scholarly journals Rojiroti microfinance and child nutrition: a cluster randomised trial

2019 ◽  
Vol 105 (3) ◽  
pp. 229-235 ◽  
Author(s):  
Shalini Ojha ◽  
Lisa Szatkowski ◽  
Ranjeet Sinha ◽  
Gil Yaron ◽  
Andrew Fogarty ◽  
...  
Keyword(s):  
Child Nutrition ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Z Score ◽  
Primary Analysis ◽  
Height Measurement ◽  
Cluster Randomised ◽  
Children Under 5

ObjectiveTo determine whether Rojiroti microfinance, for poor Indian women, improves child nutrition.DesignCluster randomised trial.SettingTolas (village communities) in Bihar State.ParticipantsWomen and children under 5 years.InterventionsWith Rojiroti microfinance, women form self-help groups and save their money to provide loans to group members. After 6 months, they receive larger external loans. Tolas were randomised to receive Rojiroti immediately or after 18 months.Outcome measuresThe primary analysis compared the mean weight for height Z score (WHZ) of children under 5 years in the intervention versus control tolas who attended for weight and height measurement 18 months after randomisation. Secondary outcomes were weight for age Z score (WAZ), height for age Z score, mid-upper arm circumference (MUAC), wasting, underweight and stunting.ResultsWe randomised 28 tolas to each arm and collected data from 2469 children (1560 mothers) at baseline and 2064 children (1326 mothers) at follow-up. WHZ was calculated for 1718 children at baseline and 1377 (674 intervention and 703 control) at follow-up. At 18 months, mean WHZ was significantly higher for intervention (−1.02) versus controls (−1.37; regression coefficient adjusted for clustering β=0.38, 95% CI 0.16 to 0.61, p=0.001). Significantly fewer children were wasted in the intervention group (122, 18%) versus control (200, 29%; OR=0.46, 95% CI 0.28 to 0.74, p=0.002). Mean WAZ was better in the intervention group (−2.13 vs −2.37; β=0.27, 95% CI 0.11 to 0.43, p=0.001) as was MUAC (13.6 cm vs 13.4 cm; β=0.22, 95% CI 0.03 to 0.40, p=0.02). In an analysis adjusting for baseline nutritional measures (259 intervention children and 300 control), only WAZ and % underweight showed significant differences in favour of the intervention.ConclusionIn marginalised communities in rural India, child nutrition was better in those who received Rojiroti microfinance, compared with controls.Trial registration numberNCT01845545.

Analysis of self-efficacy for stroke recognition and action from a cluster randomised trial evaluating the effects of stroke education pamphlets versus a 12-minute culturally tailored stroke film among Black and Hispanic churchgoers in New York

2021 ◽  
pp. 001789692110028
Author(s):  
Daudet Ilunga Tshiswaka ◽  
Jeanne Teresi ◽  
Joseph P. Eimicke ◽  
Jian Kong ◽  
James M. Noble ◽  
...  
Keyword(s):  
New York ◽  
Usual Care ◽  
Self Efficacy ◽  
Retention Rate ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact

Background: Because early recognition of symptoms and timely treatment of stroke can reduce mortality and the long-term effects of such events, efforts to make many people both aware of these symptoms and knowledgeable about what to do when recognising them are critical for reducing impacts from stroke. Objectives: To assess the impact of a stroke preparedness film (intervention) and stroke preparedness pamphlets (usual care) on self-efficacy for stroke recognition and action. Design: Two-arm cluster randomised trial conducted between July 2013 and August 2018. Setting: A total of 13 church sites located in economically disadvantaged urban neighbourhoods in New York. Of the 883 churchgoers approached, 503 expressed interest, 375 completed eligibility screening and 312 were randomised. Participant inclusion criteria were Black or Hispanic churchgoers, aged 34 years or older, without stroke history, but at a high risk for stroke. The intervention consisted of two 12-minute stroke films: Gospel of Stroke, in English for Black participants, and Derrame Cerebral, in Spanish for Hispanic participants. Method: Participants were pre–post-tested (at baseline, 6-month follow-up and 12-month follow-up) for self-efficacy. Descriptive analysis, a linear mixed model and t tests were used to assess the effects of a stroke preparedness film and stroke preparedness pamphlets on self-efficacy. Results: Findings are based on intention-to-treat analysis. A total of 310 participants completed the study (99% retention rate). About half (53.8%) of participants were Black and 46.2% Hispanic in the intervention group; 48.3% were Black and 51.7% were Hispanic in the usual care group. Overall, both groups evidenced higher self-efficacy (i.e. lower predicted means) over time ( p < .0001), although a significant benefit was not observed for the intervention relative to usual care. Conclusion: Both stroke preparedness films and stroke preparedness pamphlets improved self-efficacy with respect to stroke recognition and action among minority churchgoers.

