Bayesian design and analysis of two-arm cluster randomized trials using assurance.

We consider the design of a two-arm superiority cluster randomized controlled trial (RCT) with a continuous outcome. We detail Bayesian inference for the analysis of the trial using a linear mixed-effects model. The treatment is compared to control using the posterior distribution for the treatment effect. We develop the form of the assurance to choose the sample size based on this analysis, and its evaluation using a two loop Monte Carlo sampling scheme. We assess the proposed approach, considering the effect of different forms of prior distribution, and the number of Monte Carlo samples needed in both loops for accurate determination of the assurance and sample size. Based on this assessment, we provide general advice on each of these choices. We apply the approach to the choice of sample size for a cluster RCT into poststroke incontinence, and compare the resulting sample size to that from assurance based on a Wald test for the treatment effect. The Bayesian approach to design and analysis developed in this article can offer advantages in terms of an increase in the robustness of the chosen sample size to parameter mis-specification and reduced sample sizes if prior information indicates the treatment effect is likely to be larger than the minimal clinically important difference.

Video-based e-learning program for schoolteachers to support children of parents with mental illness: a cluster randomized trial.

BACKGROUND: Some children of parents with mental illness need support. This study aimed to develop and test the effectiveness of an e-learning program for training elementary schoolteachers to support children of parents with mental illness. METHODS: The program, which included a 30-min video-based e-learning program, aimed to help schoolteachers gain basic knowledge about mental illness and children of parents with mental illness, recognize children in need of support, and gain confidence in supporting them. A school-based cluster randomized controlled trial was conducted, and the schools were randomly divided into intervention and control groups. The teachers at these schools signed up for the program and participated individually. The outcome measures for the schoolteachers were evaluated at three time points: baseline (T1), post (T2), and one month later (T3). Along with the Sense of Coping Difficulty subscale (primary outcome measure), the following self-developed outcome measures were used: actual behaviors and attitude toward supporting children, knowledge, and self-assessment of program goals achievement. The Sense of Coping Difficulty subscale results at T3 were compared between the groups. Effectiveness over time was assessed for all the outcome measures. The interaction between baseline and intervention effects on the Sense of Coping Difficulty subscale was analyzed. As a part of the process evaluation, open-ended text responses were analyzed qualitatively. RESULTS: Baseline responses were collected from 87 participants in the intervention group and 84 in the control group. The total score of the Sense of Coping Difficulty subscale at T3 was significantly lower in the intervention group than in the control group (p = 0.007). Over time, a significant effect was observed on the Sense of Coping Difficulty subscale, actual behavior, knowledge of onset timing and probability of onset, and achievement of all program goals. Exploratory analysis was particularly effective for those who encountered a high level of difficulty in supporting children. The participants' text responses indicated that they planned to look carefully at children's backgrounds and stay close to them in the future. CONCLUSIONS: The program was effective for schoolteachers in supporting children of parents with mental illness. TRIAL REGISTRATION: UMIN000045483; 14/09/2021.

A participatory ergonomics intervention to re-design work and improve the musculoskeletal health of paramedics: protocol for a cluster randomised controlled trial.

BACKGROUND: In this paper, we present the protocol for a cluster randomised controlled trial to evaluate the effectiveness and implementation of a participative risk management intervention to address work-related musculoskeletal disorders (WMSDs). The aims of the study include to evaluate the implementation process and the impact of the intervention on work related musculoskeletal pain and discomfort and exposure to physical and psychosocial hazards in paramedics over a 12-month period. METHODS: The intervention in this study is to implement A Participative Hazard Identification and Risk Management (APHIRM) toolkit in an ambulance service. Eighteen work groups containing eligible participants (registered paramedics) will be randomised into the intervention or wait-list control arm in one of three rolling recruitment periods. The APHIRM toolkit survey will be offered at baseline and 12 months later, to all current eligible participants in each work group allocated to the trial. The intervention work groups will receive the remainder of the APHIRM toolkit procedures. Identifying data about individual participants will not be collected in the survey, to protect participant privacy and encourage participation. Changes in primary (musculoskeletal pain and discomfort) and secondary (exposure to physical and psychosocial hazards at work) outcomes measured in the survey will be analysed comparing the baseline and follow up response of the cluster. A process evaluation is included to analyse the implementation and associated barriers or facilitators. DISCUSSION: This study is important in providing a comprehensive approach which focusses on both physical and psychosocial hazards using worker participation, to address WMSDs, a well-known and significant problem for ambulance services. The effectiveness of the intervention in work groups will be rigorously evaluated. If significant positive results are observed, the intervention may be adopted in ambulance services, both nationally and internationally. TRIAL REGISTRATION: ISRCTN77150219. Registered 21 November 2021.

