Sleep-related measurements to assess sleep disturbances among people living with dementia in nursing homes: a systematic review.

BACKGROUND: There is a high prevalence of sleep disturbances among people living with dementia (PLWD) in nursing homes. Reliable and valid measurements are needed to assess these disturbances. The aim of this systematic review was to identify, analyze and synthesize studies of sleep-related measurements to assess sleep disturbances in PLWD. METHODS: The databases PubMed, CINAHL, and PsycINFO were systematically searched in 2019; the search was updated in March 2024. The inclusion criteria were as follows: participants with dementia or probable dementia in any care setting; and studies that reported at least one of the following aspects: (I) theoretical and conceptual frameworks, (II) user or patient involvement by type of users in measurement development, (III) feasibility and practicability of measurements, and (IV) results of psychometric analyses. The quality of the included studies was evaluated using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria and the quality appraisal tool for studies of diagnostic reliability (QAREL) tool. RESULTS: A total of 5169 studies were identified; ultimately, 15 studies describing three self-administered measurements, three proxy-administered measurements and two technological measurements were included. No sleep-related measurement showed acceptable psychometric properties in any of the COSMIN domains. CONCLUSIONS: No measurement without adaptation can be recommended for PLWD in nursing homes. If existing measurements are used in clinical practice, the self-perspective of PLWD should be taken into account. If this is no longer fully possible, proxy-rating perspectives in combination could be an option. Future research on sleep-related measurements should be strictly based on international consensus-based psychometric quality criteria.

Addressing loneliness and social isolation through the involvement of primary and secondary informal caregivers in nursing homes: a scoping review.

OBJECTIVES: To clarify the mechanisms of interventions addressing loneliness and social isolation in older adults living in nursing homes through the involvement of primary and secondary informal caregivers. METHODS: This scoping review was performed by two independent reviewers, covering the period between 2011 and 2022 and the databases MEDLINE, CINAHL, PsycINFO and Scopus. It included terms related to (A) informal caregivers, (B) nursing homes, (C) psychosocial interventions, (D) involvement and (E) social isolation or loneliness. RESULTS: Thirty-three studies met the inclusion criteria. Although there were various definitions and assessment tools related to social isolation and loneliness, the studies referred to three dimensions of these concepts in nursing home residents: the quantity of social interactions, the perception of these encounters and biographical changes in social relationships. Most studies did not explicate the mechanisms of these interventions. The review uncovered the following aspects of intervention mechanisms: increasing opportunities for social contact, creating meaningful encounters, maintaining existing relationships with primary informal caregivers and establishing new ones with secondary informal caregivers. CONCLUSION: Studies reporting on interventions addressing loneliness and social isolation in nursing home residents need to clarify and detail their intervention mechanisms in order to foster more targeted interventions. In addition, there is a need for further research on large-scale programs or care philosophies in this field and the development of intervention designs, which allow for tailored intervention formats in order to respond to the individual perception of social relationships.

Association of personal and systemic factors on intrapartum risk perception and obstetric intervention rates: a cross-sectional study.

BACKGROUND: Risk perception is fundamental to decision-making; therefore its exploration is essential to gaining a comprehensive understanding of the decision-making process for peripartum interventions. The aim of this study was to investigate associations between personal and systemic factors of the work setting and the risk perception of obstetric healthcare professionals, and in turn how this might influence decisions regarding obstetric interventions. METHODS: Case vignettes were used to measure risk perception. A quantitative cross-sectional online survey was performed within an exploratory sequential mixed-methods design, and an intervention readiness score created. Associations were calculated using location and dispersion measures, t-tests and correlations in addition to multiple linear regression. RESULTS: Risk perception, as measured by the risk assessment score, was significantly lower (average 0.8 points) for midwives than for obstetricians (95%-CI [-0.673; -0.317], p < .001). Statistically significant correlations were found for: years of experience and annual number of births in the current workplace, but this was not clinically relevant; hours worked, with the groups of participants working ≥ 30,5 h showing a statistically significant higher risk perception than participants working 20,5-30 h (p = .005); and level of care of the current workplace, with the groups of participants working in a birth clinic (Level IV) showing a statistically significant lower risk perception than participants working in Level I hospital (highly specialised obstetric and neonatal care; p = .016). The option of midwife-led birthing care showed no correlation with risk perception. The survey identified that risk perception, occupation, years in the profession and number of hours worked (i.e. full or part time) represent significant influences on obstetric healthcare professionals' willingness to intervene. CONCLUSIONS: The results of the survey give rise to the hypothesis that the personal and systemic factors of professional qualification, occupation, number of hours worked and level of acuity of the workplace are related to the risk perception of obstetric healthcare professionals. In turn, risk perception itself made a significant contribution to explaining differences in willingness to intervene, suggesting that it influences obstetricians' and midwives' decision-making. Overall, however, the correlations were weak and should be interpreted cautiously. The significant variations in the use of interventions must be addressed in order to provide the highest quality and best possible care for childbearing women and their families. To this end, developing strategies to improve interdisciplinary relationships and collaboration is of great importance. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017172 (18.06.2019).

