scholarly journals Protocol for a prospective, cluster randomized trial to evaluate routine and deferred dialysis initiation (RADDI) in Chinese population

2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Xinju Zhao ◽  
Pei Wang ◽  
Lining Wang ◽  
Xiaonong Chen ◽  
Wen Huang ◽  
...  
Keyword(s):  
Chinese Population ◽  
Heart Function ◽  
Controlled Trial ◽  
Dialysis Initiation ◽  
Trial Registration ◽  
Optimal Timing ◽  
Asymptomatic Patients ◽  
All Cause Mortality ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background The timing of when to initiate dialysis for progressive chronic kidney disease (CKD) patients has not been well established. There has been a strong trend for early dialysis initiation for these patients over the past decades. However, the perceived survival advantage of early dialysis has been questioned by a series of recent observational studies. The only randomized controlled trial (RCT) research on this issue found the all-cause mortality, comorbidities, and quality of life showed no difference between early and late dialysis starters. To better understand optimal timing for dialysis initiation, our research will evaluate the efficacy and safety of deferred dialysis initiation in a large Chinese population. Methods The trial adopts a multicenter, cluster randomized, single-blind (outcomes assessor), and endpoint-driven design. Eligible participants are 18–80 years old, in stable CKD stages 4–5 (eGFR > 7 ml/min /1.73 m2), and with good heart function (NYHA grade I or II). Participants will be randomized into a routine or deferred dialysis group. The reference eGFR at initiating dialysis for asymptomatic patients is 7 ml/min /1.73 m2 (routine dialysis group) and 5 ml/min/1.73 m2 or less (deferred dialysis group) in each group. The primary endpoint will be the difference of all-cause mortality and acute nonfatal cerebro-cardiovascular events between the two groups. The secondary outcomes include hospitalization rate and other safety indices. The primary and secondary outcomes will be analyzed by appropriate statistical methods. Discussion This study protocol represents a large, cluster randomized study evaluating deferred and routine dialysis intervention for an advanced CKD population. The reference eGFR to initiate dialysis for both treatment groups is targeted at less than 7 ml/min/1.73m2. With this design, we aim to eliminate lead-time and survivor bias and avoid selection bias and confounding factors. We acknowledge that the study has limitations. Even so, given the low-targeted eGFR values of both arms, this study still has potential economic, health, and scientific implications. This research is unique in that such a low targeted eGFR value has never been studied in a clinical trial. Trial registration The trial has been approved by ClinicalTrials.gov (Trial registration ID NCT02423655). The date of registration was April 22, 2015.

scholarly journals Facilitating advance care planning in the general practice setting for patients with a chronic, life-limiting illness: protocol for a phase-III cluster-randomized controlled trial and process evaluation of the ACP-GP intervention

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Julie Stevens ◽  
Peter Pype ◽  
Kim Eecloo ◽  
Luc Deliens ◽  
Koen Pardon ◽  
...  
Keyword(s):  
General Practice ◽  
Process Evaluation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Phase Iii ◽  
Practice Setting ◽  
Randomized Controlled ◽  
Advance Care ◽  
Secondary Outcomes ◽  
Cluster Randomized

Abstract Background Advance care planning (ACP), a process of communication about patients’ preferences for future medical care, should be initiated in a timely manner. Ideally situated for this initiation is the general practitioner (GP). The intervention to improve the initiation of ACP for patients with a chronic life-limiting illness in general practice (ACP-GP) includes an ACP workbook for patients, ACP communication training for GPs, planned ACP conversations, and documentation of ACP conversation outcomes in a structured template. We present the study protocol of a Phase-III randomized controlled trial (RCT) of ACP-GP that aims to evaluate its effects on outcomes at the GP, patient, and surrogate decision maker (SDM) levels; and to assess the implementation process of the intervention. Methods This RCT will take place in Flanders, Belgium. Thirty-six GPs, 108 patients with a chronic, life-limiting illness, and their (potential) SDM will be recruited, then cluster-randomized to the ACP-GP intervention or the control condition. The primary outcome for GPs is ACP self-efficacy; primary outcome for patients is level of ACP engagement. Secondary outcomes for GPs are ACP practices, knowledge and attitudes; and documentation of ACP discussion outcomes. Secondary outcomes for patients are quality of life; anxiety; depression; appointment of an SDM; completion of new ACP documents; thinking about ACP; and communication with the GP. The secondary outcome for the SDM is level of engagement with ACP. A process evaluation will assess the recruitment and implementation of the intervention using the RE-AIM framework. Discussion While the general practice setting holds promise for timely initiation of ACP, there is a lack of randomized trial studies evaluating the effectiveness of ACP interventions implemented in this setting. After this Phase-III RCT, we will be able to present valuable evidence of the effects of this ACP-GP intervention, with the potential for offering a well-tested and evaluated program to be implemented in general practice. The results of the process evaluation will provide insight into what contributes to or detracts from implementation success, as well as how the intervention can be adapted to specific contexts or needs. Trial registration Prospectively registered at with ISRCTN (ISRCTN12995230); registered 19/06/2020.

scholarly journals eRegCom – Quality Improvement Dashboard for healthcare providers and Targeted Client Communication to pregnant women using data from an electronic health registry to improve attendance and quality of antenatal care: study protocol for a multi-arm cluster randomized trial

2020 ◽  
Author(s):  
Kjersti Mørkrid ◽  
Binyam Bogale ◽  
Eatimad Abbas ◽  
Khadija Abu Khader ◽  
Itimad Abu Ward ◽  
...  
Keyword(s):  
Quality Improvement ◽  
Antenatal Care ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Health Systems Strengthening ◽  
Trial Registration ◽  
Client Communication ◽  
Cluster Randomized

Abstract Background: This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targeted Client Communication (TCC) via short message service (SMS) to clients. The aim is to assess the effectiveness of the automated communication strategies from the eRegistry on improving attendance and quality of care for pregnant women.Methods: This four-arm cluster randomized controlled trial will be conducted in the West Bank and the Gaza Strip, Palestine, and includes 138 clusters (primary healthcare clinics) enrolling from 45 to 3000 pregnancies per year. The intervention tools are the QID and the TCC via SMS, automated from the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker. The primary outcomes are appropriate screening and management of anemia, hypertension, and diabetes during pregnancy; and timely attendance to antenatal care. Primary analysis, at the individual-level taking the design effect of the clustering into account, will be done as intention-to-treat.Discussion: This trial, embedded in the implementation of the eRegistry in Palestine, will inform the use of digital health interventions as a health systems strengthening approach.Trial registration: ISRCTN, trial registration number: 10520687, registered 18 October 2018, http://www.isrctn.com/ISRCTN10520687

scholarly journals Targeting the Infant Gut Microbiota Through a Perinatal Educational Dietary Intervention: Protocol for a Randomized Controlled Trial

10.2196/14771 ◽  
2019 ◽  
Vol 8 (10) ◽  
pp. e14771 ◽  
Author(s):  
Samantha L Dawson ◽  
Jeffrey M Craig ◽  
Gerard Clarke ◽  
Mohammadreza Mohebbi ◽  
Phillip Dawson ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Early Life ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Noncommunicable Disease ◽  
Trial Registration ◽  
Randomized Controlled ◽  
Study Results ◽  
Secondary Outcomes

Background The early life gut microbiota are an important regulator of the biological pathways contributing toward the pathogenesis of noncommunicable disease. It is unclear whether improvements to perinatal diet quality could alter the infant gut microbiota. Objective The aim of this study is to assess the efficacy of a perinatal educational dietary intervention in influencing gut microbiota in mothers and infants 4 weeks after birth. Methods The Healthy Parents, Healthy Kids randomized controlled trial aimed to recruit 90 pregnant women from Melbourne, Victoria, Australia. At week 26 of gestation, women were randomized to receive dietary advice from their doctor (n=45), or additionally receive a dietary intervention (n=45). The intervention included an educational workshop and 2 support calls aiming to align participants’ diets with the Australian Dietary Guidelines and increase intakes of prebiotic and probiotic foods. The educational design focused on active learning and self-assessment. Behavior change techniques were used to support dietary adherence, and the target behavior was eating for the gut microbiota. Exclusion criteria were age under 18 years, diagnosed mental illnesses, obesity, diabetes mellitus, diagnosed bowel conditions, exclusion diets, illicit drug use, antibiotic use, prebiotic or probiotic supplementation, and those lacking dietary autonomy. The primary outcome measure is a between-group difference in alpha diversity in infant stool collected 4 weeks after birth. Secondary outcomes include evaluating the efficacy of the intervention in influencing infant and maternal stool microbial composition and short chain fatty acid concentrations, epigenetic profile, and markers of inflammation and stress, as well as changes in maternal dietary intake and well-being. The study and intervention feasibility and acceptance will also be evaluated as secondary outcomes. Results The study results are yet to be written. The first participant was enrolled on July 28, 2016, and the final follow-up assessment was completed on October 11, 2017. Conclusions Data from this study will provide new insights regarding the ability of interventions targeting the perinatal diet to alter the maternal and infant gut microbiota. If this intervention is proven, our findings will support larger studies aiming to guide the assembly of gut microbiota in early life. Trial Registration Australian Clinical Trials Registration Number ACTRN12616000936426; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370939 International Registered Report Identifier (IRRID) DERR1-10.2196/14771

scholarly journals Effectiveness of a Yoga-Based Lifestyle Protocol (YLP) in Preventing Diabetes in a High-Risk Indian Cohort: A Multicenter Cluster-Randomized Controlled Trial (NMB-Trial)

