scholarly journals Protocol for a cluster randomised trial to evaluate a community level complementary food safety and hygiene and nutrition intervention in Mali: The MaaCiwara study

2021 ◽  
Author(s):  
Samuel I Watson ◽  
Evans A Asamane ◽  
Richard J Lilford ◽  
Karla Hemming ◽  
Cheick Sidibe ◽  
...  
Keyword(s):  
Food Safety ◽  
Structural Equation ◽  
Diarrheal Disease ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Complementary Food ◽  
Cluster Randomised Trial ◽  
Enteric Infection ◽  
Community Based ◽  
Cluster Randomised

Background Diarrheal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. This article describes a protocol for a cluster randomized trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition. Methods We will conduct a mixed-methods, parallel cluster randomised controlled trial with baseline measures. 120 clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. Participants will be mother-child dyads (27 per cluster period) with children aged 6 to 24 months. Data collection will comprise a day of observation and interviews with each participating mother-child pair and will take place at baseline and four and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutritional content of meals, and child anthropometry. A secondary structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Conclusions The trial will provide evidence on the effectiveness of community-based behavioural change and educational interventions designed to reduce the burden of diarrhoeal disease in the under fives, and how effectiveness varies across different contexts.

scholarly journals We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Catherine Hayes ◽  
Aurelia Ciblis ◽  
Catherine Darker ◽  
Nadine Dougall ◽  
Joanne Vance ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Health Service ◽  
Sample Size ◽  
Quantitative Methods ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised

Abstract Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.

scholarly journals Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016355 ◽  
Author(s):  
Fiona Elizabeth Lecky ◽  
Wanda Russell ◽  
Graham McClelland ◽  
Elspeth Pennington ◽  
Gordon Fuller ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Injury Severity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Measurable Effect ◽  
Cluster Randomised ◽  
Head Injured ◽  
Secondary Transfer

ObjectiveReconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect.SettingTwo English Ambulance Services.Participants74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC.InterventionsIntervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC.OutcomesTrial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes.Results56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%).ConclusionBypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely.Trial registration numberISRCTN68087745.

scholarly journals Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031589
Author(s):  
Christopher Bonell ◽  
Matthew Dodd ◽  
Elizabeth Allen ◽  
Leonardo Bevilacqua ◽  
Jennifer McGowan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cigarette Use ◽  
School Environments ◽  
Broader Impacts ◽  
Cluster Randomised ◽  
Disciplinary Procedures ◽  
Aggressive Behaviours ◽  
Post Hoc

BackgroundWe have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of ‘Learning Together’, an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.ObjectivesTo conduct post hoc theory-driven analyses of broader impacts.DesignCluster randomised trial.Settings40 state secondary schools in southern England.ParticipantsStudents aged 11/12 years at baseline.OutcomesStudent self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.ResultsWe found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.ConclusionThese analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.Trial registration numberISRCTN10751359.

scholarly journals Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023436 ◽  
Author(s):  
Christian Gold ◽  
Jasmin Eickholt ◽  
Jörg Assmus ◽  
Brynjulf Stige ◽  
Jo Dugstad Wake ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Controlled Trial ◽  
Elderly Care ◽  
Neuropsychiatric Symptoms ◽  
Care Home ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

IntroductionIn older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.Methods and analysisThis large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.Ethics and disseminationEthical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.Trial registration numbersNCT03496675; Pre-results, ACTRN12618000156280.

scholarly journals Effectiveness of a peer-led adolescent mental health intervention on HIV virological suppression and mental health in Zimbabwe: protocol of a cluster-randomised trial

2020 ◽  
Vol 7 ◽  
Author(s):  
Silindweyinkosi Chinoda ◽  
Abigail Mutsinze ◽  
Victoria Simms ◽  
Rhulani Beji-Chauke ◽  
Ruth Verhey ◽  
...  
Keyword(s):  
Mental Health ◽  
Common Mental Disorder ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Virological Suppression ◽  
Cluster Randomised Trial ◽  
Depression Symptoms ◽  
Cluster Randomised ◽  
Living With Hiv

Abstract Background Adolescents living with HIV (ALHIV) experience a high burden of mental health disorder which is a barrier to antiretroviral therapy adherence. In Zimbabwe, trained, mentored peer supporters living with HIV (Community Adolescent Treatment Supporters – CATS) have been found to improve adherence, viral suppression and psychosocial well-being among ALHIV. The Friendship Bench is the largest integrated mental health programme in Africa. We hypothesise that combining the CATS programme and Friendship Bench will improve mental health and virological suppression among ALHIV compared with the CATS programme alone. Methods We will conduct a cluster-randomised controlled trial in 60 clinics randomised 1:1 in five provinces. ALHIV attending the control arm clinics will receive standard CATS support and clinic support following the Ministry of Health guidelines. Those attending the intervention arm clinics will receive Friendship Bench problem-solving therapy, delivered by trained CATS. Participants with the signs of psychological distress will be referred to the clinic for further assessment and management. The primary outcome is HIV virological failure (≥1000 copies/ml) or death at 48 weeks. Secondary outcomes include the proportion of adolescents with common mental disorder symptoms (defined as Shona Symptom Questionnaire (SSQ-14) score ≥8), proportion with depression symptoms (defined as Patient Health Questionnaire (PHQ-9) score ≥11), symptom severity (mean SSQ-14 and PHQ-9 scores) and EQ-5D score for health-related quality of life. Conclusions This trial evaluates the effectiveness of peer-delivery of mental health care on mental health and HIV viral load among ALHIV. If effective this intervention has the potential to be scaled-up to improve these outcomes. Trial registration: PACTR201810756862405. 08 October 2018.

scholarly journals Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e040219
Author(s):  
Kieran S O'Brien ◽  
Valerie M Stevens ◽  
Raghunandan Byanju ◽  
Ram Prasad Kandel ◽  
Gopal Bhandari ◽  
...  
Keyword(s):  
Visual Impairment ◽  
Randomised Trial ◽  
Population Level ◽  
Age Related Macular Degeneration ◽  
Eye Disease ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised ◽  
Referral Criteria ◽  
Age Related

IntroductionThe majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level.Methods and analysisThis protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention.Ethics and disseminationThe trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings.Trial registration numberNCT03752840

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