Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial.
Dementia
Europe
Hearing
Psychosocial intervention
Quality of life
Sensory intervention
Vision
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
25 Jan 2019
25 Jan 2019
Historique:
received:
29
06
2018
accepted:
09
10
2018
entrez:
27
1
2019
pubmed:
27
1
2019
medline:
29
5
2019
Statut:
epublish
Résumé
Hearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions. This is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness. This is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment. ISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Hearing and vision impairments are highly prevalent in people with dementia and may have a negative impact on quality of life and other dementia-related outcomes. Intervening to optimise sensory impairment and support sensory function may be a means of improving dementia-related outcomes. The SENSE-Cog trial will test whether a home-based multi-part sensory intervention is effective in improving quality of life and other key outcomes in people with dementia and hearing or vision problems (or both) and their companions.
METHODS
METHODS
This is an European, multi-centre, observer-blind, pragmatic, randomised controlled trial. Three hundred fifty four people with dementia and hearing or vision impairment (or both) and their companions will be randomly assigned to receive either "care as usual" or a multi-component sensory intervention including assessment and correction of hearing or vision impairments (or both), home-based (maximum 10 visits over 18 weeks), therapist-delivered sensory support (that is, adherence to devices; improving the sensory environment (that is, lighting), communication training, and sign-posting to other support agencies). Change from baseline to intervention end (18 weeks) and post-intervention (36 weeks) will be compared between the two arms in the following outcomes: quality of life (primary endpoint), sensory and cognitive functional ability, relationships, mental well-being, health resource utilisation and cost-effectiveness.
DISCUSSION
CONCLUSIONS
This is one of two articles outlining the SENSE-Cog trial. Here, we describe the protocol for the effectiveness of the SENSE-Cog intervention. A parallel and complementary process evaluation will be described elsewhere. If the SENSE-Cog trial demonstrates that the sensory intervention improves outcomes in dementia, we will make a toolkit of training materials, resources and information available to health and social care providers to implement the intervention in routine practice. This will be a significant contribution to the therapeutic management of people with dementia and sensory impairment.
TRIAL REGISTRATION
BACKGROUND
ISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.
Identifiants
pubmed: 30683150
doi: 10.1186/s13063-018-2973-0
pii: 10.1186/s13063-018-2973-0
pmc: PMC6347775
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
80Subventions
Organisme : Horizon 2020
ID : 668648
Investigateurs
Harvey Abrams
(H)
Nathalie Chaghil-Boissière
(N)
Pavlina Charalambous
(P)
Fidéline Collin
(F)
Fofi Constantinidou
(F)
Eric Frison
(E)
Camille Gilbert
(C)
Mark Hann
(M)
Catherine Helmer
(C)
Emma Hooper
(E)
Francine Jury
(F)
Evangelia Kontogianni
(E)
Brian Lawlor
(B)
Iracema Leroi
(I)
Charly Matard
(C)
Susana Montecelo
(S)
Sarah Marie
(S)
Antonios Politis
(A)
Otilia Postea
(O)
Jemma Regan
(J)
David Reeves
(D)
David Renaud
(D)
Zoe Simkin
(Z)
Monique Termote
(M)
Chryssoula Thodi
(C)
Lucas Wolski
(L)
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