Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
This is a brief of broader scope from which the Health Technology Assessment (HTA) Programme is interested in potentially funding more than one proposal.
The HTA programme is interested in proposals for the evaluation of the effectiveness and economic analysis of music-based interventions to improve the care and support for people living with dementia and their carers. 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 rationale of study design, outcome measures, and explain how the research will fit into the remit of the HTA programme.
Intervention(s)
Music therapy or music-based interventions. Any music-based intervention or community music activity including individual or group sessions, active or passive activity such as listening to music, singing, playing an instrument, or music with movement. The intervention could be provided by informal or formal carers, health and social care staff, researchers, musicians, therapists. The intervention and its possible components should be clearly described.
Target group
People living with mild, moderate or severe dementia from young to older onset. Inclusion criteria to be defined and justified by the applicants as relating to their particular research question. Consideration should be given to issues of consent and participant evaluation of impact of intervention.
Setting
Home, community, residential care, or any other appropriate health or social care setting.
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 in this field. The term ‘dementia’ is complex, referring to a range of diseases with different causes, symptoms and progression. This high degree of variation creates challenges when trying to speak collectively on the topic and does not always reflect the diversity and plurality of individuals and experience. Where possible, applicants should demonstrate true and active involvement of people affected by dementia (both people living with dementia and carers) from the first design stages and throughout the study. 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 process evaluation
- Appropriate methods for large scale, rigorous and innovative studies. RCTs, longitudinal and rigorous quasi-experimental (for example, comparative interrupted time series designs and regression discontinuity designs) designs, with qualitative components, are encouraged. Noting that for singing and other creative activity, random assignment to an intervention that one would not choose is counterproductive and possibly adds risk for this population.
- To describe fully, document and standardise, where possible, the interventions themselves – not only outcomes - in order to yield replicable results.
- Intervention and measurement that is appropriate to the population in the study and, where appropriate, the use of bio-monitoring as potential indicators of the subjective worlds of the participants or where it is considered helpful for ‘in the moment’ measurement of responses.
- Equality, diversity and inclusion, paying attention to populations that have been underserved and to promote inclusion of a diversity of participants. This is particularly important due to the strong cultural basis to music experiences.
- The interactive and dynamic nature of taking part in creative activity, whether as an individual or as part of a group; consideration of, where appropriate, social contexts and intra-group interaction.
Important outcomes
Quality of life; well-being; non-pharmacological management of stress and distress; social care outcomes; unintended effects of intervention, measures of engagement appropriate for the target population and intervention (for example, Music in Dementia Assessment Scales), subjective perspectives on outcomes for people living with dementia; experiences of people with dementia and carers.
Rationale
Dementia is a syndrome causing deterioration in cognitive abilities and functioning, usually chronic and progressive in nature, beyond that normally expected with ageing (World Health Organization, 2022). Domains also affected by dementia may include memory, language, comprehension, motivation, vision, orientation and some executive function. A person’s behaviour may also be affected, with changes in interpersonal interactions and personality, alongside withdrawal, emotional control and agitation.
Dementia can result from a variety of conditions and the term covers various forms including Alzheimer’s-type dementia, vascular dementia, frontotemporal dementia and dementia with Lewy bodies and less commonly known dementias that are often younger onset before the age of 65, such as posterior cortical atrophy, primary progressive aphasia, familial Alzheimer’s, and familial frontotemporal. Younger onset dementia presents a range of difficulties and issues for people who are mostly of working age and are financially dependent on employment, may still have parenting responsibilities, provide care for older family members and remain too young for pension benefits (Cartwright et al, 2021). Anti-dementia medicines and disease-modifying therapies developed to date have limited efficacy and are primarily labelled for Alzheimer’s disease, although new treatments are being investigated in various stages of clinical trials (World Health Organization, 2022).
Among the 885,000 people with dementia in the UK, 127,000 have mild dementia, 246,000 have moderate dementia and 511,000 have severe dementia (Wittenberg et al, 2019). One in 14 people over the age of 65 have older onset dementia and the condition affects 1 in 6 people over 80 years old (Age UK). An overall international age-standardised prevalence of 119.0 per 100,000 population in the 30-64 age range was more recently estimated for younger onset dementias, equating to 3.9 million people worldwide (Hendriks, et al, 2021).
A taskforce of leading UK researchers, clinicians, research funders and people affected by dementia produced the Dementia Research Roadmap, developing goals and recommendations to advance dementia research. Priorities for research included approaches to improve quality of life and wellbeing, as well as research to understand and meet the needs of people with severe dementia, to optimise quality of life. The All-Party Parliamentary Group on Arts, Health and Wellbeing reported on the arts in health and social care, highlighting how the arts can play a part in many aspects of dementia care, with music particularly being a powerful communication tool that remains accessible to people even in the advanced and later stages of dementia. Recent government initiatives include the announcement of a 10-year plan which will contain a focus on supporting people with their health and care needs while living with dementia.
Music-based interventions can have many benefits in dementia care including tackling anxiety and depression, enhancing quality of life and wellbeing, and minimising behavioural and psychological symptoms of dementia (BPSD) including symptoms such as agitation and aggression. Other reported benefits include retaining speech and language, reduction in the use of antipsychotic drugs, supporting palliative and end of life care and improving carer wellbeing.
The HTA programme wishes to commission research evaluating music-based interventions to improve dementia care and outcomes for people living with dementia and carers, taking into account published and ongoing research in the field. The study focus and design should be defined and justified by applicants and are not limited to the examples given in this brief. The programme would be interested in new and innovative methodologies, measures and outcomes appropriate to the population and intervention.
To support the ambitions of NIHR’s Best Research for Best Health: the next chapter, NIHR strongly encourages the inclusion of nurses, midwives and allied health professionals within well-developed research teams responding to this call, to increase the building of nurse, midwife and allied health professional-related research activity, capacity and capability across the professions. Depending on the level of experience, this could be through the role of lead applicant, as joint co-applicant supported by detailed mentoring plans submitted with the application, or as a co-applicant member of the research team. Through this activity, NIHR aims to support nurses, midwives and allied health professionals to become future research leaders and release the potential to lead, use, deliver and participate in research as a part of their job.
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
Your application must be submitted online no later than 1pm on 29 November 2023. Applications will be considered by the HTA Funding Committee at its meeting in January 2024.
HTA Programme Stage 1 guidance notes are available, alongside supporting information for applicants.
Please note that shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2024.
Applications received electronically after 1pm on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application, 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. Both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact htacommissioning@nihr.ac.uk.