The unrecognized role of fidelity in effectiveness-implementation hybrid trials: simulation study and guidance for implementation researchers.

BACKGROUND: Effectiveness-implementation hybrid designs are a relatively new approach to evaluate efficacious interventions in real-world settings while concurrently gathering information on the implementation. Intervention fidelity can significantly influence the effectiveness of an intervention during implementation. However little guidance exists for applied researchers conducting effectiveness-implementation hybrid trials regarding the impact of fidelity on intervention effects and power. METHODS: We conducted a simulation study based on parameters from a clinical example study. For the simulation, we explored parallel and stepped-wedge cluster randomized trials (CRTs) and hypothetical patterns of fidelity increase during implementation: slow, linear, and fast. Based on fixed design parameters, i.e., the number of clusters (C = 6), time points (T = 7), and patients per cluster (n = 10) we used linear mixed models to estimate the intervention effect and calculated the power for different fidelity patterns. Further, we conducted a sensitivity analysis to compare outcomes based on different assumptions for the intracluster-correlation coefficient and the cluster size. RESULTS: Ensuring high fidelity from the beginning is central to achieve accurate intervention effect estimates in stepped-wedge and parallel CRTs. The importance of high fidelity in the earlier stages is more emphasized in stepped-wedge designs than in parallel CRTs. In contrast, if the increase of fidelity is too slow despite relatively high starting levels, the study will likely be underpowered and the intervention effect estimates will also be biased. This effect is more accentuated in parallel CRTs, here reaching 100% fidelity within the next measurement points is crucial. CONCLUSIONS: This study discusses the importance of intervention fidelity for the study`s power and highlights different recommendations to deal with low fidelity in parallel and stepped-wedge CRTs from a design perspective. Applied researchers should consider the detrimental effect of low fidelity in their evaluation design. Overall, there are fewer options to adjust the trial design after the fact in parallel CRT as compared to stepped-wedge CRTs. Particular emphasis should be placed on the selection of contextually relevant implementation strategies.

[Prevalence of neuropsychiatric symptoms of people with dementia in long-term care units: A secondary analysis]. / Prävalenz von neuropsychiatrischen Symptomen bei Menschen mit Demenz in der stationären Langzeitpflege.

Prevalence of neuropsychiatric symptoms of people with dementia in long-term care units: A secondary analysis Abstract: Background: In a progress of dementia, most people develop neuropsychiatric symptoms. However, there is little knowledge about the prevalence of these symptoms and their specific characteristics in long-term care. Aims: A differentiated investigation of the prevalence and characteristics of neuropsychiatric symptoms in people with dementia in a long-term care setting. Methods: The prevalence of neuropsychiatric symptoms of people with dementia in a long-term care setting was examined using a secondary analysis of cross-sectional data from the research projects LebenQD I and II and FallDem. The data were collected using the neuropsychiatric inventory - nursing home version. The analysis included data from 699 people with dementia from a total of 21 long-term care facilities in North Rhine-Westphalia. Results: The symptoms agitation/aggression (36%), depression/dysphoria (33%), apathy/indifference (33%), irritability/lability (30%) and aberrant motor behaviour show the highest prevalence. The symptoms hallucinations (9%) and euphoria/elation (6%) have the lowest prevalence. Conclusions: The high prevalence of specific neuropsychiatric symptoms and their characteristics in people with dementia illustrates the need for care-related or psychosocial interventions to counteract the reasons for the occurrence of the symptoms.

Relationship between the severity of agitation and quality of life in residents with dementia living in German nursing homes - a secondary data analysis.