Intervention for sleep problems in nursing home residents with dementia: a cluster-randomized study.

OBJECTIVE: To reduce sleep problems in people living with dementia using a multi-component intervention. DESIGN: Cluster-randomized controlled study with two parallel groups and a follow-up of 16 weeks. SETTING: Using external concealed randomization, 24 nursing homes (NH) were allocated either to the intervention group (IG, 12 clusters, 126 participants) or the control group (12 clusters, 116 participants). PARTICIPANTS: Participants were eligible if they had dementia or severe cognitive impairment, at least two sleep problems, and residence of at least two weeks in a NH. INTERVENTION: The 16-week intervention consists of six components: (1) assessment of sleep-promoting activities and environmental factors in NHs, (2) implementation of two "sleep nurses," (3) basic education, (4) advanced education for staff, (5) workshops to develop sleep-promoting concepts, and (6) written information and education materials. The control group (CG) received standard care. MEASUREMENTS: Primary outcome was ≥ two sleep problems after 16 weeks assessed with the Sleep Disorders Inventory (SDI). RESULTS: Twenty-two clusters (IG = 10, CG = 12) with 191 participants completed the study. At baseline, 90% of people living with dementia in the IG and 93% in the CG had at least two sleep problems. After 16 weeks, rates were 59.3% (IG) vs 83.8% (CG), respectively, a difference of -24.5% (95% CI, -46.3% - -2.7%; cluster-adjusted odds ratio 0.281; 95% CI 0.087-0.909). Secondary outcomes showed a significant difference only for SDI scores after eight and 16 weeks. CONCLUSIONS: The MoNoPol-Sleep intervention reduced sleep problems of people living with dementia in NH compared to standard care.

Item distribution, internal consistency and structural validity of the German language person-centred climate questionnaire - staff version (PCQ-G-S): a cross-sectional study.

BACKGROUND: Person-centredness is considered as best practice for people living with dementia. A frequently used instrument to assess person-centredness of a care environment is the Person-centred Climate Questionnaire (PCQ). The questionnaire comprises of 14 items with the three subscales a climate of safety, a climate of everydayness and a climate of community. AIM: The aim of the study is to describe the translation process of the English language Person-centred Climate Questionnaire (Staff version, Patient version, Family version) into German language (PCQ-G) and to evaluate the first psychometric properties of the German language Person-centred Climate Questionnaire- Staff version (PCQ-G-S). METHODS: We conducted a cross-sectional study. The three versions of the 14-item English PCQ were translated into German language (PCQ-G) based on the recommendations for cross-cultural adaption of measures. Item distribution, internal consistency and structural validity of the questionnaire were assessed among nursing home staff (PCQ-G-S). Item distribution was calculated using descriptive statistics. Structural validity was tested using principal component analysis (PCA), and internal consistency was assessed for the resulting subscales using Cronbach's alpha. Data collection took place from May to September 2021. RESULTS: A total sample of 120 nurses was included in the data analysis. Nine out of 14 items of the PCQ-G-S demonstrated acceptable item difficulty, while five times showed a ceiling effect. The PCA analysis demonstrated a strong structural validity for a three-factor solution explaining 68.6% of the total variance. The three subscales demonstrated a good internal consistency with Cronbach's alpha scores of 0.8 for each of the subscales. CONCLUSION: The analysis of the 14-item German version (PCQ-G-S) showed first evidence for a strong internal consistency and structural validity for evaluating staff perceptions of the person-centredness in German nursing homes. Based on this, further investigations for scale validity of the PCQ-G versions should be carried out.

[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.

