Cluster-randomized Trial Research Articles

Effectiveness of Hospital Fit on Physical Activity in Hospitalized Patients: A Stepped-Wedge Cluster-Randomized Trial and Process Evaluation.

This study investigates the effectiveness of using Hospital Fit as part of usual care physiotherapy on the physical activity (PA) behavior of hospitalized patients compared to patients who received physiotherapy before implementation of Hospital Fit. In addition, a process evaluation is conducted. A prospective, multi-center, mixed-methods stepped wedge cluster randomized trial was performed at the cardiology and medical oncology departments of two Dutch university medical centers. Patients were included in the non-intervention or intervention phase. During the non-intervention phase, patients received usual care physiotherapy. During the intervention phase, Hospital Fit was additionally used. Mean time spent walking, standing, lying/sitting per day and the number of postural transitions from lying/sitting to standing/walking positions were measured using an accelerometer and analyzed using linear mixed models. A process evaluation was performed using questionnaires and semi-structured interviews with patients and focus-group interviews with healthcare professionals. A total of 77 patients were included, and data from 63 patients were used for data analysis. During the intervention phase, the average time spent walking per day was 20 min (95% confidence interval: -2 to 41 min) higher than during the non-intervention phase (p = 0.075). No significant differences were found for mean time spent standing per day, mean time spent lying/sitting per day, or the number of postural transitions per day either. During the intervention phase, 87% of patients used Hospital Fit at least once, with a median daily use of 2.5 to 4.0 times. Patients and healthcare professionals believed that Hospital Fit improved patients' PA behavior and recovery. Insufficient digital skills and technical issues were described as challenges. Although patients and healthcare professionals described Hospital Fit as an added value, no statistically significant effects were found.

The effectiveness of a knowledge translation intervention on the implementation of NEWS2 in nursing homes, a pragmatic cluster RCT

BackgroundImproving the uptake of relevant and reliable research is an important priority in long-term care to achieve sustainable and high-quality services for the increasingly older population.AimThe purpose was to assess the effectiveness of a tailored, adaptive and a multifaceted KT capacity program, relative to usual practice, on the implementation of National Early Warning Score 2 (NEWS2).MethodsThis study was carried out as a pragmatic cluster-randomized controlled trial. The capacity program consisted of an educational part to address implementation capacity gaps and a facilitation-upon-implementation part to address a relevant knowledge gap in nursing homes. A collective decision was made to address the challenge of early detection of clinical deterioration among nursing home residents, by implementing the (NEWS2) as clinical innovation.Public nursing homes in a Norwegian municipality (n = 21) with a total of 1 466 beds were eligible for inclusion. The study-period spanned over a 22-month period, including a 12-month follow-up.Data was extracted from the Electronic Patient Journal system and analyzed using multilevel growth model analysis.ResultsThe intervention had a large effect on the use of NEWS2 among care staff in intervention nursing homes, compared to the control group (standardized mean difference, d = 2.42). During the final month of the implementation period, residents in the intervention group was assessed with NEWS2 1.44 times (95% CI: 1.23, 1.64) per month, which is almost four times more often than in the control group (mean = 0.38, 95% CI: 0.19, 0.57). During the follow-up period, the effect of the intervention was not only sustained in the intervention group but there was a substantial increase in the use of NEWS2 in both the intervention (mean = 1.75, 95% CI: 1.55, 1.96) and control groups (mean = 1.45, 95% CI: 1.27, 1.65).ConclusionsThis tailored implementation strategy had a large effect on the use of NEWS2 among care staff, demonstrating that integrated knowledge translation strategies can be a promising strategy to achieve evidence-based care in the nursing home sector.Trial registrationISRCTN12437773. Registered 19/3 2020, retrospectively.

Effect of a Male-Targeted Digital Decision Support Application Aimed at Increasing Linkage to HIV Care Among Men: Findings from the HITS Cluster Randomized Clinical Trial in Rural South Africa.

