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Trial registered on ANZCTR
Registration number
ACTRN12618001295235
Ethics application status
Approved
Date submitted
26/07/2018
Date registered
1/08/2018
Date last updated
6/02/2020
Date data sharing statement initially provided
6/02/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
comparing physical and social outcomes for immobile aged care residents when using a new design high support chair against immobile aged care residents using the traditional design high support chair study (H.S.C. study)
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Scientific title
Comparing the effect of high support chair design on physical decline and levels social engagement of immobile aged care residents
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Secondary ID [1]
295640
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
immobility
308980
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physical decline
309034
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decreased social engagement
309035
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Condition category
Condition code
Musculoskeletal
307875
307875
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0
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Other muscular and skeletal disorders
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Mental Health
307928
307928
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will be to offer an alternative chair design to participants when they have been assessed as immobile. The assessment for immobility will be performed by a Physiotherapist known to the participant. Once assessed as immobile the site Clinical Nurse liaise with the potential participant to discuss the study, as well as offer the Participant Information and Consent form(PICF). Once consent has been granted a random allocation of either the new design or traditional design high support chair will be performed.
The participant will be able to withdraw from the study at anytime, the chair allocated to them will not change. If the participant remains active in the study, they will use the high support chair allocated to them daily for the 12 month study duration. The use of the chair will be based on normative, individualised care for each participant. Most participants will use the chair for up to 9 hours per day, however daily usage times will vary depending on periods of ill health when additional rest may be required. All chair users are also periodically moved in and out of the chair throughout the day for attendance to personal hygiene.
All chairs will be in use at ACH Group residential facilities in South Australia. ( new design high support chair n=16; traditional design high support chair n=16)
The locations for interventions are:
ACH Group West Park, 7 Partridge St GOOLWA, S.A. 5214
ACH Group Yankalilla Centre, 175 Main South Rd, YANKALILLA, S.A. 5203
ACH Group Colton Court, 84 Valley View Drv McLAREN VALE, S.A. 5171
ACH Group Highercombe, 5-11 Sirius Ave, HOPE VALLEY, S.A. 5090
ACH Group Kapara, 80 Moseley St, GLENELG, S.A. 5045
ACH Group Milpara, 147 St Bernards Rd, ROSTREVOR, S.A. 5073
ACH Group Perry Park, 26 River Rd, PT NOARLUNGA, S.A. 5167
ACH Group ViTA, 17 Rockville Ave, DAW PARK ,S.A. 5041
The new design high support chair is vastly different from the traditional design high support chairs in the following ways:
1) Non-clinical in appearance - wheels and handles are completely concealed.
2) Limited recline - this is to hinder the physical decline to upper body muscles, and prevent the chair from being used as a restraint
3) Limited elevation on kick plate - this is to allow feet to touch the floor; minimising pressure area sore development and preventing contracture of the feet and ankles
4) Height adjustable - allows all users to be able to have their feet flat on the floor regardless of their height; minimising pressure area sore development and preventing contracture of the feet and ankles
5) Self propelling controls - the concealed controls allow staff to use the chair without any force; contribute to minimising manual handling injuries for staff
6) Arms of chair contoured - this feature will allow the chair to be comfortably wheeled up to a dining table, promoting social inclusion at meal times. The current style chair cannot fit at a dining table, which means that users of the traditional chair need to eat all of their meals separately.
Once the chair has been allocated to the older immobile person, the participant will not need to do anything but use the chair as a normative part of their care.
ACH Group provides 24 hour nursing care, all participants will be observed by staff each day. All staff will be trained prior to distribution and allocation of the new design chair. The training package includes design feature rationale, how to use the chairs, as well as education on the measures that will be recorded. All staff will be able to contact the study team at any time, as well as be visited by the study team at scheduled times throughout the 12 month study period.
