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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02926313
Other study ID # 12/0084
Secondary ID
Status Completed
Phase N/A
First received October 3, 2016
Last updated October 5, 2016
Start date October 2012
Est. completion date August 2013

Study information

Verified date October 2016
Source University of Ulster
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Institute for Health Research
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date August 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 44 Years to 98 Years
Eligibility Inclusion Criteria:

- Adult living in one of the three nursing home facilities

Exclusion Criteria:

- Determined to be at a high risk of developing pressure ulcers (as per Braden Scale assessment)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Individualized Seating provision
Seating system selected and adjusted to meet individual needs.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Ulster Seating Matters Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the Braden Scale Measures the risk of developing pressure injuries/ ulcers Change in pressure injury risk from baseline at 12 weeks No
Primary Change in Oxygen saturation levels Pulse oximeter used to measure saturated oxygen levels Change in SpO2 levels from baseline at 12 weeks No
Primary Seating assessment This measures the individual's level of sitting skills and abilities baseline No
Secondary Change in sitting presentation - digitally captured Visually record presentation of the resident in the seating system using digital photographs Change in sitting presentation from baseline to 12 weeks No
Secondary 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 Change in quality of life from baseline to 12 weeks No
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