scholarly journals Secular trend, seasonality and effects of a community-based intervention on neonatal mortality: follow-up of a cluster-randomised trial in Quang Ninh province, Vietnam

2018 ◽  
Vol 72 (9) ◽  
pp. 776-782
Author(s):  
Leif Eriksson ◽  
Nguyen T Nga ◽  
Dinh T Phuong Hoa ◽  
Duong M Duc ◽  
Anna Bergström ◽  
...  
Keyword(s):  
Time Series ◽  
Neonatal Mortality ◽  
Secular Trend ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Neonatal Deaths ◽  
Live Births ◽  
Cluster Randomised ◽  
Quang Ninh

BackgroundLittle is know about whether the effects of community engagement interventions for child survival in low-income and middle-income settings are sustained. Seasonal variation and secular trend may blur the data. Neonatal mortality was reduced in a cluster-randomised trial in Vietnam where laywomen facilitated groups composed of local stakeholders employing a problem-solving approach for 3 years. In this analysis, we aim at disentangling the secular trend, the seasonal variation and the effect of the intervention on neonatal mortality during and after the trial.MethodsIn Quang Ninh province, 44 communes were allocated to intervention and 46 to control. Births and neonatal deaths were assessed in a baseline survey in 2005, monitored during the trial in 2008–2011 and followed up by a survey in 2014. Time series analyses were performed on monthly neonatal mortality data.ResultsThere were 30 187 live births and 480 neonatal deaths. The intervention reduced the neonatal mortality from 19.1 to 11.6 per 1000 live births. The reduction was sustained 3 years after the trial. The control areas reached a similar level at the time of follow-up. Time series decomposition analysis revealed a downward trend in the intervention areas during the trial that was not found in the control areas. Neonatal mortality peaked in the hot and wet summers.ConclusionsA community engagement intervention resulted in a lower neonatal mortality rate that was sustained but not further reduced after the end of the trial. When decomposing time series of neonatal mortality, a clear downward trend was demonstrated in intervention but not in control areas.Trial registration numberISRCTN44599712, Post-results.

Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial

2017 ◽  
Vol 27 (5) ◽  
pp. 355-364 ◽  
Author(s):  
Jeffrey Todd Kullgren ◽  
Erin Krupka ◽  
Abigail Schachter ◽  
Ariel Linden ◽  
Jacquelyn Miller ◽  
...  
Keyword(s):  
Primary Care ◽  
Low Back Pain ◽  
Randomised Trial ◽  
Choosing Wisely ◽  
Cluster Randomised Trial ◽  
Low Back ◽  
Stepped Wedge ◽  
Intervention Period ◽  
Cluster Randomised

BackgroundLittle is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders.MethodsWe conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1–6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders.ResultsThe intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up.ConclusionClinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and may have increased alternate orders.Trial registration numberNCT02247050; Pre-results.

scholarly journals Effectiveness of delivering integrated COPD care at public healthcare facilities: a cluster randomised trial in Pakistan

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101634
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Muhammad Ahmar Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Public Health ◽  
Primary Outcome ◽  
Clinical Care ◽  
Randomised Trial ◽  
Health Facilities ◽  
Cluster Randomised Trial ◽  
Public Healthcare ◽  
Public Health Facilities ◽  
Cluster Randomised

