Year 1 Progress Report
Poor mental health, hearing and vision impairment are all within the top 10 highest burden of disease within the EU, and are very important from the perspective of public health. Mental ill-health costs the EU over €277 billion/year (2005). Poor mental health, hearing and vision impairment frequently co-occur and are all strongly associated with age and due to ageing population demographics, the numbers of people with these conditions are set to increase. For hearing and vision impairment, numbers will double by 2030. Mental and cognitive health and sensory impairment are not independent. Hearing loss and vision impairment is linked to depression, poor cognitive function, social isolation, and reduced quality of life. To address this, SENSE-Cog’s aims are to: (1) understand the inter-relationship of sensory and cognitive impairments; (2) identify novel means of screening/detection for diagnostic and therapeutic purposes; and (3) translate this knowledge into clinical applications for the mental well-being of EU citizens.
Work performed from 1 January 2016 to 30 June 2017
Work-Package 1: Exploration
Using existing data from six different aging cohorts, we undertook in-depth epidemiological analyses to explore in detail the associations of vision and/or hearing loss with anxiety, depression, suicidal ideation, trajectory of cognitive decline and risk of dementia. Using the Tromsø Study data from Norway, we examined associations of anxiety and depression with hearing and vision loss. We examined similar questions using the Three City (3C) Study dataset from three cities in France, including associations with different dimensions of depression and suicidality. Concurrently, using English (English Longitudinal Study of Aging) and pan-European longitudinal datasets, we undertook complex growth curve analyses to understand the trajectory of cognitive decline in people with hearing and vision impairment over time and risk of developing dementia. Finally, using data from the Rotterdam Study of Aging, we sought associations between the risk of developing dementia and particular changes in the retina of the eye. Retinal changes have the potential to be an early marker for the onset of Alzheimer disease and other dementias.
Work-Package 2: Assessment
In this Work Package, we sought to improve aspects of assessment in people with combined sensory and cognitive problems. Under- and un-treated sensory impairments, which are common in elderly people with dementia (PwD), are associated with poorer mental health, more rapid cognitive decline, reduced social interactions and poor quality of life. A key factor in the high rates of under- and un-treated sensory impairment is the lack of valid and reliable assessment tools for these domains. People with cognitive impairment or PwD, often do not report hearing and vision impairments. Likewise, people with hearing and vision problems have difficulty completing cognitive assessment tests, since most of these tests rely on intact hearing and vision. Thus, the care of people with these combined problems is often sub-optimal. To address this, we undertook the following tasks:
• A gold-standard critical review of the presence and utility of existing cognitive assessment tools that have been adapted for people with sensory impairment;
• A stakeholder needs’ analysis involving people with dementia (PwD), caregivers and health care professionals from France, Cyprus and the UK, describing the needs of PwD, their care partners and healthcare professionals in relation to assessment of hearing, vision and cognitive impairment in older adults;
• A synthesis of the findings from the review and the stakeholders’ needs analysis to select and adapt specific cognitive and sensory assessment tools that we will validate and make available to the general public and health care professionals in the next part of the research.
Work-Package 3: Intervention
Intervening to improve sensory function could be a means by which the lives of people living with dementia (PwD) may be improved. Despite this, very few studies have tried to improve outcomes in dementia by supporting sensory function. However, straightforward correction of hearing and vision impairments in the context of more serious cognitive deficits such as dementia is unlikely to succeed. This is due to the added complexity of concurrent deficits as well as the low rate of access to vision and hearing services in elderly people. Clearly, a more comprehensive approach to improving outcomes in PwD and sensory impairment is required. A possible solution to this issue is to provide added ‘sensory support’ to PwD who live at home. Thus, the goal of Work Package 3 is to develop a ‘sensory support intervention’ that can be trialled in PwD who have hearing and/or vision problems to improve their quality of life. To do this, we undertook a series of studies to gather the components and method of implementation of such an intervention. The studies were part of a process of ‘intervention mapping’ in which we did the following:
• scoping the gaps in understanding, awareness and service provision for the hearing and/or vision impairment care needs of PwD by means of a systematic literature review and Expert Reference Group;
• investigating the specific support care needs through stakeholder surveys, focus groups, semi-structured interviews and an Expert Reference Group, leading to a prototype sensory support package;
• refining the prototype intervention by additional input from stakeholders using focus groups and semi-structured interviews; and
• field testing the draft intervention using an open-labelled, non-randomised feasibility study to develop the final intervention and implementation methods ready for full scale definitive trialling.
