comparator / control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291471 0
Mean number of times the device is used in a working day.

Mean calculated by taking documented diary notes as made by the participants during the study
Timepoint [1] 291471 0
5 days
Secondary outcome [1] 306846 0
Qualitative feedback on the acceptability of the device and likelihood of its continued use in a sedentary workplace environment.
This will be established by reveiwing the questionnaire filled in at the end of the study by the participants
These ratings will be measured on a scale of 1 (very convenient / easy / comfortable / likely to use it again) to 4 (very inconvenient / very hard / very comfortable / definitely not likely to use it again). A free text space will be provided to note down any other thoughts or concerns about the device.
Timepoint [1] 306846 0
At 5 days

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide informed consent
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give informed consent
Inability to abide by the requirements of the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The proportion of participants who use the device at least 4 times per day (50% adherence) will be estimated by the exact binomial method with 95% confidence intervals.

Mean times usage per day and maximum and minimum times used per day will be calculated to allow comparison between each day of intervention.

Ordinal scale variables will be dichotomised into positive (e.g. very comfortable + comfortable) versus negative (e.g. uncomfortable and very uncomfortable). McNemar’s test for paired proportions will be applied, and appropriate estimates and confidence intervals will be developed for the discordant proportions.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
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] 5821 0
New Zealand
State/province [1] 5821 0
Wellington

Funding & Sponsors
Funding source category [1] 288718 0
Charities/Societies/Foundations
Name [1] 288718 0
Medical Research Institute of New Zealand
Address [1] 288718 0
Level 7, CSB Building
Wellington Regional Hospital
Riddiford Street
Newtown
Wellington 6021
Country [1] 288718 0
New Zealand
Primary sponsor type
University
Name
Victoria University of Wellington
Address
School of Biological Sciences
Victoria University of Wellington
PO Box 600
Wellington 6140
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287420 0
None
Name [1] 287420 0
Address [1] 287420 0
Country [1] 287420 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290557 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 290557 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington
Ethics committee country [1] 290557 0
New Zealand
Date submitted for ethics approval [1] 290557 0
07/01/2015
Approval date [1] 290557 0
27/01/2015
Ethics approval number [1] 290557 0
15/STH/6

Summary
Brief summary
We want to see whether it is convenient and practical for office-based workers to use the dome device regularly throughout the working day to improve blood flow through their legs while they are sitting down. We know that people sitting down for long periods of time (like when they are flying long distances, or in desk-bound role), may be at increased risk of developing blood clots called deep vein thrombosis (DVT) in their legs. This risk might be partly due to pooling of blood in the leg during long periods of sitting. Using the dome device every so often may help reduce pooling by improving the return of blood from the legs when used.

To see if it’s practical to use the dome device in the workplace we would like to run a trial of approximately 200 office and call centre-based people using the device over the course of their working week.

If we can show that the dome device is convenient, safe and practical, we may be able to introduce it as a simple office tool for people to help reduce the risk of developing blood clots when they are sitting down for long periods of time.
Trial website
Trial related presentations / publications
The manuscript relating to this study has been submitted to, and accepted for Publication by the Journal of Health Safety and Environment.
Public notes

Contacts
Principal investigator
Name 36482 0
Dr Irene Braithwaite
Address 36482 0
Medical Research institute of New Zealand,
Private Bag 7902,
Wellington 6242
Country 36482 0
New Zealand
Phone 36482 0
+64 4 805 0245
Fax 36482 0
Email 36482 0
irene.braithwaite@mrinz.ac.nz
Contact person for public queries
Name 36483 0
Dr Irene Braithwaite
Address 36483 0
Medical Research institute of New Zealand,
Private Bag 7902,
Wellington 6242
Country 36483 0
New Zealand
Phone 36483 0
+64 4 805 0245
Fax 36483 0
Email 36483 0
irene.braithwaite@mrinz.ac.nz
Contact person for scientific queries
Name 36484 0
Dr Irene Braithwaite
Address 36484 0
Medical Research institute of New Zealand,
Private Bag 7902,
Wellington 6242
Country 36484 0
New Zealand
Phone 36484 0
+64 4 805 0245
Fax 36484 0
Email 36484 0
irene.braithwaite@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary