Background

Research to prevent and treat dementia as well as improve quality of life for people with dementia is an international priority [1]. Involvement of people with dementia in research is important to ensure the relevance and utility of the research outcomes in clinical practice [2, 3]. There is increasing recognition of the need to involve people with dementia in research due to an increased focus on person-centred care and the attendant requirement to take the views of people with dementia into account [4,5,6]. There is also evidence to suggest the involvement of people with dementia in research has an impact on research, researchers, the organisation and the person involved in the research [7]. Consequently, there is growing interest in understanding how to involve people with dementia as active partners in research [4,5,6].

The rationale for patient and public involvement in research in general is that people with lived experience of a health condition or treatment can offer valuable perspectives to the research process [8, 9]. INVOLVE, the coordinating centre for patient and public involvement in the UK’s National Health Service defines involvement as “research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’, or ‘for them”’ [8]. Involvement can take a number of forms including consultation (e.g. being involved in prioritising research), collaboration (e.g. acting as an advisor on a research project) or user control (e.g. acting as a service user researcher and carrying out the research) [8]. People with dementia may be involved in all stages of the research process [6, 8, 9]. For example, people with dementia may be involved in identifying research priorities relevant to patients and carers [10, 11], developing funding applications [12], enhancing the relevance and feasibility of research to develop effective interventions [13], identifying potential barriers at an early stage in the research [14, 15], contributing to the interpretation of findings [16, 17], and the dissemination of research results [18, 19]. Being involved in research may also provide benefits to people with dementia and their carers including increasing knowledge, enhancing skills, developing networks and new opportunities for involvement [20], meeting with and hearing the opinions of others with dementia [19, 21], improving self-confidence, and offering opportunities to contribute to dementia research in a forum where the views of people with dementia are valued [21].

Study context

This study is being conducted as part of a larger project, ‘SENSE-Cog’, which aims to investigate the combined impact of dementia and age-related hearing and/or vision impairment and to develop new tools to improve quality of life for older Europeans [22]. SENSE-Cog is funded by the European Research Council’s Horizon 2020 research and innovation programme. The project started in January 2016 and will run until December 2020. Involvement of older people with dementia in SENSE-Cog is a significant part of the overall work programme (Fig. 1).

Fig. 1
figure 1

SENSE-Cog work packages. SENSE-Cog aims to investigate the combined impact of dementia and age-related hearing and/or vision impairment and to develop new tools to improve quality of life for older Europeans. The project started in January 2016 and will run until December 2020. Involvement of older people with dementia in SENSE-Cog is a significant part of the overall work programme

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This paper focuses on SENSE-Cog work package five, ‘patient and public involvement’. Older people with dementia and age-related hearing and/or vision impairment and carers are involved in SENSE-Cog research via Research User Groups (RUGs). RUG membership was constrained to people over the age of 65 years to reflect the target population of the SENSE-Cog research study. RUGs are groups of people who are brought together and supported to give their views and input into SENSE-Cog research. Four RUGs have been established at SENSE-Cog partner sites in Manchester, Nice, Nicosia and Athens. RUGs consist of 7–10 older people with dementia and age-related hearing and/or vision impairment and/or their carers.

Prior to recruiting RUG members, we consulted with a group of older people with dementia and their carers affiliated with Manchester Institute for Collaborative Research on Ageing (MICRA) in a focus group discussion to comment on a draft recruitment flyer for RUG members, we asked participants to comment on the wording, presentation and readability of the flyer. We also asked them to advise us on where to advertise the flyers, and on considerations when setting up meetings for older people with dementia and age-related hearing and/or vision impairment. The draft flyer was revised following the focus group recommendations and translated into French and Greek for the RUG sites in Nice, Nicosia and Athens. The flyers were advertised locally in each RUG site through local organisations and networks working with older people with dementia and older people with dementia and age-related hearing and/or vision impairment. For example, for the Manchester RUG recruitment, flyers were distributed via an email list members of the general public interested in aging research, local memory clinics, and charity organisations including the Alzheimer’s Society, Age UK, Manchester Dementia Action Alliance and Action on Hearing Loss. We received relatively few queries about involvement in general and no queries from anyone from Black, Asian and minority ethnic or underserved communities. On reflection, this recruitment method was not very effective in reaching a diverse range of potential participants. A more targeted community outreach approach such as in-person talks to local dementia support groups, organisations working with Black, Asian and minority ethnic or underserved communities could have been a better method of recruiting a more diverse RUG.

For all RUGs, introductory meetings were held to allow members to decide on how the group should operate and function, e.g. the frequency, length and format of meetings and training delivery. All RUGs are supported and managed by a local patient and public involvement coordinator. Local patient and public involvement coordinators were identified among the research team in each study site. Patient and public involvement coordinators have a background in research with people with dementia, and have experience of working with older adults in research settings. All patient and public involvement coordinators speak English, and communicate in English with the patient and public involvement work package coordinator in Manchester, UK. The role of the patient and public involvement coordinator is to arrange meetings, liaise with researchers and develop activities to support the groups’ involvement in the research.

RUGs meet face-to-face every 3 months, as well as ad-hoc individual meetings with up to 2 RUG members (with the option of postal, telephone, e-mail communication, or in person) for any additional involvement tasks identified by the research team that require patient and public involvement. A key element of the patient and public involvement coordinator’s work is the on-going monitoring of the support requirements of each RUG member. During the introductory meetings the patient and public involvement coordinators completed a support and learning needs form [see Additional file 1] with individual RUG members to understand the different support and learning needs within the group. Support and learning needs are continually revised by the patient and public involvement coordinators by telephone conversations 2 weeks before the RUG meeting. Telephone contact was also preferred by those with hearing problems as RUG members with hearing problems had amplified telephones at home. Regular contact with the RUG members helps the patient and public involvement coordinator to be aware of RUG members’ changing needs so that appropriate support can be provided to facilitate involvement. Patient and public involvement coordinators have links with local support services (such as Admiral Nurses and the Alzheimer’s Society in the UK) that can provide RUG members with additional support if needed. Patient and public involvement coordinators used information from the support and learning needs forms to put in place individual support arrangements to facilitate each person’s involvement. For example, for those with vision problems, patient and public involvement coordinators position themselves close to the person and keep still while talking. People with vision problems are provided with training and RUG materials in large font black print on yellow paper. Patient and public involvement coordinators also use verbal cues to direct people’s attention to specific written materials, for example “Look at the first paragraph on page 2 of the hand-out” rather than saying “Look at the hand-out”.

Aims and objectives of the study

This study aims to evaluate i) the acceptability and perceived outcomes of Research Awareness Training that was provided to support the involvement of older people with dementia and age-related hearing and/or vision impairment in the research and ii) the perceived impacts of the involvement of older people with dementia and age-related hearing and/or vision impairment on the research from the point of view of RUG members and researchers (Study time frame: Table 1).

Table 1 Study time frame for Manchester, Nicosia, Nice and Athens sites
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Evaluating acceptability and perceived outcomes of research awareness training

Sample

All RUG members involved in the Research Awareness Training in Manchester, Nicosia, Nice and Athens will be invited to take part in the evaluation of the training. The evaluation will be completed by up to 10 (people) RUG members in each study site (Manchester, Nicosia, Nice and Athens).

Research awareness training

The Research Awareness Training (Fig. 2) was initially developed as part of the Enhancing the Quality of User Involved Care Planning (EQUIP) [23] programme to give UK National Health Service mental health service users and caregivers an understanding of research and research terminology to support them in working as co-researchers on a mental health research project. EQUIP training involved a 6-day research methods course. However we adapted the training to 6 one hour sessions focussing on key research concepts that were relevant for SENSE-Cog. A shorter version of Research Awareness Training than the original 6 day program was developed following discussion with RUG members in each study site during the introductory meetings. RUG members’ preference was for shorter, bite-sized training delivered as needed. Shorter, bite-sized training also facilitated participation of people with memory difficulties.

Fig. 2
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Adapted Research Awareness Training. The adapted Research Awareness Training for RUG members consists of 6 one hour sessions focussing on key research concepts that are relevant for SENSE-Cog. The training was developed following discussion with RUG members in each study site. RUG members’ preference was for shorter, bite-sized training delivered as needed

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Patient and public involvement coordinators for each RUG completed a three day training course in English (Table 2) to orient them to the content of the Research Awareness Training and describe how training should be delivered to RUGs (Table 2). Discussion of the principles of patient and public involvement training and orientation to the SENSE-Cog project was delivered by the Public Programmes Team in Manchester [24]. The Public Programmes Team is a specialist unit advising on and delivering patient and public involvement and engagement in national and international health research [24]. Research Awareness Training for patient and public involvement coordinators was delivered by Professor Karina Lovell and colleagues at the University of Manchester based on a ‘train the trainer model’ [23] to enable the patient and public involvement coordinators to adapt the Research Awareness Training for local implementation appropriate for RUG member’s language, hearing and/or vision impairments.

Table 2 Patient and public involvement coordinators training
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Patient and public involvement coordinators deliver Research Awareness Training to RUGs using a two-way flow interactive discussion. Two-way flow interactive discussion involves an exchange of ideas where both facilitator and RUG members are active and can prompt one another in the discussion of a particular research topic. Each Research Awareness Training session lasts around 60 min. Each training session is delivered to support and complement RUG members’ involvement in specific aspects of SENSE-Cog research on a needs basis. For example, Research Awareness Training on qualitative methods is offered immediately prior to the RUGs reviewing a question related to qualitative aspects of SENSE-Cog research.

Measures

Quantitative and qualitative methods will be used to evaluate the experience of Research Awareness Training for RUG members.

Training Acceptability Rating Scale (TARS) [25].

The TARS [25] was selected for evaluating the training, as the TARS has previously been used to evaluate Research Awareness Training for patient and public involvement volunteers [26, 27]. The TARS is a self-administered paper questionnaire and takes approximately 5–10 min to complete. The TARS consists of three parts: the first concentrating on appropriateness and acceptability of the training, the second covering effectiveness and competency of the trainers. The first two parts contain items rated on a four-point Likert scale, ranging from ‘Not at all’ (score 1) to ‘A great deal’ (score 4). The third and final part includes three open ended questions for RUG members to identify the most useful elements of the training, suggest changes and add additional comments. The Research Awareness Training materials and TARS was translated into Greek and French using the ‘forward-translations and back-translations’ procedure [28].

Semi structured interview and focus group interview.

RUG members who have completed the Research Awareness Training will be approached to take part in a semi-structured interview [see Additional file 2] or focus group interview [see Additional file 3] to give their impressions of the training overall, indicate what insights, understanding and skills they had acquired and how they have applied the knowledge and skills provided by the training within the SENSE-Cog programme.

Procedure

Training sessions will be carried out approximately every 3 months. There is some flexibility in the scheduling of training delivery according to local requirements. For example, one training session in Cyprus was postponed from July to September due to very hot summer weather. Participants will complete the TARS questionnaire at the end of each training session to ensure that those with cognitive or memory impairment can provide immediate feedback for each training session. The semi-structured interview will be conducted once participants have completed all 6 training sessions in order to obtain each RUG members’ overall impressions of training.

Perceived impacts of the involvement of older people with dementia on the research from the point of view of RUG members and researchers

Sample

Twenty-four one to one interviews with RUG members (6 at each site) and 6 one to one interviews with SENSE-Cog researchers will be conducted across all sites. The final sample size will be determined by data saturation [29,30,31], although we anticipate that a sample of approximately 6 interviews will be required.

Additional focus group interviews to capture RUG members’ views on the on-going RAT and their experience as a RUG member and their perceived impact on the research process, will allow us to reflect on our programme’s progress towards achieving its objectives and make any changes on an on-going basis, such as change of venue or working approach with the RUG members. We will aim to maximise diversity in the study sample to increase the validity and transferability of research findings to other settings. The sample of RUG members will include (i) men and women ages 65 years and above (ii) older people with dementia (iii) older people with dementia and age-related hearing and/or vision impairment (iv) carers with age related hearing and/ or vision impairment. RUG membership was constrained to include only people over the age of 65 due to the focus on older adults in the SENSE-Cog project. Younger people with dementia and younger carers will not therefore be included in the research evaluation. The sample of researchers will include i) researchers at different levels (i.e. work package leads and research assistants), ii) researchers in different SENSE-Cog work packages (see Fig. 1) who have worked with the RUGs and iii) different countries.

Measures

One to one semi structured interviews and focus group interviews will be conducted with RUG members by the patient and public involvement coordinators in each site to capture RUG members’ impression of the training and of their experience as a RUG member and their perceived impact on the research process. One to one semi structured interviews with SENSE-Cog researchers [see Additional file 4] across all sites will be conducted by the project coordinator based in Manchester to assess SENSE-Cog researchers experience of working with RUGs and the impacts that RUGs have had on the research process.

Procedure

Eight focus group interviews will be conducted in total with RUG members (2 focus groups in each RUG site). Focus group interviews will take place at approximately 22 months and 37 months following the commencement of RUG activities. These time points were selected in order to record RUG members’ impressions at the approximate mid-point and near the end of involvement in the research to capture people’s views and opinions during on-going involvement in research. In addition, we chose to collect focus group data at more than one point due to the age of RUG members and the progressive nature of dementia. RUG participants may drop in or out of involvement if their condition fluctuates or if RUG members can no longer provide on-going informed consent to participate in the research evaluation of their involvement. One to one interviews with RUG members will be conducted at approximately 34 months. Similarly.

One to one interviews with SENSE-Cog researchers will be conducted at approximately 34 months in order to capture researcher’s perceptions of RUG involvement near the end of the research program.

Data analysis

TARS [25] data will be analysed at group level using SPSS (IBM, Armonk, NY, United States) to generate descriptive statistics. The open ended questions from the TARS will be analysed qualitatively, as for the interview data below.

One to one interviews and focus group interviews will be audio-recorded. Audio-recordings in Nice, Nicosia and Athens will be transcribed verbatim in the local languages and then translated by each local patient and public involvement coordinator. The data from all 4 sites will be analysed by the lead Study Coordinator in Manchester using NVIVO qualitative software (QSR International Pty Ltd., Victoria, Australia). The FRAMEWORK method [32] will be used for data analysis. The FRAMEWORK method allows in-depth analysis of key themes across the whole datasets, as well as between individual accounts; as it uses existing topic guide as a starting point for the framework, whereas other thematic approaches may just generate themes directly from the data. In addition, the framework method allows the summaries of data across each case and theme or subtheme into charts using Excel which makes the data accessible to a wider research team.

Data from interviews from each site will firstly be analysed separately to produce themes that are relevant to each site. Coding that is conceptually and characteristically noteworthy will be highlighted, rather than focusing just on frequency of occurrence [32, 33]. After separate analysis of interview data for each site, themes identified in separate analyses for each site will then be evaluated for common themes across all sites, as well as identification of distinct issues between sites. Analysis across sites will involve a systematic approach for the patient and public involvement coordinators in each sites to refine the themes, classify them into categories and draw conclusions about differences between sites.

The format of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) [34] reporting checklists will be used to report the implementation and evaluation of patient and public involvement in this study and we will share our findings on the evaluation of the Research Awareness Training via peer reviewed publication once it is complete.

Ethics

The study received ethical approval from Manchester University Research Ethics Committee. Additional ethical approvals were sought and obtained for each study site (Nicosia, Nice, Athens), as relevant to local arrangements.

A key ethical issue when working with people with dementia is informed consent, especially how researchers establish whether people have capacity for informed consent and how any changes in capacity are identified. According to the Mental Capacity Act (2005) [35], people should be assumed to have capacity unless otherwise demonstrated. The capacity of participants with cognitive impairment to consent to participate (provided that they have clear and appropriate study information and enough time to make decisions) will be assessed on an on-going basis. All staff members involved in this research completed training in assessing capacity in research.

