Physical DisabilityNCT02926313
The Effectiveness of Specialist Seating Provision for Nursing Home Residents
A study testing Individualized Seating provision in people with Physical Disability, run by University of Ulster.
Trial summary
A randomized control study aimed to investigate if suitable individualized seating provision is effective for adult nursing home residents in reducing the incidence of pressure ulcers, and increasing their quality of life and functioning. Read more about this study
- Who is it for?
- Ages 44 to 98 years
- Conditions the study is for
- Physical Disability
- What is being tested?
- Individualized Seating provision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult living in one of the three nursing home facilities
Who cannot join
- Determined to be at a high risk of developing pressure ulcers (as per Braden Scale assessment)
About this study
A randomized control study aimed to investigate if suitable individualized seating provision is effective for adult nursing home residents in reducing the incidence of pressure ulcers, and increasing their quality of life and functioning.
Read the detailed description
The United Kingdom (UK) population demographics confirm that older people are considered to be the fastest-growing group in the population (Dunnell, 2008). In 2007, 9.8 million people were aged over 65; however, by 2032 this figure is projected to rise to 16.1 million (Dunnell, 2008). Many of these older adults will have complex health and social care needs sometimes requiring nursing home care. A high standard and quality of care within our nursing homes is essential, to be able to deal with this growing population safely and to the highest standard possible, including the provision of individualised seating assessment, prescription and provision. An individually prescribed seating system should be based upon the assessment of the person's abilities and needs, and should best position and support them for comfort and function.
When seating is not clinically suitable for the user there are many physiological and psychological implications for the user. For example, often pressure ulcers may develop. Pressure ulcers are currently a major concern for the NHS due to their prevalence, the cost of treatments and the impact on the person. Pressure ulcers can often be related to poor seating and indeed good seating can contribute to prevention and contribute to healing (Anton, 2005). Current expenditure by the NHS in the UK on pressure sores is £2.1bn annually. This equates to approximately £10,500 per sore (Bennett et al, 2004). Anecdotal evidence suggests that correct seating provision could be instrumental in depleting this cost by preventing pressure ulcers through investment in chairs before ulcers develop. This project set out to explore this topic via empirical research methods.
Research Question To identify the importance of individualised seating in reducing postural difficulties for adult residents in nursing homes.
Methods A pragmatic RCT design with qualitative and quantitative tools was used. These included: pulse oximeter readings of oxygen saturation levels and pulse rate; Braden scale of pressure risk; caregiver questionnaire; digital photographs of seated posture; and demographic information.
Participants Forty residents were recruited from three nursing homes in N.Ireland, and were randomly assigned to either the control group (continue to use existing chair) or the intervention group (use an individually configured seating system) for the 12- week trial period. At the end of the 12- week trial period there were 18 participants in each group.
- Conditions
- Physical Disability
- Being tested
- Individualized Seating provision
- Keywords
- RCT, Specialized seating, Pressure ulcers
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Seating provisionOther
Seating system selected and adjusted to meet individual needs.
| Study group | Role | What they receive |
|---|---|---|
| Existing Seating conditions | No intervention | This group of participants received the standard care - they continue to sit in the seating system (chair and cushion) as provided by the nursing home facility staff; selected from whatever seats the facility had available. |
| Individualized Seating provision | Experimental | This group of participants were provided with a seating system that was specifically configured to match their individual postural care needs. Receives: Other: Individualized Seating provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Braden Scale
Measures the risk of developing pressure injuries/ ulcers
Measured: Change in pressure injury risk from baseline at 12 weeks
Change in Oxygen saturation levels
Pulse oximeter used to measure saturated oxygen levels
Measured: Change in SpO2 levels from baseline at 12 weeks
Seating assessment
This measures the individual's level of sitting skills and abilities
Measured: baseline
Secondary outcomes (2)
Change in sitting presentation - digitally captured
Visually record presentation of the resident in the seating system using digital photographs
Measured: Change in sitting presentation from baseline to 12 weeks
Change in Quality of life factors - questionnaire
This questionnaire gathered perspective on changes; for example, how many times the resident needs to be moved and handled, repositioned int heir chair, whether they can feed themselves, call out to others and presence of any skin redness or skin breakdown
Measured: Change in quality of life from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Seating Matters Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926313
- Sponsor's protocol ID
- 12/0084
- Status last verified
- Oct 2016
- First submitted
- 3 Oct 2016
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Specialist Seating Provision for Nursing Home Residents
- ClinicalTrials.gov ID
- NCT02926313
- Acronym / sponsor ID
- 12/0084
- Conditions
- Physical Disability
- Keywords
- RCT, Specialized seating, Pressure ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Seating Matters Ltd.