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Intervention code [1]
301988
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Prevention
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Intervention code [2]
301993
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Treatment: Other
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Comparator / control treatment
The non-intervention group (n=16) will be assessed as immobile by a physiotherapist known to the participant. This control group will be offered the traditional style high support chair that is usual for people when assessed as immobile. The control group participants will able to withdraw from the study at anytime, the chair that has been allocated to them will not change. If the participant remains active in the study, they will be using the chair for 12 months. There are no specific guidelines regarding the use of a high support chair.
The new design high support chair is vastly different from the traditional design high support chairs in the following ways:
1) Non-clinical in appearance - wheels and handles are completely concealed.
2) Limited recline - this is to hinder the physical decline to upper body muscles, and prevent the chair from being used as a restraint
3) Limited elevation on kick plate - this is to allow feet to touch the floor; minimising pressure area sore development and preventing contracture of the feet and ankles
4) Height adjustable - allows all users to be able to have their feet flat on the floor regardless of their height; minimising pressure area sore development and preventing contracture of the feet and ankles
5) Self propelling controls - the concealed controls allow staff to use the chair without any force; contribute to minimising manual handling injuries for staff
6) Arms of chair contoured - this feature will allow the chair to be comfortably wheeled up to a dining table, promoting social inclusion at meal times. The current style chair cannot fit at a dining table, which means that users of the traditional chair need to eat all of their meals separately.
Once the chair has been allocated to the older immobile person, the participant will not need to do anything but use the chair as a normative part of their care.
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Control group
Active
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Outcomes
Primary outcome [1]
306893
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changes to Weight. measure is taken using a weigh chair and recorded in participant care plans as a normative part of care
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Assessment method [1]
306893
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Timepoint [1]
306893
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12 months
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Primary outcome [2]
306936
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changes to pain management regime.
Identification to a need for changes to main management are assessed using a pain chart. any changes made are recorded in both the medication chart and the care plan. If there have been no changes, this will be recorded as such in the data collected
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Assessment method [2]
306936
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Timepoint [2]
306936
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12 months
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Primary outcome [3]
306937
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Physiotherapist report.
A physiotherapy assessment is performed as part of normative care every 6 months for all aged care residents. Progress is recorded in the physiotherapy assessment part of the care plan. If a participant requires additional attention from a physiotherapist at anytime outside of the usual 6 monthly assessment this information will be captured in the physiotherapy assessment within the care plan. If there have been no changes, this will be recorded as such in the data collected
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Assessment method [3]
306937
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Timepoint [3]
306937
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12 months
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Secondary outcome [1]
350044
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changes social engagement (Primary outcome).All social engagement is captured using a daily lifestyle checklist
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Assessment method [1]
350044
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Timepoint [1]
350044
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12 months.
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Secondary outcome [2]
350155
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changes to swallowing ability as assessed by a Speech Pathologist (primary outcome)
A speech pathology assessment is performed as part of normative care on admission for all aged care residents. If changes in swallowing ability are observed by staff a further assessment by a Speech Pathologist will be requested. Progress is recorded in the Speech Pathology assessment part of the care plan. If there have been no changes, this will be recorded as such in the data collected
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Assessment method [2]
350155
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Timepoint [2]
350155
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12 months
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Secondary outcome [3]
350156
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reports of the need for pressure area care (Primary Outcome)
As a normal part of 24 hour care, all participants will have the skin observed for changes. If the development of a pressure area sore is reported the Physiotherapist will initiate a regime for management. This information will be recorded in the Physiotherapy assessment. If there have been no changes, this will be recorded as such in the data collected
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Assessment method [3]
350156
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Timepoint [3]
350156
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12 months
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Eligibility
Key inclusion criteria
assessed as immobile within 7 days of being offered the high support chair alternative
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
mobile aged care residents
aged care residents who have been assessed as immobile for a period greater than 7 days
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
number of participants is based on funding. The high support chair alternatives cost in in excess of $6,000 each. Internal ACH Group funding (which included prototyping, testing to Australian Standards &, Patent application) allowed for the manufacture of 16 chairs.
