Dataset Information

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial.

ABSTRACT:

Objectives

Hearing, vision, and cognitive impairment commonly co-occur in older adults. Improving sensory function may positively impact outcomes in people with dementia (PwD). We developed a "sensory intervention" (SI) to support hearing and vision in PwD. Here, we report the findings of an international open-label field trial, and nested case series, to explore the impact of the SI on dementia-related outcomes.

Methods

This was a home-based trial conducted in France, England, and Cyprus. Participants were people with mild-to-moderate dementia and hearing and/or vision impairment (n = 19) and their study partners (unpaid carers; n = 19). The "basic" SI included a hearing and vision assessment and provision of glasses and/or hearing aids. A subsample received the "extended" SI with additional weekly visits from a sensory support therapist (SST). Exploratory analyses of dementia-related, health utility and resource utilisation outcomes were performed.

Results

Quality of life (QoL) and sensory functional ability improved. Change in QoL exceeded the threshold for a minimum clinically important difference. There was a modest improvement (in absolute terms) post intervention in behavioural disturbance, self-efficacy, and relationship satisfaction. Study partner time assisting instrumental activities of daily living (iADL) and supervision decreased by about 22 and 38 hours per month, respectively, although time for personal ADL support increased. Qualitative data supported effectiveness of the intervention: PwD were more socially engaged, less isolated, less dependent on study partners, and had improved functional ability and communication.

Conclusions

These findings support the need for a definitive randomised controlled trial (RCT) to evaluate the effectiveness of the intervention.

SUBMITTER: Leroi I

PROVIDER: S-EPMC7079053 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Publications

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial.

Leroi Iracema I Simkin Zoe Z Hooper Emma E Wolski Lucas L Abrams Harvey H Armitage Christopher J CJ Camacho Elizabeth E Charalambous Anna Pavlina AP Collin Fideline F Constantinidou Fofi F Dawes Piers P Elliott Rachel R Falkingham Sue S Frison Eric E Hann Mark M Helmer Catherine C Himmelsbach Ines I Hussain Hannah H Marié Sarah S Montecelo Susana S Thodi Chryssoula C Yeung Wai Kent WK

International journal of geriatric psychiatry 20191203 4

<h4>Objectives</h4>Hearing, vision, and cognitive impairment commonly co-occur in older adults. Improving sensory function may positively impact outcomes in people with dementia (PwD). We developed a "sensory intervention" (SI) to support hearing and vision in PwD. Here, we report the findings of an international open-label field trial, and nested case series, to explore the impact of the SI on dementia-related outcomes.<h4>Methods</h4>This was a home-based trial conducted in France, England, an ...[more]

PMID: 31713262

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Project description:IntroductionQuality of life and other key outcomes may be improved by optimising hearing and vision function in people living with dementia. To date, there is limited research assessing the efficacy of interventions aimed at improving hearing and vision in people with dementia. Here, we outline a protocol to field test a newly developed home-based intervention, designed to optimise sensory functioning in people with dementia in three European sites. The results of this study will inform the design and conduct of a full-scale randomised controlled trial (RCT) in five European sites.Methods and analysisIn this multisite, single arm, open label, feasibility study, participants with dementia (n=24) will be assessed for hearing and vision impairments and be prescribed a hearing aid and/or glasses. Each participant will have a study partner ('dyads'). A subset of dyads will receive 'sensory support' from a 'sensory support therapist', comprising home visits over 12 weeks. The therapist will offer the following intervention: adherence support for corrective devices; adaptations to the home environment to facilitate sensory function; communication training; and referral to community-based support services. The primary outcomes will be process measures assessing the feasibility, tolerability and acceptability of: (1) the intervention components; (2) the method of implementation of the intervention and (3) the study procedures, including outcome assessment measures. Quantitative data will be collected at baseline and follow-up. Qualitative data using semistructured interviews will be collected postintervention and weekly, using participant diaries. Finally, we will explore a model of cost-effectiveness to apply in the subsequent full-scale trial. This feasibility study is a necessary step in the development of a complex, individualised, psychosocial intervention. The data gathered will allow logistical and theoretical processes to be refined in preparation for a full-scale RCT.Ethics and disseminationEthical approval was obtained in all three participating countries. Results of the field trial will be submitted for publication in a peer-reviewed journal.