Perspectives on sleep of people living with dementia in nursing homes: a qualitative interview study.

BACKGROUND: Disturbed sleep among people living with dementia in nursing homes is widespread and is associated with diseases and all-cause mortality. This study examined the sleep of people living with dementia from their perspectives in nursing homes and that of the nurses who care for people living with dementia. METHODS: A qualitative cross-sectional study was conducted. A total of 15 people living with dementia and 15 nurses in 11 German nursing homes were enrolled in this study. Data was collected between February and August 2021 through semistructured interviews, which were audio recorded and transcribed. Thematic analyses were performed by three independent researchers. Thematic mind maps and controversial findings were discussed with the Research Working Group of People with Dementia of the German Alzheimer Association. RESULTS: Thematic analysis identified five overarching themes from the nursing home participants regarding sleep patterns: (1) characteristics of good sleep, (2) characteristics of bad sleep, (3) personal influences of people living with dementia on sleep, (4) environmental factors on sleep, and (5) sleep strategies of people living with dementia. Analysis also identified five overarching themes from the nurses participants: (1) characteristics of good sleep, (2) characteristics of bad sleep, (3) personal influences on sleep, (4) environmental factors on sleep, and (5) interventions for sleep promotion. CONCLUSIONS: The thematic analyses demonstrated that the perspectives of people living with dementia and nurses indicate the need to give more consideration to psychosocial factors and individual aspects of sleep in clinical practice. The results could also be helpful for the development of targeted assessment instruments and complex non-pharmacological interventions to promote sleep.

Interprofessional Needs Analysis and User-Centred Prototype Evaluation as a Foundation for Building Individualized Digital Education in Dementia Healthcare Supported by Artificial Intelligence: A Study Protocol.

Continuous profession-specific training is necessary to provide high-quality care for people with dementia. Research shows the need for more educational programmes that are personalized and responsive to the learning needs and preferences of staff. Digital solutions supported by artificial intelligence (AI) may be a means of making these improvements. There is a lack of formats that support learners in selecting the right content according to their learning needs and preferences. The project "My INdividual Digital EDucation.RUHR" (MINDED.RUHR) addresses this problem and seeks to develop an automatized delivery system for individual learning content using AI. The sub-project presented here aims to achieve the following: (a) explore learning needs and preferences regarding behavioural changes in people with dementia, (b) develop learning nuggets, (c) evaluate the feasibility of the digital learning platform, and (d) identify optimization criteria. Following the first phase of the framework for the design and evaluation of digital health interventions (DEDHI), we use a qualitative approach with focus group interviews for exploration and development, and co-design workshops and expert audits to evaluate the developed learning nuggets. The developed e-learning tool is the first step in supporting the digital training of healthcare professionals in the context of caring for people with dementia, individualized through AI.

Attitudes and knowledge of nurses working at night and sleep promotion in nursing home residents: multicenter cross-sectional survey.

BACKGROUND: Sleep disturbances are common in nursing home residents and challenging for their nurses. Knowledge about sleep and sleep promoting factors is essential to provide adequate sleep management, where nurses play a key role. Therefore, nurses' knowledge and attitudes towards sleep and sleep promoting interventions is important as enabling or inhibiting factor for successful sleep management. METHODS: A multicenter cross-sectional study was conducted among nurses working wholly or partially at night in nursing homes in Germany. Data were collected between February and April 2021 via online or paper and pencil questionnaires, comprising 56 items. Nursing homes were recruited through existing cooperation with the study centers as well as via nursing home registers. RESULTS: Finally, 138 nursing homes participated and 271 nurses completed the survey. Nurses agreed that sleep disturbances are an important topic with important impact on resident' health. Although, the assessment of sleep was seen as nurses' responsibility, only 40 nurses (14.7%) stated that residents' sleep was always documented. Only 21.7% reported the availability of policy documents providing guidance regarding the management of sleep disturbances. The vast majority (93.2%) reported never having received training about sleep and management of sleep disturbances after their basic nursing training. CONCLUSIONS: Our results indicate that nurses working at night can play an important role in residents' sleep promotion. The findings indicate nurses' educational needs regarding sleep and sleep promotion. Nursing homes should implement institutional guidelines in order to promote residents' sleep based on adequate evidence-based non-pharmacological interventions.

Person-centered assessment of apathy and resistance to care in people living with dementia: Review of existing measures.

