ORCID Profile
0000-0003-3685-6735
Current Organisations
Universidade de São Paulo
,
CHU Bordeaux
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Publisher: Springer Science and Business Media LLC
Date: 25-01-2019
Publisher: Elsevier BV
Date: 2021
Publisher: Springer Science and Business Media LLC
Date: 24-02-2020
DOI: 10.1186/S13063-020-4135-4
Abstract: Optimising hearing and vision function may be important in improving a range of outcomes for people living with dementia (PwD) and their companions. The SENSE-Cog cross-national randomised controlled trial (RCT) is evaluating the effectiveness of a sensory intervention (SI) to improve quality of life for PwD with concurrent hearing and/or vision impairment, in five European countries. To ascertain how or why the intervention will, or will not, achieve its outcomes, we have designed a process evaluation to explore potential discrepancies between expected and observed outcomes. This will also help us to understand how context may influence the outcomes. Here we describe the protocol for this process evaluation, which is embedded within the RCT. We will use a mixed methods approach with a theoretical framework derived from the UK Medical Research Council’s’ guidance on process evaluations. It will include the following: (1) evaluating how key aspects of the intervention will be delivered , which will be important to scale the intervention in real world populations (2) characterising the contextual issues, which may shape the delivery and the impact of the intervention in different countries and (3) investigating possible causal mechanisms through analyses of potential moderators and mediators. To avoid bias, we will analyse the process data before the analysis of the main effectiveness outcomes. This evaluation will provide insight into how the complex SENSE-Cog SI will be tailored, enacted and received across the different European contexts, all of which have unique health and social care economies. The findings will provide insight into the causal mechanisms effecting change, and will determine whether we should implement the intervention, if effective, on a wider scale for PwD and concurrent sensory impairment. ISRCTN, ISRCTN17056211 . Registered on 19 February 2018.
Publisher: Wiley
Date: 03-12-2019
DOI: 10.1002/GPS.5231
Publisher: MDPI AG
Date: 13-10-2023
Publisher: Wiley
Date: 29-04-2019
DOI: 10.1111/JGS.15936
Abstract: People with dementia (PwD) frequently experience hearing and vision impairment that is underrecognized and undertreated, resulting in reduced quality of life. Managing these impairments may be an important strategy to improve outcomes in PwD. Our objective was to field-trial a multifaceted sensory intervention (SI) to enhance hearing and vision in PwD. An international single-arm open-label feasibility, acceptability, and tolerability study. Home-based setting in the United Kingdom, France, and Cyprus. Adults aged 60 years and older with mild-to-moderate dementia and uncorrected or suboptimally corrected hearing and/or vision impairment, and their study partners (n = 19 dyads). A sensory intervention (SI), comprising assessment of hearing and vision, fitting of corrective devices (glasses, hearing aids), and home-based support from a sensory support therapist for device adherence and maintenance, communication training, referral to support services, environmental sensory modification, and optimization of social inclusion. Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews. We successfully delivered all intervention components, and these were received and enacted as intended in all those who completed the intervention. No serious adverse events were reported. Acceptability (ie, understanding, motivation, sense of achievement) and tolerability (ie, effort, fatigue) ratings of the intervention were within a priori target ranges. We met recruitment and retention (93.8%) targets in two of the three sites. Participants completed more than 95% of diary entries, representing minimal missing data. Delays in the logistics circuit for the assessment and delivery of hearing aids and glasses were identified, requiring modification. The need for minor modifications to some outcome measures and the inclusion criteria were identified. This is the first study combining home-based hearing and vision remediation in PwD. The positive feasibility, acceptability, and tolerability findings suggest that a full-scale efficacy trial, with certain modifications, is achievable.
No related grants have been discovered for Ana Carolina Basso Schmitt.