BackgroundIn Pakistan chronic obstructive pulmonary disease (COPD) prevalence is 2.1% in adults aged >40 years. Despite being a health policy focus, integrated COPD care has remained neglected, with wide variation in practice.AimTo assess whether enhanced care at public health facilities resulted in better control of COPD, treatment adherence, and smoking cessation.Design & settingA two-arm cluster randomised controlled trial was undertaken in 30 public health facilities (23 primary and 7 secondary), across three districts of Punjab, between October 2014–December 2016. Both arms had enhanced diagnosis and patient recording processes. Intervention facilities also had clinical care guides; drugs for COPD; patient education flipcharts; associated staff training; and mobile phone follow-up.MethodFacilities were randomised in a 1:1 ratio (sealed envelope independent lottery method), and 159 intervention and 154 control patients were recruited. The eligibility criteria were as follows: diagnosed with COPD, aged ≥18 years, and living in the catchment area. The primary outcome was change in BODE (Body mass index, airway Obstruction, Dyspnoea, Exercise capacity) index score from baseline to final follow-up visit. Staff and patients were not blinded.ResultsSix-month primary outcomes were available for 147/159 (92.5%) intervention and 141/154 (91.6%) control participants (all clusters). The primary outcome results cluster-level analysis were as follows: mean intervention outcome = -1.67 (95% confidence intervals [CI] = -2.18 to -1.16); mean control outcome = -0.66 (95% CI = -1.09 to -0.22); and covariate-adjusted mean intervention–control difference = -0.96 (95% CI = -1.49 to -0.44; P = 0.001).ConclusionThe findings of this trial and a separate process evaluation study support the scaling of this integrated COPD care package at primary and secondary level public health facilities in Pakistan and similar settings.

scholarly journals Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e036416
Author(s):  
Laura Green ◽  
Jahnavi Daru ◽  
Julie Dodds ◽  
Francisco Jose Gonzalez Carreras ◽  
Doris Lanz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Postpartum Haemorrhage ◽  
Randomised Trial ◽  
Intervention Group ◽  
Qualitative Evaluation ◽  
Primary Objective ◽  
Cluster Randomised Trial ◽  
Control Group ◽  
Advisory Group ◽  
Cluster Randomised

IntroductionThe incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.MethodsACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.Ethics and disseminationThe trial has approvals from the London—Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.Trial registration numberISRCTN12146519.

scholarly journals Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Samantha Keogh ◽  
Caroline Shelverton ◽  
Julie Flynn ◽  
Gabor Mihala ◽  
Saira Mathew ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Control Period ◽  
Randomised Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

scholarly journals Study protocol of the BLANKET trial: a cluster randomised controlled trial on the (cost-) effectiveness of a primary care intervention for fear of cancer recurrence in cancer survivors

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032616 ◽  
Author(s):  
Yvonne L Luigjes-Huizer ◽  
Marije L van der Lee ◽  
Niek J de Wit ◽  
Charles W Helsper
Keyword(s):  
Primary Care ◽  
The Netherlands ◽  
Medical Research ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cancer Recurrence ◽  
Fear Of Cancer Recurrence ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Fear Of Cancer

IntroductionMany successfully treated patients with cancer suffer from fear of cancer recurrence (FCR), affecting their quality of life and their physical, emotional, cognitive and social functioning. Effective psychological interventions for FCR exist but are not widely available, as they are typically offered by specialised psycho-oncology professionals and institutes. Concurrently, the role of primary care in cancer and survivorship care is increasing. Therefore, there could be a role for general practitioners (GPs) and mental health workers (MHWs) working in primary care in supporting patients with FCR. In the current study, the effectiveness of a primary care delivered FCR intervention will be evaluated.Methods and analysisA two-armed cluster randomised trial will be conducted. The primary outcome will be FCR severity; secondary outcomes will be FCR-related distress, healthcare uptake and healthcare costs. Primary care practices in the Netherlands will be invited to participate in the study. Participating practices will be stratified by size and socioeconomic status and randomised. In the control arm, practices will provide care as usual. In the intervention arm, practices will offer the cognitive–behavioural FCR intervention that is being studied, which consists of an intake with the GP and five sessions with the MHW. Patients who have finished successful curative treatment for cancer between 3 months and 10 years ago will be invited to participate in the study by invitation letter from their GPs. Participating patients will fill out questionnaires at baseline, after 3 months and after 12 months. Data on healthcare use will be collected from their electronic health records. Qualitative interviews are held at T1 with patients and practitioners in the intervention group.Ethics and disseminationThe Medical Research Ethics Committee (METC) Utrecht has reviewed the study in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO) and other applicable Dutch and European regulations. Based on the requirements of the WMO, the METC Utrecht has issued an approval of the above-mentioned study. Any protocol amendments will be communicated to all relevant parties. Written consent is obtained from study participants. Results will be dispersed through peer-reviewed publications and scientific presentations.Trial registration numberNL7573 in the Netherlands Trial Register on 25-02-2019.

scholarly journals An educational intervention to prevent overweight in pre-school years: a cluster randomised trial with a focus on disadvantaged families