Compliance with national snakebite treatment guidelines in rural Sri Lankan hospitals: a cluster randomized controlled trial of a brief educational intervention.

BACKGROUND: Snakebite is a global health problem that predominantly occurs in rural areas. In Sri Lanka, the majority of snakebite patients first present to smaller rural primary hospitals. Improving care delivered at rural hospitals has the potential to reduce morbidity and mortality from snakebites. OBJECTIVE: In this study, we evaluated whether an educational intervention would increase compliance with national snakebite treatment guidelines in primary hospitals. METHODS: The hospitals were randomized into educational intervention (n = 24) and control groups (n = 20). The intervention hospitals received a brief educational intervention based on Sri Lankan Medical Association (SLMA) guidelines on the management of snakebites. Control hospitals had free access to the guidelines but no additional promotion. Four outcomes were assessed: pre- and post-test knowledge at the completion of a one-day workshop of educational intervention (intervention group only); improvement in the quality of the patient's medical records; appropriateness of transfers to higher hospitals; and quality of overall management graded by a blinded expert. The data was collected over a period of 12 months. RESULTS: All case notes of snakebite hospital admissions were reviewed. There were 1021 cases in the intervention group hospitals and 1165 cases in the control hospitals. Four hospitals in the intervention group and three hospitals in the control group did not have snakebite admissions and were excluded from the cluster analysis. The absolute quality of care was high in both groups. Post-test knowledge was improved (p < 0.0001) following the intervention group's educational workshop. There was no statistical difference between the two groups in terms of clinical data documentation in hospital notes (scores, p = 0.58) or transfer appropriateness (p = 0.68)-both of which were significantly different from the guidelines. CONCLUSION: Education of primary hospital staff improved the immediate knowledge gained but did not improve record-keeping or the appropriateness of inter-hospital patient transfer. TRIAL REGISTRATION: The study was registered with Sri Lanka Medical Associations' clinical trial registry. Reg. No SLCTR -2013-023. Registered: 30/07/2013.

Statistical power and sample size requirements to detect an intervention by time interaction in four-level longitudinal cluster randomized trials.

Cluster/group randomized controlled trials (CRTs) have a long history in the study of health sciences. CRT is a special type of intervention trial in which a complete group is randomly assigned to a study condition (or intervention). It is typically performed when individual randomization is difficult/impossible without substantial risk of contamination across study arms or prohibitive from the cost or group dynamics point of view. In this article, the aim is to design and analyze four-level longitudinal cluster randomized trials. The main interest here is to study the difference between treatment groups over time for such a four-level hierarchical data structure. This work is motivated by a real-life study for education based HIV prevention. Such trials are not only popular for administrative convenience, ethical considerations, subject compliance, but also help to reduce contamination bias. A random intercept mixed effects linear regression including a time by intervention interaction is used for modeling. Closed form expression of the power function to detect the interaction effect is determined. Sample size equations depend on correlation among schools but not on correlations among classes or students while, the power function depends on the product of number of units at different levels. Optimal allocation of units under a fixed cost by minimizing the expected standardized variance is also determined and are shown to be independent of correlations among units in any level. Results of detailed simulation studies find the theoretical power estimates based on the derived formulae close to the empirical estimates.

Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working males. In response, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The common aims of MATES programs are to improve suicide prevention literacy, help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with waitlist controls across up to 12 manufacturing worksites in Australia. We hypothesise that after 8 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to waitlist controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction and a joint labour-management Steering Group.Trial registration: The trial was registered retrospectively with the Australian New Zealand Clinical Trials Registry on 25 January 2022 (ACTRN12622000122752).Protocol version: 2.0, November 2022.

The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial.

