Introduction
The Health Technology Assessment (HTA) Programme is interested in proposals for the evaluation of the effectiveness and economic analysis of technology-based interventions to improve the care and support for people living with deafblindness. Applicants should clearly define and justify their choice of target group, with particular focus on the setting and delivery of the intervention. Applicants should demonstrate the rationale for the study design and choice of outcome measures, and explain how the research will fit into the remit of the HTA programme.
- Intervention: Technology or tool(s). Any technology or tool type intervention such as assistive communication tools, haptic devices, or wearable smart technologies. This intervention could be provided by informal or formal carers, researchers or be self-managed. The intervention and its possible components should be clearly described.
- Patient group: People living with deafblindness from young to older onset. Inclusion criteria to be defined and justified by the applicants as relating to their particular research question. Applicants are asked to consider and justify the inclusion of acquired and/or congenital deafblind populations. Consideration should also be given to barriers of participation and participant evaluation of impact of intervention.
- Setting: Any appropriate social care setting (home, community, residential care etc.).
- Study design: In recognition of the nature of this research area, it is anticipated that a prescriptive study design may be limiting. However, any study should be designed to strengthen the evidence base on the effectiveness of technology-based interventions to improve the care and support for people living with deafblindness. Applicants are required to embed an internal pilot phase to test key trial processes such as recruitment, retention and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial. Due to the complex nature of this research area, applicants are invited to embed a methodological sub-study (Study Within A Trial – SWAT) as detailed in the rationale box.
- Applicants should propose a study design appropriate to the population and intervention, and are encouraged to consider the following in the research design:
- The development of a logic model and theory of change for the intervention, and a process evaluation.
- Appropriate methods for large scale, rigorous and innovative studies. RCTs, longitudinal and rigorous quasi-experimental designs with qualitative components are encouraged (for example, comparative interrupted time series designs and regression discontinuity design).
- To describe fully, document and standardise, where possible, the interventions themselves and management as usual for this target group – not only outcomes – in order to yield replicable results.
- Intervention and measurement that is appropriate to the population in the study.
- Equality, diversity and inclusion, paying attention to populations that have been underserved and to promote inclusion of a diversity of participants
- Important outcomes: Quality of life (including loneliness, isolation and mental health), ability to participate in activities of daily living, ability and willingness of people with deafblindness and carers to use the technology, cost effectiveness (including costs incurred by the target group), well-being, social care outcomes, unintended effects of intervention, measures of engagement appropriate for the target population and intervention, experiences of people with deafblindness and their careers.
Rationale
Deafblindness is defined by the Department of Health and Social Care as the loss of sight and hearing to the point where a person's communication, mobility and ability to access information are impacted. This includes the gradual deterioration of a person's sight and hearing over a longer period of time. There are two different types of deafblindness; congenital and acquired. Congenital deafblindness is a term used when someone is born with sight and hearing loss, whilst acquired deafblindness is a term used when someone develops sight and hearing loss later in life, and can affect anyone at anytime of life through illness, accident or aging. It is estimated that more than 450,000 people are deafblind in the UK, with this estimation expected to increase to 610,000 by 2035 due to our aging population. Deafblindness affects people of all ages, including children and young people, but it is more common in older people due to the natural decline in sight and hearing as we get older.
The management of deafblindness can include treating the underlying conditions affecting hearing or vision using medication or surgery. However, it is not always possible to treat the underlying causes of this condition and therefore social care services are available to support these individuals. Technology that facilitates an individual's ability to perform an activity that they otherwise would be unable to do due to their disability is considered an assistive technology. This includes technologies that assist with acquiring new skills, improving mobility, learning, and/or communicating. There is a significant need for communication support for individuals with deafblindness to improve their quality of life, due to the impact of loneliness and isolation. There is a small amount of published evidence available that shows that assistive technology may be effective in assisting and supporting deafblind people in having better social interactions. However, further studies evaluating existing technologies are required to add to this body of research and influence current care guidelines.
The HTA Programme wishes to commission research evaluating technological interventions to improve the quality of life and outcomes for people living with deafblindness, taking into account published and ongoing research in the field.
The HTA Programme acknowledges the complexities affiliated with this research area. This includes, but is not limited to, the potential difficulties related to recruiting and retaining people with deafblindness, in addition to the occurrence of additional neurological, physical and/or medical conditions associated with the condition. It is therefore important for applicants to carefully consider and justify their chosen study focus, target group and design.
As per the considerations in the above brief, proposals are invited to include a methodological sub-study, known as a ‘study within a trial’ or ‘SWAT’. Methodological sub-studies (SWAT) are used to limit study inefficiency and to provide evidence to support future processes and decision-making. Further information on methodological sub-studies can be found on the NIHR website. Applications must include an internal pilot phase to test key trial processes such as recruitment, retention and adherence. Proposals should detail clear stop/go criteria to inform the progression from pilot to full trial. The programme would be interested in new and innovative methodologies, measures and outcomes appropriate to the population and intervention.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk
Making an application
If you would like to apply for this funding opportunity, you can begin your application via the funding opportunity page.
Your application must be submitted online no later than 1pm on the 24 July 2024. Applications will be considered by the HTA Funding Committee at its meeting in September 2024.
Guidance notes and supporting information for HTA Programme applications are available.
Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in January 2025.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please contact htacommissioning@nihr.ac.uk.