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Alison Hodgkinson ◽  
Janice Abbott ◽  
Margaret A. Hurley ◽  
Nicola Lowe ◽  
Pamela Qualter
Keyword(s):  
Physical Activity ◽  
Healthy Eating ◽  
School Children ◽  
Randomised Trial ◽  
Early Years ◽  
Cluster Randomised Trial ◽  
Educational Resource ◽  
Z Score ◽  
Cluster Randomised ◽  
Cluster Level

Abstract Background Early prevention is a promising strategy for reducing obesity in childhood, and Early Years settings are ideal venues for interventions. This work evaluated an educational intervention with the primary aim of preventing overweight and obesity in pre-school children. Methods A pragmatic, cluster randomised trial with a parallel, matched-pair design was undertaken. Interventions were targeted at both the cluster (Early Years’ Centres, matched by geographical area) and individual participant level (families: mother and 2-year old child). At the cluster level, a staff training intervention used the educational resource Be Active, Eat Healthy. Policies and provision for healthy eating and physical activity were evaluated at baseline and 12-months. The intervention at participant level was the Healthy Heroes Activity Pack: delivered over 6 months by Centre staff to promote healthy eating and physical activity in a fun, interactive way. Child and parent height and weight were measured at four time-points over 2 years. The trial primary outcome was the change in BMI z-score of the child between ages 2 and 4 years. Secondary outcomes consisted of parent-reported measures administered at baseline and two-year follow-up. Results Five pairs of Early Years’ Centres were recruited. Four pairs were analysed as one Centre withdrew (47 intervention families; 34 control families). At the cluster level, improvement in Centre policies and practices was similar for both groups (p = 0.830). At the participant level, the intervention group reduced their mean BMI z-score between age 2 and 4 years (p = 0.002; change difference 0.49; 95% CI 0.17 to 0.80) whereas the control group showed increasing BMI z-score throughout. Changes in parent-reported outcomes and parent BMI (p = 0.582) were similar in both groups. Conclusions The Healthy Heroes educational resource deterred excess weight gain in pre-school children from poor socioeconomic areas. With training, Early Years’ staff can implement the Healthy Heroes programme. Trial registration ISRCTN22620137 Registered 21st December 2016.

scholarly journals Effect of transporting an evidence-based, violence prevention intervention to Jamaican preschools on teacher and class-wide child behaviour: a cluster randomised trial

2018 ◽  
Vol 5 ◽  
Author(s):  
H. Baker-Henningham ◽  
S. Walker
Keyword(s):  
High Risk ◽  
Randomised Trial ◽  
Training Programme ◽  
Child Behaviour ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Observer Ratings ◽  
Two Measures ◽  
High Risk Children

Introduction.Based on extensive piloting work, we adapted the Incredible Years (IY) teacher-training programme to the Jamaican preschool setting and evaluated this adapted version through a cluster-randomised trial.Methods.Twenty-four community preschools in Kingston, Jamaica were randomly assigned to intervention (12 schools, 37 teachers) or control (12 schools, 36 teachers). The intervention involved training teachers in classroom management through eight full-day training workshops and four individual 1-h in-class support sessions. Outcome measurements included direct observation of teachers’ positive and negative behaviours to the whole class and to high-risk children and four observer ratings: two measures of class-wide child behaviour and two measures of classroom atmosphere. Measures were repeated at a six-month follow-up.Results.Significant benefits of intervention were found for teachers’ positive [effect size (ES) = 3.35] and negative (ES = 1.29) behaviours to the whole class and to high-risk children (positive: ES = 0.83; negative: ES = 0.50) and for observer ratings of class-wide child behaviour (ES = 0.73), child interest and enthusiasm (ES = 0.98), teacher warmth (ES = 2.03) and opportunities provided to share and help (ES = 5.72). At 6-month follow-up, significant benefits of intervention were sustained: positive behaviours (ES = 2.70), negative behaviours (ES = 0.98), child behaviour (ES = 0.50), child interest and enthusiasm (ES = 0.78), teacher warmth (ES = 0.91), opportunities to share and help (ES = 1.42).Conclusions.The adapted IY teacher-training programme produced large benefits to teacher's behaviour and to class-wide measures of children's behaviour, which were sustained at 6-month follow-up. Benefits were of a similar magnitude to those found in a pilot study of the minimally adapted version that required significantly more in-class support for teachers.

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