Within this Work Package (WP), our work to date as also included formation of the SENSE-Cog ‘Trial Development Team’ to develop the study protocol, training materials, and Standard Operating Procedures for the full-scale, multi-centred randomised controlled trial (RCT) of the newly developed ‘sensory support intervention’ that is due to start in January 2018. This work also entailed developing the role of the ‘sensory support therapist’ (a new type of professional), training materials and treatment manual for this role. A ‘prototype’ therapist and senior therapist joined the team to take this work forward in preparation for the RCT. The protocol and RCT materials have now being submitted for ethical and other approvals.
Work-Package 4: Valuation
To effectively improve the mental well-being of elderly Europeans with co-morbid mental health, cognitive and sensory impairments requires, an understanding of the health economic aspects of these combined problems is essential. In this Work Package (WP), we are studying the health economic resource use and associated cost of the interaction among mental and cognitive health aspect(s) and sensory impairment in the existing EU population databases. This involves estimating the cost of health care resource utilisation of mental health and sensory impairment (visits to the doctor, visits to the GP and hospitalisations) for the older population based on the pan-European SHARE (Survey of Health Ageing and Retirement in Europe) meta-dataset, which includes data from the older population in Austria, Belgium, Denmark, France, Germany, Italy, the Netherlands, Spain, and Switzerland.
Another task in this WP is has been the preparatory work for ascertaining the cost-effectiveness of the sensory support intervention developed in WP3, which is to be trialled in the next phase of work in WP3. To do this, we first had to determine the best tools to measure resource use and quality of life in dementia-related interventions. This involved a detailed systematic review of the literature, as well as a focus group with dementia experts, which included nurses, clinical researchers in dementia and other health economists. These studies revealed that the Client Services Receipt Inventory (CSRI) is the most suitable choice to ascertain resource use and EuroQol 5-dimension (EQ-5D), Short Form-12 (SF-12) and disease-specific DEMQOL are best-suited to measure quality of life. This enabled us to develop our health economics’ data collection tools for the SENSE-Cog RCT, together with the Trial Development Team from WP3, and test out their utility and acceptability in WP3’s SENSE-Cog Field Trial of the draft intervention.
Work-Package 5: Involvement
Involving people with dementia (PwD) and their care partners, as well as the public, is a crucial aspect of conducting meaningful research. The goal of this Work Package (WP) has been to establish a ‘Research User Group’ (RUG) of lay members to support, inform and guide the entire SENSE-Cog research programme and ensure that we are meeting the needs of PwD and their care partners. To do this, with our partner sites across the EU, we have established a network of RUGs, each comprised of 7-10 people living with cognitive ill-health and/or hearing/vision impairment and their friends and family. The groups have trained in the principles of research to equip them to give meaningful advice about the running of the SENSE-cog research programme. The groups meet regularly to support the SENSE-cog researchers regarding a multitude of aspects of the research, including the appropriateness of the study materials, which research questions to focus on, how research participants should be recruited for the study, the acceptability and tolerability of the chosen outcome measures, the clinical meaningfulness of results, and how to tell people about the results of the research. A public website has been developed, and twitter and linkedin social media accounts have been set up. We have held several public engagement events in Nice and Manchester to share with members of the public the results of the research so far.
Results and potential impact
Work-Package 1: Exploration
Prior to our work in SENSE-Cog, the literature on the associations of mental illness and cognitive and sensory impairment was scarce. By analysing extensive data from multiple large-scale aging cohorts and one pan-European aging meta-dataset, we have added significantly to the understanding of the associations among anxiety and depression and hearing and vision impairment. Using unique datasets from different EU countries has enabled us to verify our findings and strengthen our conclusions. Key findings thus far include: (1) dual (hearing and vision combined) sensory loss may pose a significantly increased risk for depression in elderly people; (2) mild and severe hearing loss is associated with new onset depression; (3) anxiety is uniquely related to hearing loss and over a several year period subthreshold anxiety symptoms may emerge; and (4) suicidal risk is greater in older people with hearing and/or vision loss or both.
Our examinations of associations over longer periods are particularly important and have deepened the understanding of the trajectory of cognitive decline in relation to sensory impairment, particularly in the very old population (over 90s). Until our SENSE-Cog studies using ELSA and the pan-European SHARE data set, epidemiological data on the relation between sensory impairment and cognitive decline were scarce and inconsistent. Describing and understanding trajectories of cognitive decline and how they relate to sensory impairments may offer insight into the dynamics of cognitive decline and identify opportunities for intervention to maximise cognitive function and longevity in older age.