Introduction: The review described in this paper builds upon the Dementia Care Practice Recommendations (DCPR) published by the Alzheimer's Association in 2018 and addresses behavior change and the need for targeted outcome measures that evolve from person-centered frameworks and help evaluate interventions. Apathy and resistance to care (RTC) are two specific behavioral expressions of unmet need or distress exhibited by people living with dementia, which are upsetting to formal and family caregivers and compromise quality of life for people living with dementia. Methods: We conducted literature searches of major databases (PsycInfo, PubMed, EBSCO, CINAHL) for papers examining apathy and RTC constructs in samples of people living with dementia. Reliability and validity coefficients were reviewed and reported, along with examination of whether each measure facilitates contextual understanding of behavior. Results: Three stand-alone measures of RTC and ten measures of apathy were identified and reviewed. The RTC measures demonstrated good psychometric properties but do not include the perspective of the person living with dementia or contextual aspects of the behavior. The identified apathy measures demonstrated fair to good psychometric properties, and although there is greater consideration of context, none adequately include the perspective of the person living with dementia. Discussion: Although reliable and valid measures have been developed to measure apathy and RTC in people living with dementia, there is greater need for conceptually driven measurement of behavior context and for tools that elicit and include the perspective of the person living with dementia.

Intrapartum risk perception-A qualitative exploration of factors affecting the risk perception of midwives and obstetricians in the clinical setting.

OBJECTIVE: to gain an in-depth view of the specific risk perception of midwives and obstetricians, in order to achieve a deeper understanding of the situations which midwives and obstetricians perceive as risky and of the factors affecting their risk perception. DESIGN: a qualitative approach using focus group discussions was used as part of the first strand within a sequential explorative mixed methods project. PARTICIPANTS: 24 midwives and obstetricians providing labour care in the clinical setting ANALYSIS: according to qualitative content analysis. FINDINGS: both external and internal factors were identified which potentially influence the risk perception of midwives and obstetricians: (i) the individual perception of the obstetric health professional, (ii) the dyad of obstetric health professional & woman, (iii) being part of a team and (iv) being part of an institution. While risk definitions/classifications and obstetric risk factors were less common topics, structural and organisational factors, such as lack of staff and excessive workload, dominated the discussions about risky situations in the delivery room. KEY CONCLUSION: Obstetric health professionals' risk perception is multifactorial and risky situations in the delivery room can be described as a complex construct of various factors. The results suggest that there are different forms of risk perception and different factors which are perceived as risky. IMPLICATIONS FOR PRACTICE: Reflection on one's own role and actions should be included in the training of obstetric professionals and also be maintained in everyday professional life.

Determinants of Self-Stigma in People with Parkinson's Disease: A Mixed Methods Scoping Review.

BACKGROUND: Self-stigma in people with Parkinson's disease (PD) can substantially impact quality of life and possibilities for social participation. An integrative analysis of determinants of self-stigma has been lacking. OBJECTIVE: We sought to explore which complementary insights from qualitative and quantitative studies, as well as from expert consultation, could be gained. METHODS: An established mixed methods study design was employed to first conduct a mixed methods scoping review of published qualitative and quantitative literature, and then consult with experts to arrive at an exhaustive list of determinants of self-stigma after a thematic synthesis. RESULTS: A total of 87 unique determinants of self-stigma were identified. Quantitative studies and expert consultations mainly identified personal determinants of people with self-stigma (e.g., age, anxiety, or apathy). In contrast, qualitative studies identified social situations associated with self-stigma (e.g., joint meals of people with typical PD with others). Notably, self-stigma of people with PD was found to be particularly salient in unfamiliar places, at the working place or in contact with people without PD. Across methods, cognitive impairment, tremor, and abnormal walk and unsteady gait, respectively, were associated with self-stigma. CONCLUSION: The mixed method study design yielded complementary insights, but also factors commonly associated with self-stigma across methods. Future prioritization exercises may gain further insights into self-stigma of people with PD. Facilitating social encounters by both addressing needs of affected people and raising knowledge and public awareness may improve quality of life in people with PD.

[A care concept and its contribution to the stability of home-based care arrangements : Cross-sectoral care between vision and reality]. / Beitrag eines Versorgungskonzeptes zur Stabilität häuslicher Versorgungsarrangements : Sektorenverbindende Versorgung zwischen Vision und Wirklichkeit.