We aim to compare physical and social changes for immobile aged care residents using the new design high support chair against immobile aged care residents that use the traditional style high support chair
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/11/2018
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Actual
20/12/2019
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Date of last participant enrolment
Anticipated
30/06/2020
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Actual
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Date of last data collection
Anticipated
30/06/2021
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Actual
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Sample size
Target
32
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Accrual to date
2
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
11542
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ACH Group Residential - West Park - Goolwa
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Recruitment hospital [2]
11543
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ACH Group Residential - Colton Court - Mclaren Vale
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Recruitment hospital [3]
11544
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ACH Group Residential - Yankalilla Centre - Yankalilla
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Recruitment hospital [4]
11545
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ACH Group Residential - Highercombe - Hope Valley
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Recruitment hospital [5]
11546
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ACH Group Residential - Kapara - Glenelg South
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Recruitment hospital [6]
11547
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ACH Group Residential - Milpara - Rostrevor
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Recruitment hospital [7]
11548
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ACH Group Residential - Perry Park - Port Noarlunga
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Recruitment hospital [8]
11549
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ACH Group ViTA - Daw Park
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Recruitment postcode(s) [1]
23570
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5214 - Goolwa
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Recruitment postcode(s) [2]
23571
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5171 - Mclaren Vale
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Recruitment postcode(s) [3]
23572
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5203 - Yankalilla
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Recruitment postcode(s) [4]
23573
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5090 - Hope Valley
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Recruitment postcode(s) [5]
23574
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5045 - Glenelg South
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Recruitment postcode(s) [6]
23575
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5073 - Rostrevor
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Recruitment postcode(s) [7]
23576
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5167 - Port Noarlunga
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Recruitment postcode(s) [8]
23577
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5041 - Daw Park
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Funding & Sponsors
Funding source category [1]
300222
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Commercial sector/Industry
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Name [1]
300222
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ACH Group
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Address [1]
300222
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22 Henley Beach Rd
MILE END South Australia, 5031
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Country [1]
300222
0
Australia
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Primary sponsor type
Commercial sector/Industry
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Name
ACH Group
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Address
22 Henley Beach Rd
MILE END South Australia, 5031
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Country
Australia
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Secondary sponsor category [1]
299631
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None
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Name [1]
299631
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Address [1]
299631
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Country [1]
299631
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301044
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
301044
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Ward 6C / Room 6A 219, Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
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Ethics committee country [1]
301044
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Australia
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Date submitted for ethics approval [1]
301044
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03/08/2018
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Approval date [1]
301044
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15/02/2019
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Ethics approval number [1]
301044
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Summary
Brief summary
When people in residential aged care facilities become immobile a high support chair (HSC) is used to maintain health advantages related to upright posture and continued social participation rather than staying in bed. Unintended negative outcomes however are occurring due to poor posture related to current HSC design. These include difficulties swallowing, contractures, pressure areas and discomfort. As well current HSC are difficult to manoeuvre and have resulted in injuries to care staff. Aged Care Housing (ACH) Group have designed a new HSC with features designed to overcome these limitations. This research will investigate if the new HSC does improve physical and social outcomes for immobile people and prevent injuries in the staff who care for them.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
85690
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Prof Sue Gordon
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Address
85690
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Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
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Country
85690
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Australia
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Phone
85690
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+61 407785699
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Fax
85690
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Email
85690
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[email protected]
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Contact person for public queries
Name
85691
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Prof Sue Gordon
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Address
85691
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Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
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Country
85691
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Australia
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Phone
85691
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+61 407785699
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Fax
85691
0
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Email
85691
0
[email protected]
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Contact person for scientific queries
Name
85692
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Prof Sue Gordon
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Address
85692
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Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
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Country
85692
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Australia
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Phone
85692
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+61 407785699
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Fax
85692
0
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Email
85692
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
6804
Ethical approval
375658-(Uploaded-31-01-2020-09-59-00)-Study-related document.pdf
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.
Download to PDF