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control study aimed to investigate if suitable individualized seating provision is effective for adult nursing home residents in reducing the incidence of pressure ulcers, and increasing their quality of life and functioning.
Detailed description
The United Kingdom (UK) population demographics confirm that older people are considered to be the fastest-growing group in the population (Dunnell, 2008). In 2007, 9.8 million people were aged over 65; however, by 2032 this figure is projected to rise to 16.1 million (Dunnell, 2008). Many of these older adults will have complex health and social care needs sometimes requiring nursing home care. A high standard and quality of care within our nursing homes is essential, to be able to deal with this growing population safely and to the highest standard possible, including the provision of individualised seating assessment, prescription and provision. An individually prescribed seating system should be based upon the assessment of the person's abilities and needs, and should best position and support them for comfort and function.
When seating is not clinically suitable for the user there are many physiological and psychological implications for the user. For example, often pressure ulcers may develop. Pressure ulcers are currently a major concern for the NHS due to their prevalence, the cost of treatments and the impact on the person. Pressure ulcers can often be related to poor seating and indeed good seating can contribute to prevention and contribute to healing (Anton, 2005). Current expenditure by the NHS in the UK on pressure sores is £2.1bn annually. This equates to approximately £10,500 per sore (Bennett et al, 2004). Anecdotal evidence suggests that correct seating provision could be instrumental in depleting this cost by preventing pressure ulcers through investment in chairs before ulcers develop. This project set out to explore this topic via empirical research methods.
Research Question To identify the importance of individualised seating in reducing postural difficulties for adult residents in nursing homes.
Methods A pragmatic RCT design with qualitative and quantitative tools was used. These included: pulse oximeter readings of oxygen saturation levels and pulse rate; Braden scale of pressure risk; caregiver questionnaire; digital photographs of seated posture; and demographic information.
Participants Forty residents were recruited from three nursing homes in N.Ireland, and were randomly assigned to either the control group (continue to use existing chair) or the intervention group (use an individually configured seating system) for the 12- week trial period. At the end of the 12- week trial period there were 18 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Existing Seating conditions | No intervention | –This group of participants received the standard care - they continue to sit in the seating system (chair and cushion) as provided by the nursing home facility staff; selected from whatever seats the facility had available. |
| Individualized Seating provision | Experimental | Other: Individualized Seating provisionThis group of participants were provided with a seating system that was specifically configured to match their individual postural care needs. |
Who may qualify
- Ages
- 44 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult living in one of the three nursing home facilities
Key exclusion criteria (1 listed)
- Determined to be at a high risk of developing pressure ulcers (as per Braden Scale assessment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Seating provisionSeating system selected and adjusted to meet individual needs. | Other | Individualized Seating provision |
Primary outcome
Change in the Braden Scale
Time frame: Change in pressure injury risk from baseline at 12 weeks
Measures the risk of developing pressure injuries/ ulcers
Change in Oxygen saturation levels
Time frame: Change in SpO2 levels from baseline at 12 weeks
Pulse oximeter used to measure saturated oxygen levels
Seating assessment
Time frame: baseline
This measures the individual's level of sitting skills and abilities
2 secondary outcomes
Change in sitting presentation - digitally captured
Time frame: Change in sitting presentation from baseline to 12 weeks
Change in Quality of life factors - questionnaire
Time frame: Change in quality of life from baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Seating provision in people with Physical Disability, run by University of Ulster.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Braden Scale (time frame: Change in pressure injury risk from baseline at 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.