Linkage to HIV care remains suboptimal among men. We investigated the effectiveness of a male-targeted HIV-specific decision support app, Empowering People through Informed Choices for HIV (EPIC-HIV), on increasing linkage to HIV care among men in rural South Africa. Home-Based Intervention to Test and Start (HITS) was a multi-component cluster-randomized controlled trial conducted among 45 communities in uMkhanyakude, KwaZulu-Natal. The development of EPIC-HIV was guided by self-determination theory and human-computer interaction design to increase intrinsic motivation to seek HIV testing and care among men. EPIC-HIV was offered in two stages: EPIC-HIV 1 at the time of home-based HIV counseling and testing (HBHCT), and EPIC-HIV 2 at 1 month after a positive HIV diagnosis if not linked to care. Sixteen communities were randomly assigned to the arms to receive EPIC-HIV, and 29 communities to the arms without EPIC-HIV. Among all eligible men, we compared linkage to care (initiation or resumption of antiretroviral therapy after > 3 months of care interruption) at local clinics within 1 year of a home visit, ascertained from individual clinical records. Intention-to-treat analysis was performed using modified Poisson regression with adjustment for receiving another intervention (i.e., financial incentives) and clustering at the community level. We also conducted a satisfaction survey for EPIC-HIV 2. A total of 13,894 men were eligible (i.e., aged ≥ 15 years and resident in the 45 communities). The mean age was 34.6 (±16.8) years, and 65% were married or in an informal union. Overall, 20.7% received HBHCT, resulting in 122 HIV-positive and 6 discordant tests. Among these, 54 men linked to care within 1 year after HBHCT. Additionally, of the 13,765 eligible participants who did not receive HBHCT or received HIV-negative results, 301 men linked to care within 1 year. Overall, only 13 men received EPIC-HIV 2. The proportion of linkage to care did not differ between the arms randomized to EPIC-HIV and those without EPIC-HIV (adjusted risk ratio = 1.05; 95% CI:0.86-1.29). All 13 men who used EPIC-HIV 2 reported the app was acceptable, user-friendly, and useful for getting information on HIV testing and treatment. The reach was low, although the acceptability and usability of the app were very high among those who engaged with it. Enhanced digital support applications could form part of interventions to increase knowledge of HIV treatment among men. Clinical Trial Number: ClinicalTrials.gov # NCT03757104.

Effectiveness of group-based psycho-education on preventing postpartum depression among pregnant women by primary healthcare provider in primary healthcare institution: a cluster-randomized controlled trial.

In Ethiopia, one in five mothers suffers from postpartum depression, which needs to be prevented through interventions. According to the World Health Organization, maternal healthcare providers have a unique opportunity to provide psychosocial interventions to prevent the damaging effects of perinatal depression. Hence, this study assessed the effectiveness of prenatal group-based psycho-education in preventing postpartum depression (PPD) in primary healthcare units. We conducted a two-arm cluster-randomized controlled trial, enrolling 550 pregnant women at 12-20 weeks of gestation with a normal score (0-4) and a mild score (5-9) on the Patient Health Questionnaire-9 (PHQ-9). The study utilized simple randomization techniques to assign clusters between arms in a 1:1 ratio. The data was collected through face-to-face interviews conducted at 12-20 weeks of gestation and 6 weeks postpartum. The intervention group received usual care plus five prenatal group-based psycho-education (PGBPE) classes, while the control group received only usual care. The PPD status between arms was compared using the chi-square test of association. A mixed-effects multilevel logistic regression model was also used to examine the predictors of the outcome variables. The overall response rate at the end line was 92.9%. Thus, compared to that in controls, the PPD in the intervention clusters was considerably lower (20 (7.6%) vs. 74 (28.9%)), P = 0.001)/65% (AOR = 0.35, 95% CI = 0.13-0.99), although no difference was detected at baseline. Social support (AOR = 0.04, 95% CI = 0.01-0.15), partner emotional support (AOR = 0.24, 95% CI = 0.12-0.51), PPD literacy (AOR = 0.25, 95% CI = 0.11-0.62), and self-esteem (AOR = 0.22, 95% CI = 0.11-0.47) were more likely to protect mothers from PPD. On the contrary, domestic work (AOR = 9.75, 95% CI = 3.37-28.16), neonates with complications (AOR = 5.79, 95% CI = 2.04-16.45), and unhealthy coping (AOR = 2.39, 95% CI = 1.06-5.42) exposed mothers to PPD. The implementation of a PGBPE in primary healthcare units (PHCUs) was effective at preventing PPD. Therefore, this intervention method has to be promoted and used in PHCUs to prevent PPD. [Pan African Clinical Trial Registry], identifier [PACTR 202203616584913].

Effectiveness of mobile smoking cessation treatment with 1-week nicotine replacement therapy sampling at outdoor smoking hotspots: A cluster randomized controlled trial.