BACKGROUND: Severe agitation and its relation to single dimensions of quality of life are not well understood. The aim of this study was to gain more knowledge about severe agitation and to examine the relationships between the severity of agitation and single dimensions of quality of life among residents with dementia living in German nursing homes. METHODS: This exploratory secondary analysis included data from 1947 residents of 66 German nursing homes from the DemenzMonitor study. The construct of agitation was defined as a composite score of the items agitation/aggression, irritability/lability and disinhibition from the Neuropsychiatric Inventory Questionnaire (NPI-Q); the resident was classified as severely agitated if at least one of these symptoms was rated as 'severe'. The single dimensions of quality of life were measured with the short version of the QUALIDEM instrument. To avoid selection bias, two controls with mild or no agitation were selected for each resident with severe agitation using propensity score matching. Mixed linear regression models were then generated to determine the differences in the dimensions of quality of life for the severity of agitation and the defining items. RESULTS: For four out of five dimensions of quality of life of the short version of QUALIDEM, residents with severe agitation had significantly lower values than residents without severe agitation. Converted to scale size, the greatest difference between both groups was found in the dimension social isolation with 23.0% (-2.07 (95% CI: -2.57, -1.57)). Further differences were found in the dimensions restless tense behaviour with 16.9% (-1.52 (95% CI: -2.04, -1.00)), positive affect with 14.0% (-1.68 (95% CI: -2.28, -1.09)) and social relations with 12.4% (-1.12 (95% CI: -1.54, -0.71)). CONCLUSIONS: Severe agitation is a relevant phenomenon among nursing home residents with dementia and is associated with lower values of quality of life in the dimensions social isolation, restless tense behaviour, positive affect and social relations from the QUALIDEM instrument. Therefore, more attention should be paid to severe agitation in nursing practice and research. Moreover, care strategies used to reduce severe agitation should be considered in terms of their impact on the dimensions of quality of life.

Process evaluation of the response of nursing homes to the implementation of the dementia-specific case conference concept WELCOME-IdA: A qualitative study.

BACKGROUND: The implementation of clearly structured dementia-specific case conferences could be an important tool to enable nursing staff to properly analyse and manage challenging behaviour in nursing home residents with dementia. A process evaluation of the responses of nursing homes to the implementation of WELCOME-IdA (Wittener model of case conferences for people with dementia - the Innovative dementia-oriented Assessment tool) was carried out to gain insight into which key elements of the intervention were adopted by the nursing homes and which elements were adapted. METHODS: This study was part of a larger process evaluation using a qualitative design. Thirty-four semi-structured telephone interviews and 15 focus group interviews were conducted in four nursing homes. The interviews were analysed using deductive content analysis, although inductive categories have been developed. RESULTS: Nursing home staff adopted the roles of moderator, case reporter, keeper of the minutes and reflection partner in WELCOME-IdA, but the selection of the staff members who filled these roles differed across nursing homes. The recommended group size of 5-8 participants per case conference was sometimes adopted. The key element of having core nursing teams who participated continuously in all case conferences was not adopted at all. Instead, there was a high level of rotation among staff members. The pre-defined process structure of WELCOME-IdA was adapted in such a way that the assessment of the residents' behaviour and the selection of the relevant domain for the behaviour analysis were conducted in advance of the case conference. The evaluation of the interventions was also organized differently. CONCLUSION: The scope of the response implies that WELCOME-IdA requires further adaptation to the requirements of nursing processes in nursing homes. The results provide important information on the selection of role keepers and offer insights into a) how knowledge of the structured training was circulated and transformed into self-organized case conferences and b) how knowledge was circulated throughout the entire processing of one case. Thus, these results can be used to optimize intervention and implementation. Overall, the intervention should allow more possibilities for tailored adaptation than it currently does.

Interne Konsistenz und Konstruktvalidität des demenzspezifischen Lebensqualitätsinstruments QUALIDEM - Eine Sekundärdatenanalyse einer Querschnittserhebung.