Overall, the analyses performed in WP1 have generated an unprecedented body of evidence of the epidemiological associations in this field.
Work-Package 2: Assessment
In our critical review of the existing literature, we found that some attempts have been made to adapt cognitive tests for people with acquired hearing and/or vision impairment, but the validity of the adapted scales has not been established. Thus, we have clearly identified the need to improve cognitive assessments for people with hearing and vision impairment. We have also laid the ground work for developing an on-line screening tool for people to self-manage their sensory and cognitive health by determining whether they have a clinically significant problem in hearing, vision or cognition. This will foster early identification and treatment. The tool will be inexpensive and widely available via smartphone and computer platforms, usable by non-experts, and applicable with hard-to-reach populations across gender, geographical location, socio-economic status and ethnicity.
Work-Package 3: Intervention
This is the most comprehensive programme to address the crucial issue of the growing number of people in the European Union (EU) with comorbid dementia, hearing and vision impairment. Taking place in several EU countries, it has used a range of research methods to integrate different levels of evidence to address a key EU societal objective – improving mental-well in elderly people. At this point, the WP3 intervention development programme represents the logical development and modelling of a complex intervention to fulfil an unmet need. It is based on a theoretical framework and has formed the basis of the upcoming full scale SENSE-Cog efficacy trial. We have now determined: (1) the causal assumptions about mechanisms of change through which the intervention may work and created a logic model; (2) the method to assess participants’ level of hearing and vision impairment and range of functional needs in a home-based setting; (3) how the intervention will be tailored to the specific needs of the participant; (4) what the individual components (e.g. modules) of intervention will be; and (5) how the intervention will be implemented (e.g. duration, frequency and delivery of each component); and (7) how the intervention will work in the context of different EU settings.
Work-Package 4: Valuation
Our econometric analyses from the SHARE meta-dataset have already contributed important new findings by revealing that, in some cases, cognitive and sensory impairments are significantly associated with higher utilisation of health care services (more hospitalisations and more GP visits), even after controlling for other major health conditions. This has important implications and strengthens the case for improved recognition and support of these frequently co-occurring conditions in older people in Europe. Furthermore, this work has resulted in an important technical paper in which methods of analysis have been outlined.
The preparatory work for the SENSE-Cog RCT, including the critical review of tools for dementia-related cost effectiveness evaluations, is also a significant contribution to the field of dementia studies. The findings now enable us to determine the best available resource use and quality of life scales for dementia-related trial health economic analyses. The tools chosen for the RCT entailed translation into Greek and French, which we have done, thereby contributing to greater accessibility to these important instruments and fostering standardisation of cost effectiveness assessment across centres. Determining the cost effectiveness of a new intervention such as SENSE-Cog’s ‘sensory support intervention’ is a crucial aspect of ensuring that the intervention, if efficacious, is eventually implemented in clinical services across the EU.
Work-Package 5: Involvement
Involving people who have experienced cognitive and/or sensory impairments in the research and effectively communicating the results of the research has been a key aim of the SENSE-Cog Work Package 5 programme. To date, we have had successful public engagement events with over 250 people and have shared our results in various ways, including our website, through social media, and through interviews and lay articles. Our activities with our lay members have spread the principles and methods of ‘patient and public involvement’ (PPI) to all our partner countries. This ensures that there is public ownership of health research and that the research outputs are used appropriately and effectively. Our PPI work is building on prior models for public involvement in health research in: (1) establishing a model for cross-European public involvement in health research; (2) establishing training and support structures for public involvement in health research; and (3) quantifying the impacts and benefits of public involvement in the SENSE-cog study to promote mental well-being in elderly Europeans. Finally, we are also involved in formally evaluating our methods of lay engagement to ensure that the SENSE-cog project will provide a gold standard model for public involvement in health research in Europe.
The outcomes of this part of the SENSE-Cog programme are relevant to clinicians, older adults, people with sensory and cognitive impairments, NGOs, industry and government policy-makers. To ensure maximum impact and use of results, relevant stake holders are included in a steering committee with input to development, running, analysis, interpretation, dissemination and engagement activities. This project has established an EU of patient are carer representatives, and will produce a training package for development of EU research user groups.