Trials
| Autor: | Regan, Jemma, Frison, Eric, Collin, Fidéline, Dawes, Piers, Hann, Mark, Himmelsbach, Ines, Hooper, Emma, Reeves, David, Simkin, Zoe, Thodi, Chryssoula, Yang, Fan, Leroi, Iracema, Abrams, Harvey, Chaghil-Boissière, Nathalie, Charalambous, Pavlina, Constantinidou, Fofi, Gilbert, Camille, Helmer, Catherine, Jury, Francine, Kontogianni, Evangelia, Lawlor, Brian, Matard, Charly, Montecelo, Susana, Marie, Sarah, Politis, Antonios, Postea, Otilia, Renaud, David, Termote, Monique, Wolski, Lucas |
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| Přispěvatelé: | Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Constantinidou, Fofi [0000-0002-7928-8363], Thodi, Chryssoula [0000-0002-2388-9370], Leroi, Iracema [0000-0003-1822-3643], Dawes, Piers [0000-0003-3180-9884] |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Vision
Cost-Benefit Analysis Medicine (miscellaneous) Cathie Marsh Institute LEHA law.invention Study Protocol 0302 clinical medicine Randomized controlled trial Hearing law Outcome Assessment Health Care Clinical endpoint Multicenter Studies as Topic Pharmacology (medical) 030212 general & internal medicine Functional ability Hearing Disorders EUCLID Aged 80 and over F-CRIN Sensory intervention lcsh:R5-920 Informed Consent Cognition 3. Good health Test (assessment) Europe Manchester Institute for Collaborative Research on Ageing USMR lcsh:Medicine (General) Quality of life medicine.medical_specialty ResearchInstitutes_Networks_Beacons/MICRA Vision Disorders 03 medical and health sciences Quality of life (healthcare) Physical medicine and rehabilitation Intervention (counseling) Pragmatic Clinical Trials as Topic medicine Humans Dementia Psychosocial intervention Aged business.industry Patient Selection medicine.disease Sample Size ResearchInstitutes_Networks_Beacons/cathie_marsh_institute [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie business 030217 neurology & neurosurgery |
| Zdroj: | Trials, Vol 20, Iss 1, Pp 1-15 (2019) Regan, J, Frison, E, Collin, F, Dawes, P, Hann, M, Himmelsbach, I, Hooper, E, Reeves, D, Simkin, Z, Thodi, C, Yang, F, Leroi, I, Abrams, H, Chaghil-Boissière, N, Charalambous, P, Constantinidou, F, Gilbert, C, Helmer, C, Jury, F, Kontogianni, E, Lawlor, B, Matard, C, Montecelo, S, Marie, S, Politis, A, Postea, O, Renaud, D, Termote, M & Wolski, L 2019, ' 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 ', Trials, vol. 20, no. 1, 80 . https://doi.org/10.1186/s13063-018-2973-0 Trials Trials, BioMed Central, In press, 20 (1), pp.80. ⟨10.1186/s13063-018-2973-0⟩ |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/s13063-018-2973-0 |
| Popis: | 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 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 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 ISRCTN (Trial ID: ISRCTN17056211) on 19 February 2018. Electronic supplementary material The online version of this article (10.1186/s13063-018-2973-0) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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