To evaluate the effectiveness of mobile smoking cessation (SC) treatment with 1-week nicotine replacement therapy (NRT) sampling on recruitment and quitting outcomes. Two-arm cluster RCT (1:1 ratio), single-blinded, at 244 recruitment sessions in Hong Kong outdoor smoking hotspots from October 2018-December 2019. Participant were recruited by ambassadors and treated at the mobile SC truck. 834 adult (≥18 years, male 81.3%) daily smokers, Chinese-speaking, non-NRT users in the past month, consented after nurse-led intervention in mobile SC truck were randomized to the experimental (n = 482 male 79.5%) and the control group (n = 352, male 83.8%). The experimental group received a 1-week free NRT sample, an NRT instruction card, and mobile SC treatment including onsite nurse-led brief medication advice (about 15 minutes) and referral to SC clinics. The control group received the same mobile SC treatment. Primary outcome was self-reported quit attempts at 1-month follow-up. Secondary outcomes included SC service use at 1month, and biochemically validated abstinence (exhaled carbon monoxide < 4ppm; or saliva cotinine < 10ng/ml) at 6-month follow-up. Additionally, a post-hoc cost analysis was conducted. By intention-to-treat, the two groups showed similar prevalence of quit attempts (44·4% versus 43·5%, risk ratio (RR) = 1·04, 95% confidence interval (CI) = 0·79-1·37, P = 0·79). Compared with the control group, the experimental group showed lower SC service use at clinics (32·4% versus 44·9%, RR = 0·72, 95%CI = 0·57-0·91, P = 0·006), but no significant difference in validated abstinence (4·6% versus 2·8%, RR = 1·64, 95%CI = 0·76-3·50, P = 0·21). The experimental recruitment sessions recruited more smokers for onsite medication advice than the control session (mean 6·7 vs 5·0, adjusted incident rate ratio = 1·30, 95%CI = 1·08-1·56, P = 0·005). Mobile smoking cessation treatment with 1-week nicotine replacement therapy sampling did not increase quit attempts or abstinence outcomes among recruited daily smokers in Hong Kong. The intervention increased smokers' uptake of onsite medication advice but reduced subsequent smoking cessation service use at clinics.

The effects of a blended learning model on the physical fitness of Chinese university students: a cluster randomized controlled trial in basketball education

ObjectiveThe university period is a critical stage of personal development, and improving the physical fitness of university students is crucial to their academic performance, quality of life, and future. However, in recent years, the physical fitness level of Chinese university students has shown a decreasing trend. This study aimed to investigate the effects of a blended learning model on the physical fitness of Chinese university students through a 16-week intervention.MethodsA total of 78 first-year students from a public university in Henan Province were recruited for this study via a cluster randomized controlled trial (CRCT) design. The participants were divided into an experimental group (blended learning) and a control group (traditional learning). The intervention lasted for 16 weeks, and physical fitness indices such as body mass index (BMI), lung capacity, sit and reach, pull-ups/sit-ups, standing long jumps, 50-meter runs, and 1000/800-meter runs were measured before and after the intervention. Statistical analyses were conducted via generalized estimating equation (GEE) modeling, with the significance level set at P < 0.05.ResultsBoth learning models significantly improved students’ physical fitness after 16 weeks. However, the blended learning model resulted in more significant improvements in lung capacity, sit and reach, pull-ups/sit-ups, standing long jumps, and 50-meter runs (P < 0.05). No significant differences were found between the two groups in terms of BMI or 1000/800-meter run.ConclusionsThe 16-week blended learning model effectively promoted physical fitness among university students, especially in terms of their lung capacity, flexibility, strength and speed.

Head-to-head comparison of two human papillomavirus vaccines for efficacy against cervical intraepithelial neoplasia grade 3 and adenocarcinoma in situ-population-based follow-up of two cluster-randomized trials.

We report head-to-head comparison of the bivalent and quadrivalent HPV vaccine efficacies against immediate precursors of cervical cancer from 15 years' country-wide cancer registry follow-up of phase III trial cohorts and an age-aligned cohort of unvaccinated women. These individually and/or clusterrandomized cohorts of HPV6/11/16/18- and HPV16/18-vaccinated and unvaccinated women were enrolled, respectively, in 2002, 2004, and 2003/2005. The trial cohorts comprised initially 16- to 17-year-old HPV6/11/16/18-vaccinated FUTURE II (NCT00092534) participants (866) and HPV16/18-vaccinated PATRICIA (NCT00122681) and 012 trial (NCT00169494) participants (2,465), and 16,526 initially 16- to 19-year-old unvaccinated controls. After active 4-year clinical follow-up, passive, country-wide Finnish Cancer Registry (FCR) follow-up for cervical intraepithelial neoplasia grade 3 (CIN3) and adenocarcinoma in situ (AIS) was based on consented use of unique personal identifiers and started 6 months after the end of the FUTURE II and PATRICIA trials in 2007 and 2009, and ended at the end of 2019. The follow-up with altogether 229,020 follow-up years was age-aligned to ensure that similarly aged cohorts were passively followed up for 15 years post=vaccination for the intention-to-treat analyses of vaccine efficacy. Overall, we identified 5 and 16 CIN3 (no AIS) cases in the HPV6/11/16/18 and HPV16/18 cohorts, respectively, during the FCR-based follow-up. In the unvaccinated cohort, we identified 281 CIN3 cases, 20 AIS cases, and 13 cases with invasive cervical cancer. Vaccine efficacies against CIN3+ were 68.4% and 64.5% for the quadrivalent and the bivalent vaccines, respectively, with overlapping confidence intervals. Long-term follow-up of randomized, initially adolescent HPV-vaccinated and unvaccinated cohorts shows, in this head-to-head setting, that the bivalent and quadrivalent HPV vaccines are equally effective against immediate precursors of cervical cancer.