To support the informed participation in the research, RUG members provided input into the development of easy access user friendly versions of the participant information sheet and consent form [see Additional file 5]. In cases where RUG members are unable to complete the consent form due to low vision, the consent form is read out verbatim. RUG member may then agree verbally to participate, and the patient and public involvement coordinator signs the consent form on behalf of the RUG member, which is then witnessed and countersigned by another SENSE-Cog project researcher.

The patient and public involvement coordinators at each site contact the RUG members via telephone 2 weeks before each training session to establish their capacity to consent, and their understanding of their involvement in the training and the evaluation study. The patient and public involvement coordinator assesses whether RUG members can retain the information discussed with them over telephone or in person at the time of discussion by asking the RUG member to repeat the information explained to them. Pre-meetings take place before each training session or RUG meeting to give the patient and public involvement coordinator the opportunity to speak with the participant again to establish their capacity for consent and involvement. A similar approach will be taken prior to the one to one interviews and focus group interviews with RUG members.

Discussion

Dementia research is an international priority. To ensure the relevance of research outcomes to older people with dementia, it is vital the views of older people with dementia are taken into account when designing research [2, 3, 6,7,8]. There is a small but growing literature on the methodology and impacts of involving people with dementia in dementia research [7, 36]. Previous reviews of PPI in health research have recognised a lack of reporting of the impact and benefits of PPI, and where studies have described the impact of PPI, the quality of the evidence is low [37,38,39,40]. The lack of good quality research on the impacts and benefits of PPI necessitates the need for evidence-based models of good practice of patient and public involvement in health research in general as well as evidence for the impacts and benefits of involvement [37,38,39,41]. The need is particularly acute in the case of involving older people with dementia and age-related hearing and/or vision impairment in health research. Very few studies have described and evaluated patient and public involvement with older people with dementia [7, 19, 21, 36, 42,43,44].

In the present study, we made particular methodological choices to facilitate the participation of older people with dementia and age-related hearing and/or vision impairment in the research evaluation of Research Awareness Training and the impact of RUGs on the SENSE-Cog research project. We chose a combination of questionnaires, focus groups and one to one interviews, because people with dementia have previously participated in research to investigate their opinions and feelings through the use of questionnaires, focus groups and one to one interviews [44,45,46,47,48]. We also employed procedures that maximise participation of people with dementia in research [6, 49,50,51,52]. For example, questionnaires were completed by RUG members at the end of each training session, minimising the demand on memory to recall past experiences with training. Completing the questionnaires after each training session also allowed participants to ask for clarification from the patient and public involvement coordinators if they required it. We took a flexible approach for the first sets of focus group interviews, based on whether or not the participant wanted to contribute in the group discussion on the day, with quiet rooms available for rest breaks.

Similarly one to one interviews enable the interviewer to explore opinions in-depth, pick up on non-verbal interactions, check the comprehension of questions and allow participants to take time to reflect and respond [48, 49, 51]. We are aware that people with dementia may not be able to participate in interviews of long duration [53]. We therefore have planned to take a flexible approach and conduct interviews based on whether or not the RUG participant wants to complete the interview on the day. We will attempt to minimise the overall time of the interview and/or plan in regular breaks during the interviews with quiet rooms available to offer opportunities for rest breaks. The patient and public involvement coordinators will conduct the one to one interviews, as they have an established relationship with RUG members and are aware of the needs and style of communication for each member. Patient and public involvement coordinators will plan in extra time before and after the interview to help make the participant feel comfortable [6, 49].

This protocol sets out to evaluate training to support the involvement of older people with dementia and age-related hearing and/or vision impairment and the impact of their involvement in research. Evaluation of the RAT will help us to understand the acceptability and appropriateness of the training, findings will be published to contribute to advancing the knowledge base of research training methods for involvement in general and for this particular population group in particular. The study will facilitate better understanding of best practice for the involvement of older people with dementia and age-related hearing and/or vision impairment in research.