Project description:Hearing and vision impairments are among the most common and disabling comorbidities in people living with dementia. Intervening to improve sensory function could be a means by which the lives of people living with dementia may be improved. However, very few studies have tried to ameliorate outcomes in dementia by improving sensory function. This paper describes the multi-step development of a new intervention designed to support hearing and vision function in people living with dementia in their own homes. At the end of the development programme, it is anticipated that a 'sensory support' package will be ready for testing in a full scale randomised controlled trial.This programme is based on the process of 'intervention mapping' and comprises four integrated steps, designed to address the following: (1) scoping the gaps in understanding, awareness and service provision for the hearing and/or vision impairment care needs of people with dementia using a systematic literature review and Expert Reference Group; (2) investigating the support care needs through a literature search, stakeholder surveys, focus groups, semi-structured interviews and an Expert Reference Group, leading to a prototype sensory support package; (3) refining the prototype by additional input from stakeholders using focus groups and semi-structured interviews; and (4) field testing the draft intervention using an open-labelled, non-randomised feasibility study, integrating feedback from people with dementia and their significant others to develop the final intervention ready for full scale definitive trialling. Input from the 'patient and public voice' is a cornerstone of the work and will interlink with each step of the development process. The programme will take place in study centres in Manchester, Nicosia and Bordeaux.Quantitative and qualitative data analyses will be employed, dependent upon the sub-studies in question. Data from the steps will be integrated with consideration given to weighting of evidence for each step of the programme. This programme represents the logical development of a complex intervention to fulfil an unmet need. It is based on a theoretical framework and will lead to a subsequent full scale efficacy trial. The challenges in integrating the data and addressing the contextual issues across study sites will be scrutinised.

Project description:BackgroundHearing 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.MethodsThis 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.DiscussionThis 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 registrationISRCTN (Trial ID: ISRCTN17056211 ) on 19 February 2018.

Project description:BackgroundClinical endpoints for upcoming therapeutic trials in frontotemporal dementia (FTD) are increasingly urgent. Cognitive composite scores are often used as endpoints but are lacking in genetic FTD. We aimed to create cognitive composite scores for genetic frontotemporal dementia (FTD) as well as recommendations for recruitment and duration in clinical trial design.MethodsA standardized neuropsychological test battery covering six cognitive domains was completed by 69 C9orf72, 41 GRN, and 28 MAPT mutation carriers with CDR® plus NACC-FTLD ≥ 0.5 and 275 controls. Logistic regression was used to identify the combination of tests that distinguished best between each mutation carrier group and controls. The composite scores were calculated from the weighted averages of test scores in the models based on the regression coefficients. Sample size estimates were calculated for individual cognitive tests and composites in a theoretical trial aimed at preventing progression from a prodromal stage (CDR® plus NACC-FTLD 0.5) to a fully symptomatic stage (CDR® plus NACC-FTLD ≥ 1). Time-to-event analysis was performed to determine how quickly mutation carriers progressed from CDR® plus NACC-FTLD = 0.5 to ≥ 1 (and therefore how long a trial would need to be).ResultsThe results from the logistic regression analyses resulted in different composite scores for each mutation carrier group (i.e. C9orf72, GRN, and MAPT). The estimated sample size to detect a treatment effect was lower for composite scores than for most individual tests. A Kaplan-Meier curve showed that after 3 years, ~ 50% of individuals had converted from CDR® plus NACC-FTLD 0.5 to ≥ 1, which means that the estimated effect size needs to be halved in sample size calculations as only half of the mutation carriers would be expected to progress from CDR® plus NACC FTLD 0.5 to ≥ 1 without treatment over that time period.DiscussionWe created gene-specific cognitive composite scores for C9orf72, GRN, and MAPT mutation carriers, which resulted in substantially lower estimated sample sizes to detect a treatment effect than the individual cognitive tests. The GENFI-Cog composites have potential as cognitive endpoints for upcoming clinical trials. The results from this study provide recommendations for estimating sample size and trial duration.