AIMS: To investigate the short-term effect of implementing a modified comprehensive geriatric assessment and regularly case conferencing in nursing homes on neuropsychiatric symptoms. BACKGROUND: Neuropsychiatric symptoms are common and may persist over time in nursing home residents. Evidence of effective interventions is scarce. DESIGN: A parallel cluster-randomised controlled trial. METHODS: The intervention was monthly standardised case conferencing in combination with a modified comprehensive geriatric assessment. The control group received care as usual. MAIN OUTCOME MEASURE: The total score on the short version of the Neuropsychiatric Inventory (NPI-Q, 12-items). RESULTS: A total of 309 residents at 34 long-term care wards in 17 nursing homes (unit of randomisation) were included. The intervention care units conducted on average two case conference-meetings (range 1-3), discussing a mean of 4.8 (range 1-8) residents. After 3 months, there were no difference of NPI-Q total score between the intervention (-0.4) and the control group (0.5) (estimated mean difference = -1.0, 95% CI -2.4 to 0.5, p = 0.19). There was a difference in favour of the intervention group on one of the secondary outcome measures, the apathy symptoms (-0.5 95% CI: -0.9 to -0.1, p = 0.03). CONCLUSION: In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms. The intervention group had less apathy at 3 months follow-up compared to those receiving care as usual. The findings suggest that a more comprehensive intervention is needed to improve the total Neuropsychiatric symptoms burden and complex symptoms. TRIAL REGISTRATION: Due to delays in the organisation, the study was registered after study start, i.e. retrospectively in Clinicaltrials.gov # NCT02790372 at  https://clinicaltrials.gov/ ; Date of clinical trial registration: 03/06/2016.

Masked analysis for small-scale cluster randomized controlled trials.

Researchers conducting small-scale cluster randomized controlled trials (RCTs) during the pilot testing of an intervention often look for evidence of promise to justify an efficacy trial. We developed a method to test for intervention effects that is adaptive (i.e., responsive to data exploration), requires few assumptions, and is statistically valid (i.e., controls the type I error rate), by adapting masked visual analysis techniques to cluster RCTs. We illustrate the creation of masked graphs and their analysis using data from a pilot study in which 15 high school programs were randomly assigned to either business as usual or an intervention developed to promote psychological and academic well-being in 9th grade students in accelerated coursework. We conclude that in small-scale cluster RCTs there can be benefits of testing for effects without a priori specification of a statistical model or test statistic.

An individualized telephone-based care support program for rural family caregivers of people with dementia: study protocol for a cluster randomized controlled trial.

BACKGROUND: There are about 9.5 million people with dementia in China. Up to 99% of them are cared for by their family caregivers. Family caregivers are confronted with considerable difficulties and challenges while providing care. They often experience high levels of emotional, physical, financial, and social burdens. Caregivers in rural areas experience an even higher level of burden compared to their counterparts in urban areas due to fewer health resources for dementia care. However, so far, no intervention study has been conducted to support family caregivers in rural areas of China. The aim of this proposed study is to adapt and evaluate an evidence-based and culturally-tailored individualized telephone-based care support (ITBCS) program for family caregivers of people with dementia in rural China. METHODS: A cluster randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of the ITBCS compared with usual care for Chinese rural family caregivers of people with dementia. A total sample of 168 rural family caregivers will be recruited. The intervention components consist of a 3-month intensive telephone-based care support intervention followed by telephone-based follow-up consultations for 6 months. The control group will receive usual care services available for them. Outcome measures include carers' subjective burden, depressive symptoms, health-related quality of life, social support, caregiving self-efficacy, and care recipients' difficult behaviours and competence in activities of daily living at 3, 9 and 15 months after baseline. The potential cost-effectiveness of the ITBCS compared with usual care will be assessed as well. DISCUSSION: If effective, the ITBCS program can be adapted and used in rural areas of China as a blueprint to improve the quality of home-based care for people with dementia. Findings from the present study are significant for developing evidence-based dementia care policy in rural China. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2000038821 , Registered 4 April 2020, http://www.chictr.org.cn/showprojen.aspx?proj=62268 .

Effects of a school-based physical activity intervention on academic performance in 14-year old adolescents: a cluster randomized controlled trial - the School in Motion study.