Internal consistency and construct validity of the Quality of Life measurement in dementia QUALIDEM - a secondary data analysis of cross-sectional data Abstract. Background: Maintaining and improving the Quality of Life (QoL) of people with dementia is the principal aim of nursing and medical care. The QUALIDEM is a theory-based, dementia-specific QoL instrument in the German language. Until now, however, there are hardly any findings on the construct validity. OBJECTIVE: Evaluation of the item difficulty, internal consistency, discriminant and convergent validity of the German QUALIDEM. METHOD: The evaluation of the construct validity is based on a Multi-Trait-One-Method approach, using a sample of 167 people with mild to severe dementia and 71 people with very severe dementia. RESULTS: The correlation between the QUALIDEM subscales and the comparative constructs agitation, depression, anxiety, aberrant motoric behavior, apathy, pain and QoL, measured with the Alzheimer's Disease Related Quality of Life instrument, was confirmed in the expected direction in 82 % of the predefined hypotheses. The correlation coefficients range between 0.04 and -0.60 (discriminant validity) and -0.21 and 0.71 (convergent validity). For the majority of QUALIDEM subscales a good internal consistency could be demonstrated. CONCLUSION: The results indicate first indications for the construct validity of the QUALIDEM subscales and for the further development of the instrument. In future studies, the validity of the German QUALIDEM should be further investigated.

Development and evaluation of the content validity, practicability and feasibility of the Innovative dementia-oriented Assessment system for challenging behaviour in residents with dementia.

BACKGROUND: One of the most difficult issues for care staff is the manifestation of challenging behaviour among residents with dementia. The first step in managing this type of behaviour is analysing its triggers. A structured assessment instrument can facilitate this process and may improve carers' management of the situation. This paper describes the development of an instrument designed for this purpose and an evaluation of its content validity and its feasibility and practicability in nursing homes. METHODS: The development process and evaluation of the content validity were based on Lynn's methodology (1998). A literature review (steps 1 + 2) provided the theoretical framework for the instrument and for item formation. Ten experts (step 3) evaluated the first version of the instrument (the Innovative dementia-oriented Assessment (IdA®)) regarding its relevance, clarity, meaningfulness and completeness; content validity indices at the scale-level (S-CVI) and item-level (I-CVI) were calculated. Health care workers (step 4) evaluated the second version in a workshop. Finally, the instrument was introduced to 17 units in 11 nursing homes in a field study (step 5), and 60 care staff members assessed its practicability and feasibility. RESULTS: The IdA® used the need-driven dementia-compromised behaviour (NDB) model as a theoretical framework. The literature review and expert-based panel supported the content validity of the IdA®. At the item level, 77% of the ratings had a CVI greater than or equal to 0.78. The majority of the question-ratings (84%, n = 154) and answer-ratings (69%, n = 122) showed valid results, with none below 0.50. The health care workers confirmed the understandability, completeness and plausibility of the IdA®. Steps 3 and 4 led to further item clarification. The carers in the study considered the instrument helpful for reflecting challenging behaviour and beneficial for the care of residents with dementia. Negative ratings referred to the time required and the lack of effect on residents´ behaviour. CONCLUSIONS: There was strong evidence supporting the content validity of the IdA®. Despite the substantial length and time requirement, the instrument was considered helpful for analysing challenging behaviour. Thus, further research on the psychometric qualities, implementation aspects and effectiveness of the IdA® in understanding challenging behaviour is needed.

Individualized formulation-led interventions for analyzing and managing challenging behavior of people with dementia - an integrative review.

OBJECTIVE: Individualized formulation-led interventions offer a promising approach for analyzing and managing challenging behaviors in people with dementia. Little is known about which individualized formulation-led interventions exist and what effects these interventions have on people with dementia and their caregivers. Therefore, the review aims to describe and examine existing interventions and to review their evidence. METHODS: An integrative review of individualized formulation-led interventions for managing challenging behavior in people with dementia was conducted. PUBMED, PsycINFO [EBSCO] and CINAHL [EBSCO] databases were searched between February and April 2014 using key terms related to dementia, challenging behavior and individualized formulation- led interventions. The literature search was limited to German and English publications published from 1995. No limitations were placed on the type of paper, type of study design and stage of disease or setting. 37 relevant papers that met the inclusion criteria were included in this review. RESULTS: The literature review provided 14 different individualized formulation-led interventions. The effects on people with dementia were diverse, as only half of the studies showed a significant reduction in behaviors compared with the control group. Family caregivers felt less upset about the challenging behavior and more confident in their ability to manage the behavior. CONCLUSION: There is a clear need for further research on individualized formulation-led interventions. The results of this review have the potential for developing interventions and for designing methodological robust evaluation studies that take into account the effectiveness of individualized formulation-led interventions on patient and caregiver outcomes.

PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial.

BACKGROUND: Demographic changes, with an increasing number and proportion of older people with multimorbidity and frailty, will put more pressure on home care services in municipalities. Frail multimorbid people receiving home care services are at high risk of developing crises, defined as critical challenges and symptoms, which demand immediate and new actions. The crises often result in adverse events, coercive measures, and acute institutionalisation. There is a lack of evidence-based interventions to prevent and resolve crises in community settings. METHODS: This is a participatory action research design (PAR) in a 6-month cluster randomised controlled trial (RCT). The trial will be conducted in 30 municipalities, including 150 frail community-dwelling participants receiving home care services judged by the services to be at risk of developing crisis. Each municipality (cluster) will be randomised to receive either the locally adapted TIME intervention (the intervention group) or care as usual (the control group). The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) is a manual-based, multicomponent programme that includes a rigorous assessment of the crisis, one or more interdisciplinary case conferences, and the testing and evaluation of customised treatment measures. PAR in combination with an RCT will enhance adaptations of the intervention to the local context and needs. The primary outcome is as follows: difference in change between the intervention and control groups in individual goal achievement to resolve or reduce the challenges of the crises between baseline and 3 months using the PRACTIC Goal Setting Interview (PGSI). Among the secondary outcomes are the difference in change in the PGSI scale at 6 months and in neuropsychiatric symptoms (NPSs), quality of life, distress perceived by professional carers and next of kin, and institutionalisation at 3 and 6 months. DISCUSSION: Through customised interventions that involve patients, the next of kin, the social context, and health care services, crises may be prevented and resolved. The PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC) study will enhance innovation for health professionals, management, and users in the development of new knowledge and a new adapted approach towards crises. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05651659. Registered 15.12.22.

TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) Project: Protocol for an International Longitudinal Multicenter Study.

BACKGROUND: Nursing-sensitive events (NSEs) are common, accounting for up to 77% of adverse events in hospitalized patients (eg, fall-related harm, pressure ulcers, and health care-associated infections). NSEs lead to adverse patient outcomes and impose an economic burden on hospitals due to increased medical costs through a prolonged hospital stay and additional medical procedures. To reduce NSEs and ensure high-quality nursing care, appropriate nurse staffing levels are needed. Although the link between nurse staffing and NSEs has been described in many studies, appropriate nurse staffing levels are lacking. Existing studies describe constant staffing exposure at the unit or hospital level without assessing patient-level exposure to nurse staffing during the hospital stay. Few studies have assessed nurse staffing and patient outcomes using a single-center longitudinal design, with limited generalizability. There is a need for multicenter longitudinal studies with improved potential for generalizing the association between individual nurse staffing levels and NSEs. OBJECTIVE: This study aimed (1) to determine the prevalence, preventability, type, and severity of NSEs; (2) to describe individual patient-level nurse staffing exposure across hospitals; (3) to assess the effect of nurse staffing on NSEs in patients; and (4) to identify thresholds of safe nurse staffing levels and test them against NSEs in hospitalized patients. METHODS: This international multicenter study uses a longitudinal and observational research design; it involves 4 countries (Switzerland, Sweden, Germany, and Iran), with participation from 14 hospitals and 61 medical, surgery, and mixed units. The 16-week observation period will collect NSEs using systematic retrospective record reviews. A total of 3680 patient admissions will be reviewed, with 60 randomly selected admissions per unit. To be included, patients must have been hospitalized for at least 48 hours. Nurse staffing data (ie, the number of nurses and their education level) will be collected daily for each shift to assess the association between NSEs and individual nurse staffing levels. Additionally, hospital data (ie, type, teaching status, and ownership) and unit data (ie, service line and number of beds) will be collected. RESULTS: As of January 2024, the verification process for the plausibility and comprehensibility of patients' and nurse staffing data is underway across all 4 countries. Data analyses are planned to be completed by spring 2024, with the first results expected to be published in late 2024. CONCLUSIONS: This study will provide comprehensive information on NSEs, including their prevalence, preventability, type, and severity, across countries. Moreover, it seeks to enhance understanding of NSE mechanisms and the potential impact of nurse staffing on these events. We will evaluate within- and between-hospital variability to identify productive strategies to ensure safe nurse staffing levels, thereby reducing NSEs in hospitalized patients. The TAILR (Nursing-Sensitive Events and Their Association With Individual Nurse Staffing Levels) study will focus on the optimization of scarce staffing resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56262.