Effect of a comfort scale compared with a pain numerical rate scale on opioids consumption in postanaesthesia care unit: the COMFORT study

BackgroundThe way that pain is assessed in the PACU could impact on postoperative pain and analgesic consumption. However, there is currently no evidence to support this speculation. The authors hypothesised that using a comfort scale reduces postoperative opioid consumption when compared with a standard numerical rating scale (NRS) to evaluate pain in the PACU. MethodsIn this cluster-randomised trial, patients were assessed using either a comfort scale (comfort group) or a pain NRS (NRS group). The primary outcome was the opioid consumption in the PACU. The main secondary outcomes were postoperative pain, nausea and vomiting, length of stay in the PACU, and satisfaction. ResultsOf 885 randomised patients, 860 were included in the analysis. Opioid consumption in the PACU was comparable in the comfort and NRS groups (median [interquartile range [IQR] 0 (0–5) vs 0 (0–6); P=0.2436), irrespective of the type of surgical procedure. The majority of patients did not need any postoperative opioid (59% in the comfort group and 56% in the NRS group, P=0.2260). There was no difference in postoperative pain, nausea and vomiting, time to reach an Aldrete score ≥9 after extubation, and global satisfaction. ConclusionsUsing a comfort scale to assess pain in the PACU did not spare any opioid compared with use of a standard NRS. Further studies focusing on patients at risk of increased postoperative opioid consumption are necessary. Clinical trial registrationNCT05234216.

Update to the study protocol: minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): a multicentre, stepped-wedge, cluster-randomised controlled trial

This document reports a brief update to the previously published protocol of the MinDial study.Trial registration German Clinical Trials Register DRKS00029691. Registered on 12 Sept. 2022, https://drks.de/search/en/trial/DRKS00029691.

Effect of salt substitution on fracture—a secondary analysis of the Salt Substitute and Stroke Study (SSaSS)

BackgroundAssociations of dietary sodium and potassium intake with fracture risk are inconsistent and the effects of salt substitute on fracture incidence are unknown. We assessed the effect of salt substitute compared to regular salt intake on fracture incidence using data from the Salt Substitute and Stroke Study (SSaSS).MethodsSSaSS was a cluster-randomized controlled trial conducted in 600 villages in northern China. Villages were randomly allocated into intervention and control groups in a 1:1 ratio. Salt substitute was provided to intervention villages and control villages continued regular salt use for 5 years. The primary outcome for this secondary analysis was the incidence of all fractures. Secondary outcomes included incidence of vertebral fracture, non-vertebral fracture, and fracture of unknown or non-specific location.Results20,995 participants were included in this study, and 821 fractures occurred during follow-up. Intention-to-treat analyses showed no differences between the salt substitute and regular salt groups in the incidence of all fractures (rate ratio (RR) 0.96; 95% CI 0.81 to 1.14), vertebral fracture (RR 0.82; 95% CI 0.53 to 1.26), non-vertebral fracture (RR 1.05; 95% CI 0.86 to 1.29), or fracture of unknown or non-specific location (RR 0.80; 95% CI 0.54 to 1.18).ConclusionsUse of salt substitute compared to regular salt had no detectable effect on the incidence of fracture in a population at high risk of cardiovascular disease and fracture.Trial registrationClinicalTrials.gov, NCT02092090. Registered on March 12, 2014.

Structured diabetes care routines in cardiac rehabilitation are associated with increased diabetes detection and improved treatment after myocardial infarction: a nationwide observational study