BACKGROUND: School-based physical activity interventions evaluating the effect on academic performance usually includes children. We aimed to investigate the effect of a nine-month, school-based physical activity intervention titled School in Motion (ScIM) on academic performance in adolescents. METHODS: Thirty secondary schools in Norway were cluster-randomized into three groups: the Physically active learning (PAL) group (n = 10), the Don't worry - Be Happy (DWBH) group (n = 10) or control (n = 10). Target dose in both intervention groups was 120 min/week of additional PA during school hours. Parental consent was obtained from 2084 adolescent students (76%). Standardized national tests in reading and numeracy was conducted at baseline and at the end of the intervention. We used linear mixed model to test intervention effects. We found significant intervention effects in numeracy and reading among students in both interventions when compared with controls. RESULTS: The mean difference in change in numeracy was 1.7 (95% CI: 0.9 to 2.5; Cohen's d = 0.12) and 2.0 (95% CI: 1.4 to 2.7; Cohen's d = 0.23) points in favour of students in the PAL and DWBH intervention, respectively. Similar results were found for reading, where the mean difference in change was 0.9 (95% CI 0.2 to 1.6; Cohen's d = 0.06) and 1.1 (95% CI 0.3 to 1.9; Cohen's d = 0.18) points in favour of students in the PAL and DWBH intervention, respectively. When conducting intention to treat analysis with imputed data the estimates were attenuated and some no longer significant. CONCLUSION: The ScIM study demonstrates that two different school-based PA interventions providing approximately 120 min of additional PA weekly over nine months, significantly improved numeracy and reading performance in 14-year old students compared with controls. However, the results should be interpreted with caution as the effect sizes reported were very small or small and the estimates were attenuated when conducting intention to treat analysis. Despite this, our results are still positive and suggest that PA interventions are viable models to increase academic performance among adolescents. TRIAL REGISTRATION: Retrospectively registered (25/01/2019): NCT03817047 .

Effect of a maternal counselling intervention delivered by community health workers on child nutrition: secondary analysis of a cluster randomised controlled trial in India.

BACKGROUND: India suffers from a double burden of malnutrition and anaemia. The Karnataka anaemia project indicated that a counselling intervention delivered by community health workers improved anaemia cure rates. OBJECTIVE: To evaluate the effect of maternal counselling on nutritional aspects of anaemia prevention. METHODS: Secondary analysis of a cluster randomised controlled trial (55 simultaneously randomised villages using random number generator in Chamrajnagar district, Northern India). In the intervention group mothers of anaemic children received five monthly counselling sessions plus usual care (iron and folic acid supplements), while mothers of anaemic children in the control group received usual care alone. Daily intake of nutrients related to anaemia prevention, i.e. iron (mg) and vitamin C (mg), was estimated using the 24-h dietary recall method at baseline and 6 months follow-up. Linear and logistic mixed regression models were used to assess between-groups difference in changes in nutrients intake from baseline to end of follow-up. Data collectors and analysts were blinded to the group assignment. RESULTS: Participants were 534 (intervention n = 303; usual treatment n = 231) anaemic children, aged 1 to 5 years and their caregivers, of whom 521(intervention n = 299 from 28 villages; usual treatment n = 222 from 27 villages) were retained at 6 months follow-up and included in the analysis. This study provides inconclusive evidence of improvement in the intake of nutrients that prevent anaemia from baseline to follow-up among the intervention compared to the control group; increase in iron intake was 0.24 mg/day (95% CI -0.67; 1.15) and increase in vitamin C intake was 4.61 mg/day (95% CI -0.69, 9.91). Although encouraging, it is notable that the overall intake of nutrients that prevent anaemia remained well below the national recommended daily allowance. CONCLUSION: This study provides inconclusive evidence of the effect of parental counselling on nutritional aspects of anaemia prevention. The results highlight the need to devise multi-component anaemia-prevention interventions that include facilitators of the availability of nutritious food and should be evaluated in studies that are adequately powered to detect nutritional changes. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number ISRCTN68413407 , prospectively registered on 17/12/2013.

Six- and Twelve-Month Follow-up Results of a Cluster Randomized Controlled Trial of a CBT-Based Group Course.