Scalability and internal consistency of the German version of the dementia-specific quality of life instrument QUALIDEM in nursing homes - a secondary data analysis.

BACKGROUND: Quality of life (Qol) is a widely selected outcome in intervention studies. The QUALIDEM is a dementia-specific Qol-instrument from The Netherlands. The aim of this study is to evaluate the scalability and internal consistency of the German version of the QUALIDEM. METHODS: This secondary data analysis is based on a total sample of 634 residents with dementia from 43 nursing homes. The QUALIDEM consists of nine subscales that were applied to a subsample of 378 people with mild to severe dementia and six consecutive subscales that were applied to a subsample of 256 people with very severe dementia. Scalability, internal consistency and distribution scores were calculated for each predefined subscale using the Mokken scale analysis. RESULTS: In people with mild to severe dementia, seven subscales, care relationship, positive affect, negative affect, restless tense behavior, positive self-image, social relations and feeling at home, were scalable (0.31 ≤ H ≤ 0.65) and internally consistent (Rho ≥ 0.62). The subscales social isolation (H = 0.28) and having something to do (H = 0.18) were not scalable and exhibited insufficient reliability scores (Rho ≤ 0.53). For people with very severe dementia, five subscales, care relationship, positive affect, restless tense behavior, negative affect and social relations, were scalable (0.33 ≤ H ≤ 0.65), but only the first three of these subscales showed acceptable internal consistency (Rho 0.59 - 0.86). The subscale social isolation was not scalable (H = 0.20) and exhibited poor internal consistency (Rho = 0.42). CONCLUSIONS: The results show an acceptable scalability and internal consistency for seven QUALIDEM subscales for people with mild to severe dementia and three subscales for people with very severe dementia. The subscales having something to do (mild to severe dementia), negative affect (very severe dementia), social relations (very severe dementia) and social isolation (both versions) produced unsatisfactory results and require revision.

Case conferences as interventions dealing with the challenging behavior of people with dementia in nursing homes: a systematic review.

BACKGROUND: Challenging behaviors such as aggression, screaming, and apathy are often encountered when caring for people with dementia in nursing homes. In this context, a case conference is often recommended for healthcare professionals as an effective instrument to improve the quality of care. However, the subject case conference has not had great consideration in scientific literature. The aim of this review is to describe the effects of case conferences on people with dementia and challenging behavior and the staff in nursing homes. METHODS: A search of intervention studies in nursing homes in the German or English language was performed in the following databases: Medline, Cinahl, PsycINFO, Cochrane library, Embase, and Google Scholar. The selection and the methodological quality of the studies were assessed independently by two authors. The results were summarized and compared based on categories such as study quality or outcomes. RESULTS: Seven of 432 studies were included in the review. A total of four of seven studies showed a reduction in the challenging behavior of people with dementia, and five showed an influence on the competence, attitudes, and job satisfaction of the staff. However, due to the middle-range quality of several studies, the methodological heterogeneity and differences in the interventions, the results must be interpreted with caution. CONCLUSIONS: In summary, little evidence exists for the positive effects of case conferences in the care of people with dementia. This review highlights the need for methodologically well-designed intervention studies to provide conclusive evidence of the effects of case conferences.

[The influence of understanding diagnostics on perceived stress of nurses caring for nursing home residents with dementia]. / Die Auswirkungen der Verstehenden Diagnostik auf das Belastungserleben Pflegender im Umgang mit Menschen mit Demenz in der stationären Altenhilfe.

