Trial Review

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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)
Scientific title
Comparing the effect of high support chair design on physical decline and levels social engagement of immobile aged care residents
Secondary ID [1] 295640 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immobility 308980 0
physical decline 309034 0
decreased social engagement 309035 0
Condition category
Condition code
Musculoskeletal 307875 307875 0 0
Other muscular and skeletal disorders
Mental Health 307928 307928 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 301988 0
Prevention
Intervention code [2] 301993 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 306893 0
changes to Weight. measure is taken using a weigh chair and recorded in participant care plans as a normative part of care



Timepoint [1] 306893 0
12 months
Primary outcome [2] 306936 0
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
Timepoint [2] 306936 0
12 months
Primary outcome [3] 306937 0
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
Timepoint [3] 306937 0
12 months
Secondary outcome [1] 350044 0
changes social engagement (Primary outcome).All social engagement is captured using a daily lifestyle checklist
Timepoint [1] 350044 0
12 months.
Secondary outcome [2] 350155 0
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
Timepoint [2] 350155 0
12 months
Secondary outcome [3] 350156 0
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
Timepoint [3] 350156 0
12 months

Eligibility
Key inclusion criteria
assessed as immobile within 7 days of being offered the high support chair alternative
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
mobile aged care residents
aged care residents who have been assessed as immobile for a period greater than 7 days

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



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2018
Actual
20/12/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
30/06/2021
Actual
Sample size
Target
32
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11542 0
ACH Group Residential - West Park - Goolwa
Recruitment hospital [2] 11543 0
ACH Group Residential - Colton Court - Mclaren Vale
Recruitment hospital [3] 11544 0
ACH Group Residential - Yankalilla Centre - Yankalilla
Recruitment hospital [4] 11545 0
ACH Group Residential - Highercombe - Hope Valley
Recruitment hospital [5] 11546 0
ACH Group Residential - Kapara - Glenelg South
Recruitment hospital [6] 11547 0
ACH Group Residential - Milpara - Rostrevor
Recruitment hospital [7] 11548 0
ACH Group Residential - Perry Park - Port Noarlunga
Recruitment hospital [8] 11549 0
ACH Group ViTA - Daw Park
Recruitment postcode(s) [1] 23577 0
5041 - Daw Park
Recruitment postcode(s) [2] 23574 0
5045 - Glenelg South
Recruitment postcode(s) [3] 23575 0
5073 - Rostrevor
Recruitment postcode(s) [4] 23573 0
5090 - Hope Valley
Recruitment postcode(s) [5] 23576 0
5167 - Port Noarlunga
Recruitment postcode(s) [6] 23571 0
5171 - Mclaren Vale
Recruitment postcode(s) [7] 23572 0
5203 - Yankalilla
Recruitment postcode(s) [8] 23570 0
5214 - Goolwa

Funding & Sponsors
Funding source category [1] 300222 0
Commercial sector/Industry
Name [1] 300222 0
ACH Group
Country [1] 300222 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ACH Group
Address
22 Henley Beach Rd
MILE END South Australia, 5031
Country
Australia
Secondary sponsor category [1] 299631 0
None
Name [1] 299631 0
Address [1] 299631 0
Country [1] 299631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301044 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 301044 0
Ward 6C / Room 6A 219, Flinders Medical Centre
Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 301044 0
Australia
Date submitted for ethics approval [1] 301044 0
03/08/2018
Approval date [1] 301044 0
15/02/2019
Ethics approval number [1] 301044 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85690 0
Prof Sue Gordon
Address 85690 0
Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
Country 85690 0
Australia
Phone 85690 0
+61 407785699
Fax 85690 0
Email 85690 0
sue.gordon@flinders.edu.au
Contact person for public queries
Name 85691 0
Prof Sue Gordon
Address 85691 0
Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
Country 85691 0
Australia
Phone 85691 0
+61 407785699
Fax 85691 0
Email 85691 0
sue.gordon@flinders.edu.au
Contact person for scientific queries
Name 85692 0
Prof Sue Gordon
Address 85692 0
Flinders University
Level 2, 17 Rockville Avenue,
Daw Park SA 5041
Country 85692 0
Australia
Phone 85692 0
+61 407785699
Fax 85692 0
Email 85692 0
sue.gordon@flinders.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6804Ethical 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.