2021 ◽  
Vol 12 ◽  
Author(s):  
Nagarathna Raghuram ◽  
Venkat Ram ◽  
Vijaya Majumdar ◽  
Rajesh SK ◽  
Amit Singh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Sample Size ◽  
Risk Reduction ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Trial Registration ◽  
Randomized Controlled ◽  
Cluster Randomized

IntroductionThough several lines of evidence support the utility of yoga-based interventions in diabetes prevention, most of these studies have been limited by methodological issues, primarily sample size inadequacy. Hence, we tested the effectiveness of yoga-based lifestyle intervention against diabetes risk reduction in multicentre, large community settings of India, through a single-blind cluster-randomized controlled trial, Niyantrita Madhumeha Bharat Abhiyan (NMB). Research Design and MethodsNMB-trial is a multicentre cluster-randomized trial conducted in 80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks)] randomly assigned in a 1:1 ratio to intervention and control groups. Participants were individuals (age, 20–70 years) with prediabetes (blood HbA1c values in the range of 5.7–6.4%) and IDRS ≥ 60. The intervention included the practice of yoga-based lifestyle modification protocol (YLP) for 9 consecutive days, followed by daily home and weekly supervised practices for 3 months. The control cluster received standard of care advice for diabetes prevention. Statistical analyses were performed on an intention-to-treat basis, using available and imputed datasets. The primary outcome was the conversion from prediabetes to diabetes after the YLP intervention of 3 months (diagnosed based upon HbA1c cutoff >6.5%). Secondary outcome included regression to normoglycemia with HbA1c <5.7%.ResultsA total of 3380 (75.96%) participants were followed up at 3 months. At 3 months post-intervention, overall, diabetes developed in 726 (21.44%) participants. YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55–69.85). The YLP also accelerated regression to normoglycemia [adjusted Odds Ratio (adjOR) = 1.20 (95% CI, 1.02–1.43)]. Importantly, younger participants (≤40 years) were found to regress to normoglycemia more effectively than the older participants Pinteraction<0.001. ConclusionBased on the significant risk reduction derived from the large sample size, and the carefully designed randomized yoga-based intervention on high-risk populations, the study is a preliminary but strong proof-of-concept for yoga as a potential lifestyle-based treatment to curb the epidemic of diabetes. The observed findings also indicate a potential of YLP for diabetes prevention in low/moderate risk profile individuals that needs large-scale validation.Trial RegistrationClinical Trial Registration Number: CTRI/2018/03/012804.

Does Early Artificial Rupture of Membranes Speed Labor in Preterm Inductions?

2017 ◽  
Vol 35 (08) ◽  
pp. 716-720 ◽  
Author(s):  
Spencer Kuper ◽  
Victoria Jauk ◽  
Sima Baalbaki ◽  
Alan Tita ◽  
Lorie Harper ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Care Center ◽  
Tertiary Care ◽  
Adverse Outcomes ◽  
Optimal Timing ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Observational Cohort ◽  
Secondary Outcomes ◽  
The Impact

Objective In full-term patients, early artificial rupture of membranes (AROMs) decreases time in labor. We assessed the impact of early AROM in preterm patients undergoing indicated induction of labor. Study Design We conducted a retrospective cohort study of all patients undergoing indicated preterm induction (23–34 weeks) at a single tertiary care center from 2011 to 2014. Early AROM was defined as <4 cm and late AROM was defined as ≥4 cm. The primary outcomes evaluated were cesarean delivery and time in labor. Secondary outcomes were chorioamnionitis and a composite of maternal and neonatal adverse outcomes. Results Of the 149 women included, 65 (43.6%) had early AROM. Early AROM was associated with an increased time from the start of induction to delivery (25.7 ± 13.0 vs. 19.0 ± 10.3 hours, p < 0.01) and with an increase in the risk of cesarean (53.4 vs. 22.6%, adjusted odds ratio: 3.5, 95% confidence interval: 1.60–7.74). Early AROM was not associated with an increased risk of chorioamnionitis or adverse maternal or fetal outcomes. Conclusion In this observational cohort, early AROM was associated with an increased risk of cesarean. A randomized controlled trial is necessary to determine the optimal timing of AROM in preterm patients requiring delivery.

