Emma Hooper1, Zoe Simkin1, Harvey Abrams2, Elizabeth Camacho3, Anna Pavlina Charalambous4, Fideline Collin5, Fofi Constantinidou6, Piers Dawes7, Rachel Elliott3, Sue Falkingham8, Eric Frison5, Mark Hann9, Catherine Helmer10, Ines Himmelsbach11, Hannah Hussain3, Sarah Marié12, Susana Montecelo12, David Reeves9, Jemma Regan13, Chryssoula Thodi4, Lucas Wolski11, Iracema Leroi1,14,15. 1. Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, United Kingdom. 2. University of South Florida, Tampa, Florida. 3. Manchester Centre for Health Economics, School of Health Sciences, University of Manchester, Manchester, United Kingdom. 4. Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus. 5. INSERM, EUCLID/F-CRIN Clinical Trials Platform, Bordeaux Population Health Center, CHU Bordeaux, F-33000, University of Bordeaux, Bordeaux, France. 6. Department of Psychology and Center for Applied Neuroscience, University of Cyprus, Nicosia, Cyprus. 7. Manchester Centre for Audiology and Deafness, University of Manchester, Manchester, United Kingdom. 8. Starkey Hearing Technologies, Stockport, United Kingdom. 9. Centre for Biostatistics, University of Manchester, Manchester, United Kingdom. 10. INSERM, Bordeaux Population Health Research Center, Team LEHA, University of Bordeaux, Bordeaux, France. 11. Catholic University of Applied Sciences Freiburg, Freiburg, Germany. 12. Essilor International, Research & Development, Paris, France. 13. University of Manchester, Manchester, United Kingdom. 14. Global Brain Health Institute, Trinity College Dublin, Dublin, Ireland. 15. Greater Manchester Mental Health Foundation Trust, Manchester, United Kingdom.
Abstract
OBJECTIVES: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. DESIGN: An international single-arm open-label feasibility, acceptability, and tolerability study. SETTING: Home-based setting in the United Kingdom, France, and Cyprus. PARTICIPANTS: Adults aged 60 years and older with mild-to-moderate dementia and uncorrected or suboptimally correctedhearingand/or vision impairment, and their study partners (n = 19 dyads). INTERVENTION: 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. MEASUREMENTS: Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews. RESULTS: 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. CONCLUSION: 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.
RCT Entities:
OBJECTIVES: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. DESIGN: An international single-arm open-label feasibility, acceptability, and tolerability study. SETTING: Home-based setting in the United Kingdom, France, and Cyprus. PARTICIPANTS: 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). INTERVENTION: 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. MEASUREMENTS: Ratings of study procedure feasibility, and intervention acceptability/tolerability, ascertained through questionnaires, participant diaries, therapist logbooks, and semistructured interviews. RESULTS: 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. CONCLUSION: 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.
Authors: Fiona Höbler; Katherine S McGilton; Walter Wittich; Kate Dupuis; Marilyn Reed; Shirley Dumassais; Paul Mick; M Kathleen Pichora-Fuller Journal: J Alzheimers Dis Date: 2021 Impact factor: 4.472
Authors: Iracema Leroi; Christopher J Armitage; Fidéline Collin; Eric Frison; Mark Hann; Emma Hooper; David Reeves; Zoe Simkin; Lucas Wolski Journal: Trials Date: 2020-02-24 Impact factor: 2.279