- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02926313
The Effectiveness of Specialist Seating Provision for Nursing Home Residents
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: 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.
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in the Braden Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline
|
This measures the individual's level of sitting skills and abilities
|
baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in sitting presentation - digitally captured
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 12/0084
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Fysisk handicap
-
Assistance Publique - Hôpitaux de ParisPlateforme PRISMEAfsluttet
-
Affiliated Hospital to Academy of Military Medical...Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Peking...RekrutteringAldersinterval ≥16 år, køn ubegrænset | Histopatologi bekræftet diffust stort B-celle lymfom eller højgradigt B-celle lymfom | Modtaget tidligere førstelinjekemoterapi for DLBCL eller HGBL, kunne ikke nå CR i fire cyklusser eller tilbagefald | Mindst én positiv læsion ifølge 2014 Lugano-kriterierne... og andre forholdKina
-
Simons SearchlightBoston Children's Hospital; Geisinger Clinic; Simons FoundationRekrutteringSMARCA4 genmutation | DDX3X | 16P11.2 Deletionssyndrom | 16p11.2 Duplikationer | 1Q21.1 Sletning | 1Q21.1 mikroduplikationssyndrom (lidelse) | ACTL6B | ADNP | AHDC1 | ANK2 | ANKRD11 | ARID1B | ASH1L | BCL11A | CHAMP1 | CHD2 | CHD8 | CSNK2A1 | CTBP1 | CTNNB1-genmutation | CUL3 | DNMT3A | DSCAM | DYRK1A | FOXP1 | GRIN2A | GRIN2B | HIVEP2-relateret intellektuel... og andre forholdForenede Stater
-
Sanford HealthNational Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins... og andre samarbejdspartnereRekrutteringMitokondrielle sygdomme | Retinitis Pigmentosa | Myasthenia gravis | Eosinofil gastroenteritis | Multipel systematrofi | Leiomyosarkom | Leukodystrofi | Anal fistel | Spinocerebellar ataksi type 3 | Friedreich Ataxia | Kennedys sygdom | Lyme sygdom | Hæmofagocytisk lymfohistiocytose | Spinocerebellar ataksi type 1 | Spinocerebellar... og andre forholdForenede Stater, Australien
Kliniske forsøg med Individualized Seating provision
-
Wake Forest University Health SciencesPermobil, Inc.AfsluttetAmyotrofisk lateral skleroseForenede Stater
-
Centre Hospitalier Universitaire de NīmesUniversity Hospital, Montpellier; Hospital Center, Alès; CH Bagnols sur Cèze og andre samarbejdspartnereRekruttering
-
Eunice Kennedy Shriver National Institute of Child...Ukendt
-
The Hong Kong Polytechnic UniversityRekrutteringSarkopenisk fedmeHong Kong
-
US Department of Veterans AffairsAfsluttetSiddende Løbebåndstræning | Løbebånd Locomotor-baseret træning | Kun løbebåndForenede Stater
-
Duke UniversityNational Heart, Lung, and Blood Institute (NHLBI); RTI InternationalAfsluttetHæmatologiske sygdomme | Seglcellesygdom | Anæmi, seglcelle | Genetisk sygdomForenede Stater