BACKGROUND: As most older people in Germany wish to remain in their homes even in the case of increasing need for support, new forms of care are emerging in many locations. The aim of these new forms of care is to promote the stability of home-based care arrangements, which is also the aim of the so-called overall care concept of the municipal nursing home provider in Krefeld. The idea is that users of this concept are able to obtain a cross-sectoral broad spectrum of services which are tailored to their care needs. OBJECTIVE: This article presents to what extent users (people in need of help and/or care and their family carers) experience the contribution of the overall care concept over time as stabilizing with respect to the home-based care arrangement. MATERIAL AND METHODS: For this purpose, 24 interviews with 10 people in need of care and/or their family carers were analyzed by means of qualitative content and by cross-case longitudinal analyses. RESULTS: Some users experienced the contribution of the overall care concept as stabilizing, some experienced it ambivalently and occasionally users experienced a negative development trend. CONCLUSION: Concepts can have a stabilizing effect if they continuously correspond to the individual ideas and needs of the person in need of care and family carer(s). In order to do so, communicative negotiation processes between the provider and the care dyads could be a promising approach.

Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial.

BACKGROUND: Sleep problems are highly prevalent in people with dementia. Nevertheless, there is no "gold standard" intervention to prevent or reduce sleep problems in people with dementia. Existing interventions are characterized by a pronounced heterogeneity as well as insufficient knowledge about the possibilities and challenges of implementation. The aim of this study is to pilot and evaluate the effectiveness of a newly developed complex intervention to prevent and reduce sleep problems in people with dementia living in nursing homes. METHODS: This study is a parallel group cluster-randomized controlled trial. The intervention consists of six components: (1) the assessment of established sleep-promoting interventions and an appropriate environment in the participating nursing homes, (2) the implementation of two "sleep nurses" as change agents per nursing home, (3) a basic education course for nursing staff: "Sleep problems in dementia", (4) an advanced education course for nursing staff: "Tailored problem-solving" (two workshops), (5) workshops: "Development of an institutional sleep-promoting concept" (two workshops with nursing management and sleep nurses) and (6) written information and education material (e.g. brochure and "One Minute Wonder" poster). The intervention will be performed over a period of 16 weeks and compared with usual care in the control group. Overall, 24 nursing homes in North, East and West Germany will be included and randomized in a 1:1 ratio. The primary outcome is the prevalence of sleep problems in people with dementia living in nursing homes. Secondary outcomes are quality of life, quality of sleep, daytime sleepiness and agitated behavior of people with dementia, as well as safety parameters like psychotropic medication, falls and physical restraints. The outcomes will be assessed using a mix of instruments based on self- and proxy-rating. A cost analysis and a process evaluation will be performed in conjunction with the study. CONCLUSIONS: It is expected that the intervention will reduce the prevalence of sleep problems in people with dementia, thus not only improving the quality of life for people with dementia, but also relieving the burden on nursing staff caused by sleep problems. TRIAL REGISTRATION: Current controlled trials: ISRCTN36015309 . Date of registration: 06/11/2020.

Characteristics of multicomponent, nonpharmacological interventions to reduce or avoid sleep disturbances in nursing home residents: a systematic review.

BACKGROUND: Dementia guidelines propose the use of nonpharmacological interventions for sleep disturbances for older people. Based on available reviews, it seems most likely that multicomponent interventions have the strongest potential to be effective in improving sleep. However, a detailed description of multicomponent interventions is missing. This systematic review aims to identify, describe, and summarize multicomponent, nonpharmacological interventions to reduce or avoid sleep disturbances in nursing home residents. METHODS: This review followed established methodological frameworks for systematic evidence syntheses. A computerized search was conducted in December 2018, using the databases PubMed, CINAHL, Scopus, and Cochrane Library. Two independent reviewers assessed all search results to identify eligible studies and assessed studies' methodological quality following the Cochrane Risk of Bias methodology for randomized controlled trials and the CASP Appraisal Checklist for controlled trials.Evaluation studies of any design investigating multicomponent interventions were included, except case studies. Components of included intervention programs were analyzed applying the TIDieR and CReDECI 2 criteria. RESULTS: A total of 2056 studies were identified through the database search; ten publications about nine interventions met the inclusion criteria and were included in the review. The identified interventions can be summarized assigned to the categories "daytime activities," "nighttime activities," "staff training," and "light exposure." The approaches showed similarities and differences in procedures, materials, modes of delivery, intervention provider, and intervention period. None of the studies described any intended interactions between components or considered context characteristics in intervention modeling as well as internal and external facilitators or barriers influencing delivery of intervention. We identified positive or mixed positive effects for sleep-related outcomes for the mentioned categories. CONCLUSIONS: The analysis of included interventions demonstrates somehow promising results, although findings are difficult to interpret as interventions were not well described, and the challenges of developing and evaluating complex interventions were not sufficiently acknowledged.