scholarly journals The impact of school uniforms on primary school student’s physical activity at school: outcomes of a cluster randomized controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Nicole Nathan ◽  
Nicole McCarthy ◽  
Kirsty Hope ◽  
Rachel Sutherland ◽  
Christophe Lecathelinais ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Trial Registration ◽  
Sedentary Activity ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
The Impact

Abstract Background Many school-based physical activity (PA) interventions are complex and have modest effects when delivered in real world contexts. A commonly reported barrier to students’ PA, particularly among girls, are uniforms that are impractical (e.g. tunic/dress and black leather shoes). Modifying student uniforms may represent a simple intervention to enhance student PA. The primary aim of this trial was to assess the impact of a PA enabling uniform intervention (shorts, polo shirt and sports shoes) on girls’ moderate-to-vigorous physical activity (MVPA) and total PA i.e. counts per minute (cpm). Methods A cluster randomized controlled trial was undertaken in 42 primary schools in New South Wales, Australia. Schools were randomized on one school day to the intervention group, where students wore a PA enabling uniform (their sports uniform) or a control group, where students wore their usual traditional uniform. Student PA was measured using wrist-worn Actigraph GT3X and GT9X accelerometers. Linear mixed models controlling for student characteristics were used to examine the effects of the intervention.. Results Of the 3351 eligible students, 2315 (69.1%) had parental consent and 2180 of these consenting students participated (94.2%) of which 1847 (84.7%) were included in the analysis. For the primary aim the study found no significant differences between girls at schools allocated to the intervention relative to the control on change in MVPA (0.76 min, 95% CI − 0.47 to 1.99, p = 0.22) or cpm (36.99, 95% CI − 13.88 to 87.86, p = 0.15). Exploratory analysis revealed small effects for a number of findings, including significant reduction in sedentary activity (− 1.77, 95% CI − 3.40 to − 0.14, p = 0.035) among all students at schools allocated to the intervention, and non-significant improvements in girls’ light intensity PA (1.47 min, 95% CI − 0.06 to 3.00, p = 0.059) and sedentary activity (− 2.23 min; 95% CI − 4.49 to 0.02, p = 0.052). Conclusion The findings suggests that the intervention may yield small improvements in some measure of PA and require substantiation in a larger RCT with longer-term follow-up. The inclusion of additional intervention components may be required to achieve more meaningful effects. Trial registration The trial was prospectively registered with Australian New Zealand Clinical Trials Register ACTRN12617001266358 1st September 2017.

scholarly journals Effects of Live Music Therapy on Autonomic Stability in Preterm Infants: A Cluster-Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1077
Author(s):  
Dana Yakobson ◽  
Christian Gold ◽  
Bolette Daniels Beck ◽  
Cochavit Elefant ◽  
Sofia Bauer-Rusek ◽  
...  
Keyword(s):  
Music Therapy ◽  
Preterm Infants ◽  
Stress Responses ◽  
Emotional Development ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Study Groups ◽  
Outcome Variable ◽  
Secondary Outcomes ◽  
Cluster Randomized

Unbuffered stress levels may negatively influence preterm-infants’ autonomic nervous system (ANS) maturation, thus affecting neurobehavior and psycho-emotional development. Music therapy (MT) is an evidence-based treatment modality in neonatal care. When coupled with skin-to-skin care (SSC), it may reduce stress responses in both preterm infants and their parents and enhance family-centered care. Accordingly, we aimed to compare the effects of combined MT and SSC and SSC alone on ANS stabilization in preterm infants. In a single-center, cluster-randomized trial design, ten two-month time-clusters were randomized to either combined MT and SSC or SSC alone. Families of preterm infants were offered two sessions of the allocated condition in the NICU, and a three-month follow up session at home. The primary outcome variable was stabilization of the ANS, defined by change in the high frequency (HF) power of heart rate variability (HRV) during the second session. Secondary outcomes included other HRV measures, parent–infant attachment, and parental anxiety at each session. Sixty-eight families were included. MT combined with SSC improved infants’ ANS stability, as indicated by a greater increase in HF power during MT compared to SSC alone (mean difference 5.19 m2/Hz, SE = 1.27, p < 0.001) (95% confidence interval 0.87 to 2.05). Most secondary outcomes were not significantly different between the study groups. MT contributes to preterm-infants’ autonomic stability, thus laying an important foundation for neuro-behavioral and psycho-emotional development. Studies evaluating longer-term effects of MT on preterm infants’ development are warranted.

Sign in / Sign up

Export Citation Format

Share Document