- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02926313
The Effectiveness of Specialist Seating Provision for Nursing Home Residents
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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.
|
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the Braden Scale
Délai: 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
Délai: 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
Délai: baseline
|
This measures the individual's level of sitting skills and abilities
|
baseline
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in sitting presentation - digitally captured
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 12/0084
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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