Burden of caregivers of patients with frontotemporal lobar degeneration - a scoping review.

BACKGROUND: Frontotemporal lobar degeneration (FTLD) is the second-most common cause of young-onset dementia. Personality and behavior changes lead to high caregiver stress and burden, but little support is available. Our aim is to present the evidence on the characteristics, challenges and unmet needs of caregivers as well as on possible interventions. METHODS: We conducted a scoping review on caregiver burden using PubMed, Web of Science and ScienceDirect. A total of 69 articles were considered eligible and were analyzed in the present study. RESULTS: Through the analysis of 69 empirical articles, our results show that caregivers of patients with FTLD are often younger in age, have children and find behavioral disturbances to be the most burdensome. Nine studies assessed the needs of and support for caregivers. Ten studies compared the burden in different forms of FTLD, 19 compared FTLD to other types of dementia, and one compared the caregiver burden between two countries. Eight studies reported on interventions for caregivers or interventions taking burden into account. One study assessed the support structure for caregivers of FTLD patients. Five case reports, eight research overviews and three reviews addressed specific needs and challenges. CONCLUSIONS: Further research should reproduce and validate efficacious interventions and focus on underage children of FTLD patients and findings from non-Western countries. Additionally, support structures for FTLD caregivers should be assessed and extended. Awareness both in the wider population and among healthcare professionals is an urgent need for the future.

Risk Perception of Health Professionals in Intrapartum Care Decisions: Protocol for a Mixed Methods Study.

BACKGROUND: Risk perception plays an important role in decision-making processes. Differences in obstetric intervention rates suggest that, in addition to medical indications, the risk perception of obstetric health professionals might have a major influence on their decision-making process during childbirth. Although studies have investigated whether risk perception affects the role of midwifery or influences decision making during childbirth, little is known about what obstetric health professionals actually perceive as risk or risky situations and whether different risk perceptions lead to more interventions during intrapartum care. OBJECTIVE: The objective of this study is to understand the association of risk perception and the decision-making processes of obstetric health professionals (midwives and obstetricians) in Germany during intrapartum care. The study has 3 specific aims: (1) gain insight into what obstetric health professionals perceive as risk in the German clinical setting, (2) assess the extent to which personal and systemic factors have an impact on obstetric health professionals' risk perception, and (3) investigate whether different perceptions of risk are associated with different decisions being made by obstetric health professionals. METHODS: This is an exploratory sequential mixed methods study with 2 phases, a qualitative followed by a quantitative phase. In the first phase, qualitative data are collected and analyzed by conducting focus group discussions and applying qualitative content analysis to address aim 1. In the second phase, for aims 2 and 3 and to help explain the qualitative results, quantitative data are collected and analyzed by conducting an observational study using case vignettes within a survey constructed on the basis of the qualitative results. RESULTS: Enrollment in the first (qualitative) phase began in July 2019, and data collection and analysis have been completed. The second (quantitative) phase is currently planned, and data collection is expected to start in December 2020. First results of the qualitative phase are expected to be submitted for publication in 2020, with completion of the second phase scheduled for 2021. CONCLUSIONS: This mixed methods study will examine the perception of risk and its association with the decision-making processes of obstetric health professionals during their care of women in childbirth. The rationale for this approach is that the qualitative data and their analysis explore participants' views in more depth, while the quantitative data will help to provide and explore a general understanding of the research problem. The results are expected to be relevant to health care professionals, policymakers, and educational institutions in order to minimize underuse, overuse, and misuse of interventions during intrapartum care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017172; https://tinyurl.com/y2zoowkx. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21443.

TALKING TIME: A pilot randomized controlled trial investigating social support for informal caregivers via the telephone.

BACKGROUND: Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home. METHODS: This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12). RESULTS: Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention. CONCLUSIONS: The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).