In the current study, we examined the durability of intervention gains over a 6- and 12-month follow-up period after the implementation of a CBT-based group intervention "Adolescent Coping with Depression Course" (ACDC) for adolescents with subclinical or mild-to-moderate depression. Data were collected from 228 youth, 133 of whom were allocated to the 14-week ACDC intervention and 95 to the usual care (UC) control condition. Analyses for the main outcome variable of depressive symptoms were performed using a random effects repeated measures piecewise growth model to estimate trajectory shape over time on an intention-to-treat basis. Results revealed that the reduction in depressive symptoms achieved during the intervention phase continued across the follow-up period for both ACDC and UC (i.e., depressive symptoms showed a significantly decreasing trend in both groups in intervention and follow-up phases); however, no differential effects between conditions were found during the follow-up phase. The direct and indirect effects of the intervention on the other outcome variables' follow-up results were also presented. ISRCTN registry ISRCTN19700389. Registered 6 October 2015. https://doi.org/10.1186/ISRCTN19700389 . Full Protocol: https://doi.org/10.1186/s12888-016-0954-y.

Effects of the Active Smarter Kids (ASK) physical activity intervention on cardiometabolic risk factors in children: A cluster-randomized controlled trial.

The onset of cardiometabolic diseases are recognized to occur in childhood. We aimed to investigate the effect of a school-based cluster-randomized controlled trial of physical activity (PA) on single and clustered cardiometabolic risk factors. We included 1129 fifth-grade children from 57 schools (≥seven children in each class) in Sogn and Fjordane County, Norway, randomized to 28 intervention schools and 29 control schools. The PA intervention was conducted between November 2014 and June 2015. Cardiometabolic risk factors were waist circumference (WC), systolic blood pressure (SBP), total cholesterol (TC):high-density lipoprotein (HDL)-ratio, triglycerides (TG), homeostatic model assessment (HOMA)-score, and cardiorespiratory fitness (CRF). PA was measured by accelerometry. No significant intervention effects were found for single or clustered cardiometabolic risk factors. However, in children with the less favorable baseline values, beneficial effects were found for SBP (p = 0.07 for group ∗ tertile interaction), TC:HDL ratio (p = 0.03 for group ∗ tertile interaction) and the clustered cardiometabolic risk score (p = 0.01 for group ∗ tertile interaction). Compared to boys, girls had a greater effect of the intervention on WC (p = 0.03 for group ∗ sex interaction) and CRF (p < 0.001 for group ∗ sex interaction). The majority of the children had high PA levels, thus limited potential for change, and we found no effects of the PA intervention on cardiometabolic risk in the total sample. However, the intervention had a significantly enhanced effect on fatness and fitness of girls compared to boys. Furthermore, the data suggest that children with the least favorable cardiometabolic risk profile and therefore most in need of change can benefit from school-based PA interventions. Trial registration number: Clinicaltrials.gov ID no.: NCT02132494.

Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT.

There is a need for interventions supporting patients with mental health conditions in coping with stigma and discrimination. A psycho-educational group therapy module to promote stigma coping and empowerment (STEM) was developed and tested for efficacy in patients with schizophrenia or depression. 30 clinical centers participated in a cluster-randomized clinical trial, representing a broad spectrum of mental health care settings: in-patient (acute treatment, rehabilitation), out-patient, and day-hospitals. As randomized, patients in the intervention group clusters/centers received an illness-specific eight sessions standard psychoeducational group therapy plus three specific sessions on stigma coping and empowerment ('STEM'). In the control group clusters the same standard psychoeducational group therapy was extended to 11 sessions followed by one booster session in both conditions. In total, N = 462 patients were included in the analysis (N = 117 with schizophrenia spectrum disorders, ICD-10 F2x; N = 345 with depression, ICD-10 F31.3-F31.5, F32-F34, and F43.2). Clinical and stigma-related measures were assessed before and directly after treatment, as well as after 6 weeks, 6 months, and 12 months (M12). Primary outcome was improvement in quality of life (QoL) assessed with the WHO-QOL-BREF between pre-assessment and M12 analyzed by mixed models and adjusted for pre-treatment differences. Overall, QoL and secondary outcome measures (symptoms, functioning, compliance, internalized stigma, self-esteem, empowerment) improved significantly, but there was no significant difference between intervention and control group. The short STEM module has proven its practicability as an add-on in different settings in routine mental health care. The overall increase in empowerment in both, schizophrenia and depression, indicates patients' treatment benefit. However, factors contributing to improvement need to be explored.The study has been registered in the following trial registers. ClinicalTrials.gov: https://register.clinicaltrials.gov/ Registration number: NCT01655368. DRKS: https://www.drks.de/drks_web/ Registration number: DRKS00004217.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

Happiness or hopelessness in late life: A cluster RCT of the 3L-Mind-Training programme among the institutionalized older people.

