Background: It is important to evaluate fidelity of delivery and engagement during feasibility trials. However, there is little guidance on how to systematically develop strategies to improve implementation if problems arise. We aimed to: 1) Assess fidelity of delivery and engagement, 2) Identify factors influencing fidelity of delivery and engagement, and 3) Develop strategies to improve fidelity of delivery of, and engagement with, a complex intervention to improve independence in dementia, within a feasibility trial. Methods: A mixed methods evaluation of an intervention that aimed to improve independence in dementia. To assess fidelity of delivery and engagement, observation and self-report methods were used: 60% of audio-recorded intervention sessions were transcribed and reliably rated for fidelity. Providers (n = 12) and people with dementia/ supporters (n = 34) were asked to complete checklists after each session. Descriptive statistics were used to analyse the data. To identify factors influencing fidelity and engagement, one-to-one semi-structured interviews were conducted with providers (n = 8), people with dementia (n = 7) and supporters (n = 7). Thematic analysis and content analysis were used to analyse data. To develop strategies, we followed four steps proposed by the authors of the Behaviour Change Wheel (1. Understanding the behaviour, 2. Identifying intervention functions, 3. Specifying intervention content, 4. Identifying mode of delivery).

1 Objective: The objectives of this systematic review were to: 1) understand how people 2 living with dementia are involved in making decisions; 2) explore the different 3 decisional styles and domains of decision-making that people living with dementia 4 experience and 3) identify what influences the level of decisional involvement of 5 people living with dementia.6 Methods: A systematic review of literature identified studies from Medline, PsycINFO, 7 HAPI and CINAHL databases. Search terms related to decision-making and dementia. 8 Qualitative and quantitative research designs were included. Appraisal of included 9 studies was done using quality ratings. All studies focused on how decision-making 10 took place. Extracted findings were synthesised narratively with concept mapping, 11 conceptualisation and an exploration of connections between studies to develop an 12 overall model of decision-making involvement 13 Results: Fifteen studies fully met the eligibility criteria (thirteen qualitative and two 14 quantitative). All studies had moderate (n=10) to high (n=5) quality ratings. 15 Participants were predominantly people living with dementia (n=13), Parkinson's 16 disease and stroke. The model of decision-making encompasses four decisional styles 17 (managed autonomy, and delegated) determined by different degrees of involvement 18 from the person living with dementia and their supporter. The decisional style 19 implemented is influenced by the presence or absence of background (the Freedom of 20 Choice framework) and contextual factors (risk, relationships and resources).21 Conclusion: Decision-making in dementia is complex and influenced by many factors 22 beyond cognitive impairment alone. This review indicates that decision-making in 23 dementia takes place through decisional styles, determined by unique levels of 24 involvement from people living with dementia and their carers.25

Background A diagnosis of dementia presents individuals with both social and psychological challenges but research on self-stigma in dementia has been largely confined to qualitative approaches due to a lack of robust outcome measures that assess change. The Stigma Impact Scale (SIS) is the most commonly used measure of self-stigma in dementia but its suitability as a tool to assess change in a UK population is unclear. Thus, the aim of this study was to identify, adapt and evaluate the acceptability and preliminary psychometric properties of self-stigma measures for people with dementia for use as measures of change. Method A 4-step sequential design of identifying, selecting, adapting and testing psychometric measures as follows: 1) identification of stigma outcome measures through reviewing anti-stigma intervention literature, 2) selection of candidate measures through quality assessment (Terwee criteria) and expert consultation, 3) adaptation for UK dementia population (Stewart and colleagues Modification Framework) 4) testing of adapted measures in people living with dementia (N=40) to establish acceptability and preliminary reproducibility (test retest), criterion (concurrent with SIS) and construct (negative convergence with Rosenberg self-esteem scale) validity. Results Seven measures were identified from the review, but most were poor quality (Terwee range: 0–4). Three measures were selected for modification: Stigma Stress Scale; Secrecy subscale of the Stigma Coping Orientation Scale; Disclosure Related Distress Scale. Internal consistency and test-retest reliability were acceptable (.866≤α≤ .938; ICC .721–.774), except for the Stigma Stress Scale (α= .643) for which the component subscales (perceived harm, ability to cope) had stronger psychometric properties. Concurrent validity with the SIS was not established (r<.7) although there were significant correlations between total SIS and perceived harm (r=.587) and between internalized shame and secrecy (r=.488). Relationships with self-esteem were in the hypothesized direction for all scales and subscales indicating convergent validity. Conclusion Stigma scales from mental health are not readily adapted for use with people with dementia. However there is preliminary evidence for the acceptability, reliability and validity of measures of perceived harm, secrecy and stigma impact. Further conceptual and psychometric development is required.