Health services for nursing home residents with dementia require the expertise of highly trained nursing staff. In addition, dealing with challenging behaviour of people with dementia is often stressful for nurses and causes major difficulties for them. Being a part of the general nursing guidelines, «understanding diagnostics¼ enables nursing staff to deal with challenging behaviour of persons with dementia. The primary focus of the concept is to understand the behaviour. The aim of the study was to implement and evaluate «understanding diagnostics¼ through structured case conferences and the application of the 'Innovative dementia-oriented Assessment system' (IdA) in nursing homes for the first time. Nursing staff of 15 nursing homes in North- Rhine Westphalia were trained about the content and implementation of «understanding diagnostics¼. Nurses' perceived level of stress was measured before (n = 106) and after (n = 71) the intervention (9 months). The study results show positive effects on the nurses' perceived level of stress. They support the use of structured case conferences and the IdA assessment in order to understand the behaviour of nursing residents with dementia. The implementation of «understanding diagnostics¼ allows nursing staff to deal with challenging behaviour of nursing home residents with dementia.

Types of implementation of the dementia-specific case conference concept WELCOME-IdA in nursing homes: a qualitative process evaluation of the FallDem effectiveness trial.

BACKGROUND: Dementia is regularly associated with behavioral and psychological symptoms of dementia (BPSD, also referred to as challenging behavior). Structured dementia-specific case conferences (DSCCs) enable nursing staff in nursing homes (NHs) to analyze and handle the BPSD of residents with dementia. The FallDem trial estimated the effectiveness of the structured DSCC intervention WELCOME-IdA (Wittener model of case conferences for people with dementia - the Innovative dementia-oriented Assessment tool) in NHs in Germany. No significant change in the overall prevalence of challenging behavior was found. A multipart process evaluation was conducted to explain this result. METHODS: This qualitative process evaluation of the response of individuals, perceived maintenance, effectiveness, and unintended consequences was part of the multipart process evaluation that followed the framework by Grant et al. (Trials 14: 15, 2013). It used the data from semi-structured telephone interviews and focus group interviews with nurses and managers as secondary data. Selected domains of the Consolidated Framework for Implementation Research (CFIR) were used as deductive categories for a directed content analysis. RESULTS: The interviewees in all NHs appraised WELCOME-IdA as generating positive change, although it proved important that some adjustments were made to the intervention and the organization. Thirteen CFIR constructs out of the domains intervention characteristics, inner setting, and process proved to be essential for understanding the different course that the implementation of WELCOME-IdA took in each of the four NHs. This is reflected in three types of WELCOME-IdA implementation: (1) priority on adjusting the intervention to fit the organization, (2) priority on adjusting the organization to fit the intervention, and (3) no setting of priorities in adjusting either the organization or the intervention. CONCLUSION: The unsatisfying results of the FallDem effectiveness trial can in part be explained with regard to the interplay between the intervention and the implementation which was revealed in the processes that occurred in the organizations during the implementation of the WELCOME-IdA intervention. Future implementation of WELCOME-IdA should be tailored based on an analysis of the organization's readiness, resources, and capacities and should also define custom-made intervention and implementation outcomes to measure success. Furthermore, our results confirm that the CFIR can be used beneficially to conduct process evaluations.

Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol.

BACKGROUND: Complex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations. METHODS: The design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by "hand searching" techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team. DISCUSSION: The findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study. SYSTEMATIC REVIEW REGISTRATION: This study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732 .

Dealing with the behaviour of residents with dementia that challenges: A stepped-wedge cluster randomized trial of two types of dementia-specific case conferences in nursing homes (FallDem).