BackgroundDespite the detrimental impact of abnormal glucose metabolism on cardiovascular prognosis after myocardial infarction (MI), diabetes is both underdiagnosed and undertreated. We investigated associations between structured diabetes care routines in cardiac rehabilitation (CR) and detection and treatment of diabetes at one-year post-MI.MethodsCenter-level data was derived from the Perfect-CR survey, which evaluated work routines applied at Swedish CR centers (n = 76). Work routines involving diabetes care included: (1) routine assessment of fasting glucose and/or HbA1c, (2) routine use of oral glucose tolerance test (OGTT), (3) having regular case rounds with diabetologists, and (4) whether glucose-lowering medication was adjusted by CR physicians. Patient-level data was obtained from the national MI registry SWEDEHEART (n = 7601, 76% male, mean age 62.6 years) and included all post-MI patients irrespective of diabetes diagnosis. Using mixed-effects regression we estimated differences between patients exposed versus. not exposed to the four above-mentioned diabetes care routines. Outcomes were newly detected diabetes and the proportion of patients receiving oral glucose-lowering medication at one-year post-MI.ResultsRoutine assessment of fasting glucose/HbA1c was performed at 63.2% (n = 48) of the centers, while 38.2% (n = 29) reported using OGTT for detecting glucose abnormalities. Glucose-lowering medication adjusted by CR physicians (n = 13, 17.1%) or regular case rounds with diabetologists (n = 7, 9.2%) were less frequently reported. In total, 4.0% of all patients (n = 304) were diagnosed with diabetes during follow-up and 17.9% (n = 1361) were on oral glucose-lowering treatment one-year post-MI. Routine use of OGTT was associated with a higher rate of newly detected diabetes at one-year (risk ratio [95% confidence interval]: 1.62 [1.26, 1.98], p = 0.0007). At one-year a higher proportion of patients were receiving oral glucose-lowering medication at centers using OGTT (1.22 [1.07, 1.37], p = 0.0046) and where such medication was adjusted by CR physicians (1.31 [1.06, 1.56], p = 0.0155). Compared to having none of the structured diabetes care routines, the more routines implemented the higher the rate of newly detected diabetes (from 0 routines: 2.7% to 4 routines: 6.3%; p for trend = 0.0014).ConclusionsHaving structured routines for diabetes care implemented within CR can improve detection and treatment of diabetes post-MI. A cluster-randomized trial is warranted to ascertain causality.

Impact of a school-based water and hygiene intervention on child health and school attendance in Addis Ababa, Ethiopia: a cluster-randomised controlled trial

BackgroundSchool-based water, sanitation and hygiene (WASH) may improve the health and attendance of schoolchildren, particularly post-menarcheal girls, but existing evidence is mixed. We examined the impact of an urban school-based WASH programme (Project WISE) on child health and attendance.MethodsThe WISE cluster-randomised trial, conducted in 60 public primary schools in Addis Ababa, Ethiopia over one academic year, enrolled 2–4 randomly selected classes per school (~ 100 pupils) from grades 2 to 8 (aged 7–16) in an ‘open cohort’. Schools were assigned 1:1 by stratified randomisation to receive the intervention during the 2021/2022 or the 2022/2023 academic year (waitlist control). The intervention included improvements to drinking water storage, filtration and access, handwashing stations and behaviour change promotion. Planned sanitation improvements were not realised. At four unannounced classroom visits post-intervention (March–June 2022), enumerators recorded primary outcomes of roll-call absence, and pupil-reported respiratory illness and diarrhoea in the past 7 days among pupils present. Analysis was by intention-to-treat.ResultsOf 83 eligible schools, 60 were randomly selected and assigned. In total, 6229 eligible pupils were enrolled (median per school 101.5; IQR 94–112), 5987 enrolled at study initiation (23rd November–22nd December 2021) and the remaining 242 during follow-up. Data were available on roll-call absence for 6166 pupils (99.0%), and pupil-reported illness for 6145 pupils (98.6%). We observed a 16% relative reduction in odds of pupil-reported respiratory illness in the past 7 days during follow-up in intervention vs. control schools (aOR 0.84; 95% CI 0.71–1.00; p = 0.046). There was no evidence of effect on pupil-reported diarrhoea in the past 7 days (aOR 1.15; 95% CI 0.84–1.59; p = 0.39) nor roll-call absence (aOR 1.07; 95% 0.83–1.38; p = 0.59). There was a small increase in menstrual care self-efficacy (aMD 3.32 on 0–100 scale; 95% CI 0.05–6.59), and no evidence of effects on other secondary outcomes.ConclusionsThis large-scale intervention to improve school WASH conditions city-wide had a borderline impact on pupil-reported respiratory illness but no effect on diarrhoeal disease nor pupil absence. Future research should establish relationships between WASH-related illness, absence and other educational outcomes.Trial registrationClinicalTrials.gov, number NCT05024890.

Effectiveness of a minecraft education intervention for improving spatial thinking in primary school children: A mixed methods two-level cluster randomised trial

