- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02926313
The Effectiveness of Specialist Seating Provision for Nursing Home Residents
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Existing Seating conditions
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.
|
|
|
Eksperymentalny: Individualized Seating provision
This group of participants were provided with a seating system that was specifically configured to match their individual postural care needs.
|
Seating system selected and adjusted to meet individual needs.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in the Braden Scale
Ramy czasowe: Change in pressure injury risk from baseline at 12 weeks
|
Measures the risk of developing pressure injuries/ ulcers
|
Change in pressure injury risk from baseline at 12 weeks
|
|
Change in Oxygen saturation levels
Ramy czasowe: Change in SpO2 levels from baseline at 12 weeks
|
Pulse oximeter used to measure saturated oxygen levels
|
Change in SpO2 levels from baseline at 12 weeks
|
|
Seating assessment
Ramy czasowe: baseline
|
This measures the individual's level of sitting skills and abilities
|
baseline
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in sitting presentation - digitally captured
Ramy czasowe: Change in sitting presentation from baseline to 12 weeks
|
Visually record presentation of the resident in the seating system using digital photographs
|
Change in sitting presentation from baseline to 12 weeks
|
|
Change in Quality of life factors - questionnaire
Ramy czasowe: Change in quality of life from baseline to 12 weeks
|
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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 12/0084
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
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