BACKGROUND: The negative effects of behavioural changes among dementia residents and the consequences for caregivers are a major problem in the care of people with dementia. Case conferences (CC) are recommended as a useful method to understand the underlying causes of the behaviour and to plan tailored interventions OBJECTIVES: The aim of this article is to describe the effects of two dementia-specific CC models on the prevalence of behaviour that challenges and other secondary outcomes. DESIGN: Stepped-wedge cluster randomized trial. SETTING: Nursing homes: The inclusion criterion was the participation of at least two units with a minimum of 30 residents who were mainly cared for in the study units. PARTICIPANTS: A total of 224 residents and 189 staff from six nursing homes in the IdA (Innovative dementia-orientated Assessment system) cohort and 241 residents and 284 staff from six nursing homes in the Neo (Narrative Approach) cohort were included in the study. The inclusion criteria were the following: medical diagnosis of dementia from nursing charts, FAST (Functional Assessment Staging) score > 1, living at least 15 days in the unit, and informed consent. METHODS: The nursing homes were randomized to the type of intervention and time point of intervention delivery. The two interventions in the form of the case conference models (Welcome-IdA and -Neo) differed in the type of behaviour analysis method. The intervention duration was seven months. The primary outcome was the change in the prevalence of behaviour that challenges. Secondary outcomes were residents' quality of life, prescription of psychotropic medications, formal caregiver burnout, dementia-related stress, and vocational action competence. The outcomes were measured on seven data points every three months. Linear mixed-effects models were used to analyze intervention effects between the control, intervention and follow-up periods. RESULTS: No differences were found concerning the primary outcome between the control and intervention cohorts for both CC models. Further exploratory data analyses showed a reduction in behaviours such as apathy (18%) and eating disturbances (29%) for the IdA cohort and hallucination (27%) and delusion (28%) in the NEO cohort. Only staff in the IdA cohort demonstrated a reduction in work-related burnout from the control phase to the intervention phase. CONCLUSION: Specific CC for behaviour that challenges do not decrease the overall prevalence of residents showing changes in behaviour. However, there are indications that the case conferences influence some types of behaviour and reduce the risk factors for work-related burnout.

Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study.

BACKGROUND: A system of dementia-specific case conferences (WELCOME-IdA) was evaluated using a stepped-wedge design in six nursing homes (NHs) to enable nursing staff to analyse properly the behavioural and psychological symptoms (BPSD) of residents with dementia. A process evaluation of the context, the recruitment and target populations reached (residents and nursing staff) and the delivery of the intervention and implementation strategy was carried out to explore the lack of effectiveness of WELCOME-IdA on the residents' prevalence of BPSD. METHODS: This study was part of a larger process evaluation using a mixed-methods design. Standardised questionnaires, semi-structured interviews, attendance lists, standardised protocols and written self-reports were used to collect the data. The quantitative data were analysed by calculating descriptive statistics. The qualitative interviews were analysed using deductive content analysis and the self-reports were analysed using a documentary analysis. RESULTS: None of the NHs had prior experience with dementia-specific case conferences on a specific concept related to BPSD. The number of residents for whom a dementia-specific case conference was held was lower than expected. The number of nursing staff reached was high, although as defined in the study protocol, core nursing teams continuously participating in all components of the intervention were not established throughout the study. An analysis of the delivery of the intervention showed a reduction in the frequency of dementia-specific case conferences and deviations in the process structure and role structure of WELCOME-IdA. The strategy used to facilitate the implementation of WELCOME-IdA was mostly followed. An analysis of the recruitment of residents indicated that the variation in which residents were included in the study sample was high and that the intended sample size required to achieve a power >80% was not reached. CONCLUSION: An analysis of the process evaluation data indicated that there were inaccuracies in the implementation of WELCOME-IdA and there were methodological limitations within the design of the effectiveness trial, both of which could explain the lack of effectiveness of WELCOME-IdA. To optimise the process structure of WELCOME-IdA, an assessment of BPSD and a pre-selection of possible domains for the behavioural analysis could be conducted prior to a dementia-specific case conference. TRIAL REGISTRATION: ISRCTN20203855 . Registered on 10 July 2013.

A Tablet App- and Sensor-Based Assistive Technology Intervention for Informal Caregivers to Manage the Challenging Behavior of People With Dementia (the insideDEM Study): Protocol for a Feasibility Study.