BackgroundSpatial thinking plays a crucial role in STEM success. Minecraft Education, a digital game-based learning platform, provides opportunities for developing students’ spatial thinking while supporting curricular content. AimThis study evaluated the effectiveness of a Minecraft Education intervention, integrated into the curriculum, in improving spatial thinking and creativity. SampleFifth and sixth year primary school students (Mage = 11.53, SDage = 0.58) and their teachers. MethodsThe study used a mixed-methods, two-level cluster randomised-controlled trial design. Thirty-two classes (N = 885 students) were randomly assigned to the intervention or education-as-usual control group. Assessments of spatial thinking and creativity were completed at pre-test, post-test and 6-week follow up. Teacher interviews were conducted to understand their experiences of the intervention. ResultsWhile no overall intervention-related improvements in spatial thinking were found, subgroup analyses revealed that 5th year demonstrated improved spatial thinking compared to 6th year at post-test. This may be attributable to 5th year students’ higher levels of engagement in the intervention. Unexpectedly, creativity scores were higher in the control group at post-test. Qualitative interviews identified four themes: 1) Improving spatial thinking, 2) Improving creativity, 3) Engagement, and 4) Difficulties implementing the programme. ConclusionThis study highlights the importance of increasing student engagement in spatial interventions to improve their spatial skills. Finally, the study suggests that sustained practice is required to maintain the benefits of spatial instruction/training.

Effects of physically active maths lessons on children's maths performance and maths-related affective factors: Multi-arm cluster randomized controlled trial.

Physical activity (PA) may benefit academic performance, but it is unclear what kind of classroom-based PA is optimal for learning. We studied the effects of physically active maths lessons on children's maths performance and maths-related effects, and whether gender and previous mathematical or motor skills modify these effects. A total of 22 volunteered teachers and their pupils with signed consent (N = 397, mean age: 9.3 years, 51% females) participated in a 5-month, teacher-led, multi-arm, cluster-randomized controlled trial. The intervention included a PAL group (20 min of physically active learning in each 45-min lesson), a breaks group (two 5-min PA breaks in each 45-min lesson) and a control group (traditional teaching). Maths performance was assessed with a tailored curriculum-based test. Maths-related enjoyment, self-perceptions and anxiety were measured with a self-reported questionnaire. The individual-level intervention effects were tested via covariate-adjusted linear mixed-effect models with school classes serving as random effects. Changes in maths performance or self-perceptions did not differ between the intervention groups. Maths anxiety in learning situations increased in the PAL group (effect .28, 95% CI = .01-.56); there was no change in the other groups. Subgroup analyses suggested that maths anxiety increased in the PAL group among children in the two lowest tertiles of motor skills. It decreased in the highest tertile. Enjoyment decreased in the breaks group among pupils in the lowest motor skill tertile. Physically active maths lessons did not affect maths performance or self-perceptions but had divergent effects on maths anxiety and enjoyment, depending on motor skills.

P041 COMMUNITY-BASED STRATEGIES TO IMPROVE HEALTH-RELATED OUTCOMES IN PEOPLE LIVING WITH HYPERTENSION IN LOW MIDDLE-INCOME COUNTRIES: A SYSTEMATIC REVIEW AND META-ANALYSIS

Background and objective: Hypertension affects one billion people globally and is a major risk factor for cardiovascular diseases. Currently, it is estimated that high blood pressure (BP) is related to the deaths of more than 10 million people every year. Interventions to mitigate the looming hypertension crisis in low- and middle-income countries (LMIC) need strong community involvement whilst concurrently addressing access to care and quality of care issues. The objective of this systematic review was to evaluate community-level interventions to improve hypertension control among patients living in LMICs. Methods: Nine databases were searched (July 22, 2023) for randomized controlled trials (RCTs) and cluster randomized control trials (cRCTs) implementing community-level interventions in adults with hypertension in LMICs. Studies were included based on an explicit focus on BP control. Quality assessment was done using the Revised Cochrane Risk of Bias tool for randomized trials (ROBS 2). Results were presented following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. Fixed-effect meta-analysis were conducted for studies that reported continuous outcome measures. Results: We identified and screened 7125 articles. Eighteen studies were included in the analysis, 7 RCTs and 11 cRCTs. The overall summary effect of BP control from the meta-analysis was significant, risk ratio = 1.48 (95%CI = 1.40–1.57, n=12). For the RCTs risk ratio was 1.68 (95%CI = 1.40–2.01, n=5), and for the cRCTs 1.46 (95% CI = 1.32 – 1.61, n=7). For studies that reported on the individual components of the composite interventions, the risk ratio was 1.27 (95%CI = 1.04–1.54, n=3). Conclusions: Community-based strategies are relevant in addressing the burden of hypertension in LMICs. Community-based interventions can help decentralize hypertension care in LMIC and address the access to care gap without diminishing the quality of hypertension control.

Enhancing Physical Fitness in Elite Field Hockey Players with A Twelve-Week Functional Training Program: A Cluster Randomized Control Trial.