AIM: To explore the effectiveness of a new mental health promotion activities programme by including the criterion variables of happiness and depressive mood. DESIGN: A single-blinded, clustered, randomized and controlled trial. METHOD: A list consisting of the names of elderly residents was provided by the senior social worker at a geriatric institution. The participants recruited for the study were living on one of four different floors that had separate and non-interfering spaces and having comparable disabilities. The researchers randomly assigned residents on two floors as members of the intervention group; the other residents were considered the control group. The intervention groups attended 6 weeks of the 3L-Mind-Training programme, whereas the control group only engaged in regular health promotion activities. The mini version of the Chinese Happiness Inventory was adapted to measure happiness. The Geriatric Depression Scale short-form was used to measure depression in older people. A generalized estimating equation was used to analyse the short-term and durative effects. FINDINGS: The 126 residents included in the study were 65-97 years old, and 90% of the residents relied on wheelchairs. The intervention activities give significant immediate and durative effects both on subjective well-being enhancement and depressive mood relief. When evaluating the overall intervention activity, 93.8% of the aged residents indicated that this programme was helpful and allowed them to view life events positively. CONCLUSION AND IMPACT: A well-planned mind-training programme could help elderly people reform their viewpoint and create a more fun and happy experience of ageing. TRIAL REGISTRATION: Data were obtained from the project, initiated in 2014, which was funded by the Ministry of Science and Technology in Taiwan and was approved by the Institutional Review Board in Chung Shan Medical University (No. CS15009). The trial registration number of the study was No. ChiCTR1900021811.

A screen-based simulation training program to improve palliative care of people with advanced dementia living in residential aged care facilities and reduce hospital transfers: study protocol for the IMproving Palliative care Education and Training Using Simulation in Dementia (IMPETUS-D) cluster randomised controlled trial.

BACKGROUND: Many people with advanced dementia live in residential aged care homes. Care home staff need the knowledge and skills to provide high-quality end-of-life (EOL) dementia care. However, several studies have found EOL dementia care to be suboptimal, and care staff have reported they would benefit from training in palliative care and dementia. Simulation offers an immersive learning environment and has been shown to improve learners' knowledge and skills. However, there is little research on simulation training for residential care staff. This article presents the development and evaluation protocol of IMproving Palliative care Education and Training Using Simulation in Dementia (IMPETUS-D) - a screen-based simulation training program on palliative dementia care, targeted at residential care staff. IMPETUS-D aims to improve the quality of palliative care provided to people living with dementia in residential care homes, including avoiding unnecessary transfers to hospital. METHODS: A cluster RCT will assess the effect of IMPETUS-D. Twenty-four care homes (clusters) in three Australian cities will be randomised to receive either the IMPETUS-D intervention or usual training opportunities (control). The primary outcome is to reduce transfers to hospital and deaths in hospital by 20% over 6-months in the intervention compared to the control group. Secondary outcomes include uptake of goals of care plans over 6 and 12 months, change in staff knowledge and attitudes towards palliative dementia care over 6 months, change in transfers to hospital and deaths in hospital over 12 months. For the primary analysis logistic regression models will be used with standard errors weighted by the cluster effects. A mixed methods process evaluation will be conducted alongside the cluster RCT to assess the mechanisms of impact, the implementation processes and contextual factors that may influence the delivery and effects of the intervention. DISCUSSION: In Australia, the need for high-quality advanced dementia care delivered in residential aged care is growing. This study will assess the effect of IMPETUS-D a new simulation-based training program on dementia palliative and EOL care. This large multisite trial will provide robust evidence about the impact of the intervention. If successful, it will be distributed to the broader residential care sector. TRIAL REGISTRATION: ANZCTR, ACTRN12618002012257 . Registered 14 December 2018.

Pathways leading to success and non-success: a process evaluation of a cluster randomized physical activity health promotion program applying fuzzy-set qualitative comparative analysis.