BACKGROUND: Despite the enormous number of assistive technologies (ATs) in dementia care, the management of challenging behavior (CB) of persons with dementia (PwD) by informal caregivers in home care is widely disregarded. The first-line strategy to manage CB is to support the understanding of the underlying causes of CB to formulate individualized nonpharmacological interventions. App- and sensor-based approaches combining multimodal sensors (actimetry and other modalities) and caregiver information are innovative ways to support the understanding of CB for family caregivers. OBJECTIVE: The main aim of this study is to describe the design of a feasibility study consisting of an outcome and a process evaluation of a newly developed app- and sensor-based intervention to manage CB of PwD for family caregivers at home. METHODS: In this feasibility study, we perform an outcome and a process evaluation with a pre-post descriptive design over an 8-week intervention period. The Medical Research Council framework guides the design of this feasibility study. The data on 20 dyads (primary caregiver and PwD) are gathered through standardized questionnaires, protocols, and log files as well as semistructured qualitative interviews. The outcome measures (neuropsychiatric inventory and Cohen-Mansfield agitation inventory) are analyzed by using descriptive statistics and statistical tests relevant to the individual assessments (eg, chi-square test and Wilcoxon signed-rank test). For the analysis of the process data, the Unified Theory of Acceptance and Use of Technology is used. Log files are analyzed by using descriptive statistics, protocols are analyzed by using documentary analysis, and semistructured interviews are analyzed deductively using content analysis. RESULTS: The newly developed app- and sensor-based AT has been developed and was evaluated until July in 2018. The recruitment of dyads started in September 2017 and was concluded in March 2018. The data collection was completed at the end of July 2018. CONCLUSIONS: This study presents the protocol of the first feasibility study to encompass an outcome and process evaluation to assess a complex app- and sensor-based AT combining multimodal actimetry sensors for informal caregivers to manage CB. The feasibility study will provide in-depth information about the study procedure and on how to optimize the design of the intervention and its delivery. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11630.

Translation and Linguistic Validation of the German Challenging Behavior Scale for Formal Caregivers of People With Dementia in Nursing Homes.

BACKGROUND AND PURPOSE: The Challenging Behavior Scale (CBS) measures the behavior of individuals with dementia. The study aims to translate the English CBS into German (CBS-G) and test its linguistic validity. METHODS: The two-panel approach was used to translate the CBS. Nursing home staff reviewed the unambiguity and familiarity of the CBS-G items and the adequateness of the examples used to describe the items. Content validity indexes (CVI) and modified kappa (k) coefficients were calculated. RESULTS: Most of the CBS-G items had excellent CVI and k values for both unambiguity and familiarity. All examples were viewed as adequate. CONCLUSION: A German version of the CBS that is linguistically equivalent to the original CBS is available but needs further testing of its psychometric properties.

What is known about the subjective needs of people with behavioural variant frontotemporal dementia? A scoping review.

Behavioural variant frontotemporal dementia (bvFTD) is an early-onset and progressive neurodegenerative disease associated with strong changes in judgement, behaviour, personality and emotions. These changes can cause significant problems in everyday life for people with bvFTD and their families, and have implications for health and society. Currently, there are no suitable evidence-based specific interventions for people with bvFTD. This scoping review aims to identify the self-expressed needs, demands and coping strategies of people with bvFTD. Identifying these issues is the first step towards the development of need-based psycho-social interventions for people with bvFTD. A comprehensive literature research was conducted of German and English scientific articles published between January 2000 and October 2014 using the databases MEDLINE, CINAHL, PsycINFO, PSYNDEX, SocINDEX, GeroLit, the Cochrane Library, ProQuest, the German National Library and additional search strategies in terms of a scoping review. Articles were identified by combining search terms related to 'frontotemporal dementia' with terms related to 'self-expressions', 'needs/demands' and 'coping'. After excluding duplicates, two independent reviewers screened the titles and abstracts of 2317 records for eligibility. Because eligibility could not be assessed from the titles or abstracts of 28 articles, those articles were assessed using the full text. One poster abstract met our research question and a few articles were related, but no article met all of the inclusion criteria. This lack of scientifically based knowledge concerning the perspective of people with bvFTD is discussed with reference to the search strategy and the research questions, disease-related aspects such as changes in behaviour or language and emotions and the difficulties in researching this topic. Recommendations are formulated for future research considering the perspective of people with bvFTD and that will involve the development of appropriate data collection methods. Subsequently, specialised interventions must be developed.