This study aimed to explore the impact of functional training on the physical fitness of young elite field hockey players. The study comprised 40 young elite male field hockey players with the following characteristics (mean ± SD age: 21.5 ± 0.8 years; height: 176.9 ± 2.6 cm; weight: 68.4 ± 5.1 kg; BMI: 21.8 ± 1.3; training experience: 51.2 ± 5.4 months). Twenty participants were allocated to two groups: the functional training group (FTG) and the control training group (CG). Each group received 60-minute training sessions three times per week for 12 weeks. Generalized estimating equation analysis and a Bonferroni test for pairwise comparisons were used to assess the intervention's efficacy. Before the start of the exercise program, no statistically significant differences were observed in physical fitness measures between the FTG and CG (p > 0.05). However, by the sixth week, a significant difference appeared in both the T-Agility test (p < 0.001) and endurance (p = 0.024) between the two groups, while no notable distinctions were detected in other fitness parameters (p > 0.05). After a 12-week training program, the FTG demonstrated improvements in all physical fitness measures [flexibility (p < 0.001); Illinois agility test (p < 0.001); T-agility test (p = 0.020); endurance (p < 0.001)] except speed, which exhibited no significant impact (p = 0.175). Notable enhancements in T-agility and endurance were evident after just six weeks of functional training, and a 12-week functional training regimen showed superiority over standard training approaches in young elite male field hockey players. These findings encourage the efficacy of functional training exercises over traditional methods in enhancing athletes' fitness parameters.

The effectiveness of evidence-based healthcare educational interventions on healthcare professionals' knowledge, skills, attitudes, professional practice and healthcare outcomes: Systematic review and meta-analysis.

The primary aim of this systematic review is to assess the effectiveness of evidence-based healthcare (EBHC) educational interventions on healthcare professionals' knowledge, skills, attitudes, behaviour of EBHC, clinical process and care outcomes. A secondary aim of the review is to assess the effects of important pedagogical moderating factors for EBHC educational interventions. This systematic review used a forward and backward citation search strategy on the Web of Science platform (date of inception to 28 April 2023). Only randomised controlled trials (RCTs) and cluster RCTs which compared EBHC educational interventions for healthcare professionals were included. A random effects meta-analysis was undertaken for EBHC compared with an active and nonactive control for all outcomes. Sixty-one RCTs were identified which included a total of 5208 healthcare professionals. There was a large effect for EBHC educational interventions compared with waiting list/no treatment/sham control on knowledge (SMD, 2.69; 95% CI, 1.26-4.14, GRADE Low), skills (SMD, 0.88; 95% CI, 0.25-1.73, Very Low Certainty), attitude (SMD, 0.81; 95% CI, 0.16-1.47, Very Low Certainty) and behaviour of EBHC (SMD, 0.82; 95% CI, 0.25-1.40, Very Low Certainty). Over time the effect of EBHC educational interventions substantially decreased with no evidence of effect at 6 months for any outcome except behaviour (SMD,1.72; 95% CI, 0.74-2.71, Low Certainty). There was some evidence that blended learning, active learning and consistency in the individual delivering the intervention may be important positive moderating factors. These findings suggest that EBHC educational interventions may have a large short-term effect on improving healthcare professionals' knowledge, skills, attitude and behaviour of EBHC. These effects may be longer-lasting regarding EBHC behaviour. In terms of pedagogy, blended learning, active learning, and consistency of the individual delivering the intervention may be important positive moderating factors.

Home visits versus fixed-site care by community health workers and child survival: a cluster-randomized trial, Mali.

To test the effect of proactive home visits by trained community health workers (CHWs) on child survival. We conducted a two arm, parallel, unmasked cluster-randomized trial in 137 village-clusters in rural Mali. From February 2017 to January 2020, 31 761 children enrolled at the trial start or at birth. Village-clusters received either primary care services by CHWs providing regular home visits (intervention) or by CHWs providing care at a fixed site (control). In both arms, user fees were removed and primary health centres received staffing and infrastructure improvements before trial start. Using lifetime birth histories from women aged 15-49 years surveyed annually, we estimated incidence rate ratios (IRR) for intention-to-treat and per-protocol effects on under-five mortality using Poisson regression models. Over three years, we observed 52 970 person-years (27 332 in intervention arm; 25 638 in control arm). During the trial, 909 children in the intervention arm and 827 children in the control arm died. The under-five mortality rate declined from 142.8 (95% CI: 133.3-152.9) to 56.7 (95% CI: 48.5-66.4) deaths per 1000 live births in the intervention arm; and from 154.3 (95% CI: 144.3-164.9) to 54.9 (95% CI: 45.2-64.5) deaths per 1000 live births in the control arm. Intention-to-treat (IRR: 1.02; 95% CI: 0.88-1.19) and per-protocol estimates (IRR: 1.01; 95% CI: 0.87-1.18) showed no difference between study arms. Though proactive home visits did not reduce under-five mortality, system-strengthening measures may have contributed to the decline in under-five mortality in both arms.