Project description:ImportanceImpairments in vision or hearing are common and have been independently linked to higher risk of dementia in older adults. There is a limited understanding of the prevalence of concurrent functional vision and hearing impairment (dual sensory impairment) and its contribution to dementia risk.ObjectiveTo examine the age-specific prevalence of functional dual sensory impairment among older adults, and to investigate the cross-sectional and 7-year longitudinal associations between functional dual sensory impairment and dementia.Design, setting, and participantsThis cohort study of 7562 older adults used data from the US National Health and Aging Trends Study (NHATS), a nationally representative cohort study of community-dwelling, Medicare beneficiaries aged 65 years and older in the US. Participants in the study with complete data on hearing, vision, and dementia were included in analysis. Data were collected between 2011 and 2018, and between March 2018 and May 2020.ExposuresSelf-reported functional sensory impairments (ie, no sensory impairment, functional vision impairment only, functional hearing impairment only, and functional dual sensory impairment).Main outcomes and measuresAge-specific prevalence of functional sensory impairments was calculated. Generalized linear regression with a complementary log-log link and a discrete time proportional hazards model with a complementary log-log link were used to assess the cross-sectional and 7-year longitudinal hazard of dementia.ResultsOf 7562 participants, 3073 (40.7%) were ages 80 years or older and 4411 (58.3%) were women. Overall, 5.4% (95% CI, 4.7%-6.1%) of participants reported functional vision impairment only, 18.9% (95% CI, 18.9%-17.8%) reported functional hearing impairment only, and 3.1% (95% CI, 2.7%-3.5%) reported functional dual sensory impairment (prevalence estimates are weighted). Participants reporting sensory impairments were older (no impairment: age ≥90 years, 2.12% [95% CI, 1.79%-2.46%] vs functional dual sensory impairment: age ≥90 years, 20.06% [95% CI, 16.02%-24.10%]), had lower education (no impairment: <high school, 19.05% [95% CI, 17.27%-20.83%] vs functional dual sensory impairment: <high school, 46.15% [95% CI, 38.38%-53.92%]), and greater disease burden (eg, heart disease: no impairment, 15.30% [95% CI, 14.04%-16.55%] vs functional dual sensory impairment, 25.49% [95% CI, 19.96%-31.02%]). Compared with no impairment, functional vision impairment (adjusted hazard ratio [aHR], 1.89; 95% CI, 1.57-2.28), functional hearing impairment (aHR, 1.14; 95% CI, 1.00-1.31), and functional dual sensory impairment (aHR, 2.00; 95% CI, 1.57-2.53) were associated with a higher cross-sectional hazard of dementia. Over 7 years, functional vision impairment (aHR, 1.40; 95% CI, 1.12-1.74), functional hearing impairment (aHR, 1.09; 95% CI, 0.95-1.24), and functional dual sensory impairment (aHR, 1.50; 95% CI, 1.12-2.02) were associated with a higher hazard of incident dementia compared with no impairment.Conclusions and relevanceIn this cohort study of US Medicare beneficiaries, dual sensory impairment was prevalent in older adults and associated with increased risk of dementia. These findings suggest that sensory rehabilitative interventions for multiple impairments may be an additional resource in efforts to reduce dementia risk.

Project description:Plain English summary:Involving older people with dementia in research is increasingly recognised as important to ensure that research is relevant and beneficial for older people with dementia. But researchers need to know how best to involve older people with dementia and to be able to show the benefits of involving older people with dementia in dementia research.This paper describes a research plan to explore the involvement of older people with dementia and age-related hearing and/or vision impairment in a European research project investigating the combined impact of dementia with hearing and/or vision impairment. We set up four Research User Groups (RUGs) of older people with dementia with age-related hearing and/or vision impairment and their carers based in the UK, France, Cyprus and Greece to advise our researchers. We provided training to group members to support their input to the research.We will use a questionnaire and interview people in our RUGs to understand what they thought of the training and their experiences of being part of the RUG. We will also interview researchers to understand if they thought the advice from the groups was useful.This study will help us to understand how to effectively involve older people with dementia and age-related hearing and/or vision impairment in research and what the benefits of involving older people with dementia in research are. Abstract:Background Research to prevent and treat dementia is an international priority. Involvement of older people with dementia in the research is important to ensure the relevance and utility of the research outcomes in clinical practice to them. Efforts to involve such people in research are growing due to increased recognition of the usefulness of incorporating the views of older people with dementia into the research process. Research User Groups (RUGs) of older people with dementia and carers for people with dementia were set up in UK (Manchester), France (Nice), Cyprus (Nicosia) and Greece (Athens) to advise on the research. We report a protocol for a study which aims to evaluate i) the perceptions of RUG members of the usefulness of Research Awareness Training that was provided to support their involvement in the research and ii) perceived impacts of the involvement of older people with dementia and age-related hearing and/or vision impairment on research from the point of view of RUG members and researchers. Methods Both qualitative and quantitative methods will be used to evaluate the acceptability, appropriateness and satisfaction with Research Awareness Training and the perceived impact of involvement of RUGs on research. Focus groups interviews with RUG members and one to one interviews with both RUG members (n =?24) and researchers (n =?6) will be conducted to understand the perceived impacts of patient and public involvement on research from the point of view of older people with dementia, carers and researchers. Any comparative differences in cultural, attitudinal and environmental differences between RUGs in outcomes of training and impact across the four European sites will be reported. Discussion This study is unique in its exploration of the impact of the involvement of older people with dementia and age-related hearing and/or vision impairment in a large multi-site European dementia research study. This work will be crucial in informing understanding of how to effectively involve older people with dementia and age-related hearing and/or vision impairment and carers in dementia research to ensure research addresses the needs and priorities of older people with dementia and age-related hearing and/or vision impairment.

Dataset Information

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial.

Objectives

Methods

Results

Conclusions

Publications

Impact of an intervention to support hearing and vision in dementia: The SENSE-Cog Field Trial.

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