This study describes the adaptation of Honest, Open, Proud (HOP), to develop an empowerment intervention supporting disclosure decision-making for dyads of people living with dementia and their chosen supporter. Methods: Medical Research Council guidelines for developing complex interventions informed intervention development and feasibility testing. This included identifying the evidence base and theory (establishing HOP theory of change, a systematic review on decision-making in dementia, a stakeholder consultation), modelling the intervention materials with research experts (creation of version 1.0) and experts by experience (creation of version 2.0), and pilot testing the intervention recording participant observations and facilitator reflections. The final version of the intervention materials was developed with experts by experience of dementia where the accessibility of language and appropriate styles of facilitation were the focus. Results: The concept of the intervention was strongly endorsed by respondents of the stakeholder consultation (209/226). Stakeholder preferences included face-to-face delivery, a manualized workbook approach and the inclusion of the primary carer during intervention delivery. Recruitment for intervention groups took place in non-NHS settings (2 small groups recruited) and NHS settings (no groups recruited). In non-NHS settings, 7 dyads agreed to take part in one of two intervention groups. Both intervention groups had over 70% attendance by participants (group 1: 72.2% group 2: 87.5%). Conclusion: The concept of an intervention to support diagnostic disclosure was endorsed by stakeholders; however, recruitment was challenging; the "who to tell, how and when?" intervention has the potential to fill a gap in the post-diagnostic pathway.

Background: A diagnosis of dementia presents individuals with both social and psychological challenges but research on self-stigma in dementia has been largely confined to qualitative approaches due to a lack of robust outcome measures that assess change. The Stigma Impact Scale is the most commonly used measure of self-stigma in dementia but its suitability as a tool to assess change in a diverse UK population is unclear. Thus, the aim of this study was to identify, adapt and evaluate the acceptability and psychometric properties of self-stigma measures for people with dementia for use as measures of change. Method: A four-stage approach was used to identify, adapt and test self-stigma measures in a UK population who had received a diagnosis of dementia: 1) psychometric outcome measures were extracted based on the evidence base of an anti-stigma intervention that guided the current work, 2) identified measures were assessed for psychometric quality according to Terwee criteria, 3) modifications were made for culture (UK) and condition (dementia rather than mental health) through stakeholder consultations (researchers in fields of dementia and stigma; experts by experience in living with, or caring for persons with dementia), and 4) modified measures were pilot tested in a small sample of people living with dementia (N=40) for acceptability, and preliminary psychometric properties (internal consistency, test-retest, concurrent and convergent validity). Results: Seven measures were identified but most were of low quality (Terwee range: 0-4). Three measures were considered and modifiable by stakeholders. Pilot testing indicated data were normally distributed. Almost all measures demonstrated acceptable internal consistency (except the Stigma Stress Scale total and internalized shame subscale), test retest reliability, concurrent validity and convergent validity, with some exceptions. Conclusion: The Secrecy subscale, Stigma Impact Scale and Stigma Stress Scale were acceptable for use in a UK population of people living with dementia. However, further psychometric analysis is required before such measures can be implemented in psychosocial research.