796. P02.05 NEOADJUVANT CHEMORADIOTHERAPY FOLLOWED BY ACTIVE SURVEILLANCE VERSUS STANDARD SURGERY FOR OESOPHAGEAL CANCER (SANO-TRIAL): A MULTICENTRE STEPPED-WEDGE CLUSTER-RANDOMISED NONINFERIORITY TRIAL

Abstract Background One of the standard treatments for patients with locally advanced oesophageal cancer is neoadjuvant chemoradiotherapy followed by oesophagectomy. Of these patients, 29% have a pathologically complete response. Active surveillance may be an alternative for patients with clinically complete response (i.e. no residual tumour detected using clinical response evaluations). Methods A multicentre stepped-wedge cluster-randomised noninferiority trial was performed in twelve Dutch hospitals. Patients with a clinically complete response were included, determined with endoscopic biopsies, endoscopic ultrasound with fine-needle aspiration and PET-CT. Afterwards, patients underwent active surveillance or standard surgery. Primary endpoint was overall survival, which was analysed according to modified intention-to-treat (allowing cross-over at time of clinically complete response), traditional intention-to-treat and according to histology. Noninferiority was defined as two-year survival rate for active surveillance 15% below standard surgery. Results Between November 8, 2017 and January 17, 2021, 1115 patient were screened of whom 309 patients were included, 198 underwent active surveillance and 111 standard surgery. Two-year overall survival for active surveillance was noninferior to standard surgery (3% higher, 95% upper boundary 7% lower). There were no significant differences in overall survival according to modified intention-to-treat analysis (HR:1.14, 95%CI:0.74–1.78, p=0.55), traditional intention-to-treat analysis (HR:0.83, 95%CI:0.53–1.31, p=0.42) or in the analysis according to histology. Eighty-three patients from the active surveillance group underwent postponed surgery with postoperative complications and radicality comparable to standard surgery. Sixty-nine patients had persistent CCR and 22 patients developed distant metastases within six months, prior to surgery. Median disease-free survival for active surveillance was 35 (95%CI 28–NR) versus 49 months (95%CI 31–NR) for standard surgery (HR1.25, 95%CI:0.83–1.89,p=0.29). Health-related quality of life was better at six and nine months for active surveillance. Conclusion Overall survival following active surveillance for oesophageal cancer is noninferior compared to standard surgery after two years. Postponed oesophagectomy for locoregional regrowth appeared safe. Of 198 patients who underwent active surveillance, 91 patients (46%) had been spared oesophagectomy, resulting in improved HRQOL. For the long-term efficacy of active surveillance, extended follow-up is required.

Abstract P332: High Shared Decision-Making Scores Associated with Blood Pressure Control: The Office Guidelines Applied to Practice (Office-GAP) IMPACT Program

Introduction: Cardiovascular disease (CVD) mortality is higher in people with diabetes mellitus due to the increased prevalence of CVD risk factors. The Office-Gap IMPACT Program (Office-Guidelines Applied to Practice Improving Diabetic Patients’ Adherence to Treatment and Prevention of Cardiovascular Disease) is a patient activation cluster-randomized trial (intervention: Office-GAP + text vs. control: text alone) seeking to improve communication and patient-provider partnerships through patient and provider training in shared decision-making (SDM), use of a guideline-based checklist, and text messaging to improve medication adherence in Federally Qualified Health Care Centers. Hypothesis: We assessed the hypothesis that individual level demographic and clinical characteristics of patients enrolled in Office-GAP IMPACT would be associated with patient-reported SDM using the CollaboRATE 3-item instrument, which measures three core SDM domains: (1) explanation of health issues, (2) elicitation of patient preferences and (3) integration of patient preferences into decisions with a 10-point response scale for each domain ranging from 0 “No effort was made” to 9 “Every effort was made.” Methods: The CollaboRATE was completed three months after baseline. A top-scoring method (a rating of 9 for all three items) was used to dichotomize CollaboRATE responses into two categories - participants who reported the highest levels of SDM on each of the three items versus those who did not. Accounting for the cluster-randomized design, generalized estimating equations (GEEs) were used to compare demographics and baseline factors that may be associated with the outcome. Results: A total of 288 patients were enrolled (intervention, N=158 and control, N=130). Among those with non-missing CollaboRATE scores, 152 (73% ± 3%) had high SDM. The inverse probability of non-missing weighting method was used to account for the missing data in CollaboRATE. Results from the weighted univariable models suggested older patients, history of smoking, and those with BP under control (&lt; 140/90 mmHg) at baseline were more likely to be satisfied with the SDM process. In multivariable logistic regressions, only BP control was statistically significant after adjusting for other factors. Conclusions: In conclusion, participants with BP control had higher SDM scores, which could lead to better health outcomes. Providers should include the practice of SDM principles in every clinical encounter.