BACKGROUND: Health promotion programs can only lead to improvements in health outcomes if they are effectively implemented. However, most studies assessing implementation success focus on only one condition, although more conditions influence this process. Therefore, evidence is scarce on what conditions play a role in successful implementation and how they interact. Hence, we aimed to identify which combinations of teacher and implementation process characteristics affected the emotional and social school experience (SCE) of pupils participating in a school-based health promotion program. METHODS: This study was part of an effectiveness and process evaluation including 24 intervention and 27 control classes. We used fuzzy-set qualitative comparative analysis (fsQCA) to identify combinations of conditions that were associated with either an increase or no increase in the outcome SCE in comparison to the control group at 20 months post intervention. We deductively selected five conditions based on the Consolidated Framework for Implementation Research: teachers' perceived self-efficacy, teachers' expectations of the benefits of the intervention, teachers' previous knowledge about the intervention, dosage of physical activity breaks, and quality of the implementation. RESULTS: We identified five different pathways that led to no increase in the pupils' outcome (parameters of fit: consistency 94%, coverage 66%). The combination of an unsatisfying quality of implementing the intervention and a low previous knowledge about the intervention showed the highest empirical relevance. Similarly, fewer physical activity breaks in combination with other conditions impeded the program's success. Furthermore, we identified two different pathways characterizing ways to success (consistency: 81%, coverage: 52%). The most relevant combination was good quality implementation of physical activity breaks, implemented by teachers with a high self-efficacy, and a good previous knowledge about the intervention. CONCLUSIONS: QCA has potential for an in-depth analysis of complex interventions as it can rely on small to medium sample sizes and analyze pathways to success and non-success separately. The investigated program can be improved by considering the following suggestions: The quality of the implementation process should be monitored during the implementation phase, and regular feedback loops and learning opportunities for teachers should accompany a program. Clear recommendations regarding the dosage should be established. TRIAL REGISTRATION: German register of clinical studies: DRKS00000622 . Retrospectively registered: December 3, 2010, ( http://www.drks.de/drks_web/setLocale_EN.do ). Approved by the Ethics Committee of Lower Austria (GS4-EK-4/107-2010).

What happened in the 'Move for Well-being in School': a process evaluation of a cluster randomized physical activity intervention using the RE-AIM framework.

BACKGROUND: The aim of this study was to address the gap in the translation of research into practice through an extensive process evaluation of the Move for Well-being in School programme using the RE-AIM framework. The purpose was to gain insight into the extent by which the intervention was adopted and implemented as intended and to understand how educators observed its effectiveness and maintenance. METHODS: Public schools located in seven municipalities in Denmark were invited to enroll their 4th to 6th grade classes in the project. Of these, 24 school decided to participate in the project in the school-year 2015-16 and were randomly (cluster) allocated to either intervention or control group. A process survey was completed online by school personnel at the start, at midterm, and at the end of the school year. Additionally, informal interviews and observations were conducted throughout the year. RESULTS: At the 12 intervention schools, a total of 148 educators were involved in the implementation of the programme over the school-year. More than nine out of ten educators integrated brain breaks in their lessons and practically all the physical education teachers used the physical education lesson plans. The educators delivered on average 4.5 brain breaks per week and up to 90% of the physical education teachers used the project lesson plans for at least half of their classes. Half of the educators initiated new recess activities. A total of 78%, 85% and 90% of the educators believed that the implemented recess, brain break and physical education components 'to a high degree' or 'to some degree' promoted the pupils' well-being, respectively. CONCLUSIONS: This study shows that it is possible to design a school-based PA intervention that educators largely adopt and implement. Implementation of the PA elements was stable throughout the school year and data demonstrate that educators believed in the ability of the intervention to promote well-being among the pupils. Finally, the study show that a structured intervention consisting of competence development, set goals for new practices combined with specific materials, and ongoing support, effectively reached a vast majority of all teachers in the enrolled schools with a substantial impact. TRIAL REGISTRATION: Date of registration: retrospectively registered on 24 April 2015 at Current Controlled Trials (DOI 0.1186/ ISRCTN12496336 - named: "The role of physical activity in improving the well-being of children and youth").

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.

BACKGROUND: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION: ISRCTN15811706.