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15 results for “cluster-randomised trial”
Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomised clinical trial
<p>These are pseudo-anonymised data from the VIBRA randomized trial: "Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomised clinical trial". The data dictionary explains the data available in the dataset. Between August 2018 and May 2019, 257 eligible individuals from 117 consenting villages were enrolled from two districts of Lesotho, and followed up for a maximum of 15 months. The protocol was published, doi: 10.1186/s13063-019-3510-5</p>
The impact of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria in Burkina Faso: results from a cluster-randomised trial
<p>The majority of malaria infections in endemic countries are asymptomatic and a source of onward transmission to mosquitoes. Malaria transmission and disease burden could be reduced by improving early detection and treatment of these infections with active screening approaches. In an 18-month cluster-randomized study in Sapone, Burkina Faso, households were enrolled and randomised to 1 of 3 arms: arm 1 - control; arm 2 - active weekly screening for febrile individuals and treatment if rapid diagnostic test (RDT) positive; or arm 3 – active weekly fever-screening (as arm 2) plus monthly RDT-testing regardless of symptoms. The primary outcome was parasite prevalence by qPCR in the end-of-study cross-sectional survey. Secondary outcomes included parasite and gametocyte prevalence and density in all three end-of-season cross-sectional surveys, incidence of infection, and the transmissibility of infections to mosquitoes. A total of<strong> </strong>906 individuals were enrolled during 2 phases. In Phase 1, 412 individuals were enrolled between August 9 and 17, 2018, and in Phase 2, 494 individuals were enrolled between January 10 and 31, 2019. In the end-of-study cross-sectional survey, malaria parasite prevalence by qPCR was statistically significantly lower in arm 3 (29·26% 79/270), but not in arm 2 (45·66% 121/265), when compared to arm 1 (48·72% 133/273) (RR = 0·65, 95%CI = 0·52 to 0·81, P=0·0001). Total parasite and gametocyte prevalence and density were also significantly lower in arm 3 in all surveys. The largest differences were seen at the end of the dry season, with gametocyte prevalence 78·38 % and transmission potential 98·20% lower in arm 3 vs arm 1. Active monthly RDT testing and treatment can reduce parasite carriage and the infectious reservoir of malaria to <2% when used during the dry season. This insight may inform approaches for malaria control and elimination.</p>
The impact of weekly fever-screening and treatment and monthly RDT testing and treatment on the infectious reservoir of malaria in Burkina Faso: results from a cluster-randomised trial
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Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicenter, assessor-blinded, cluster-randomised clinical trial
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Data from: The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: a pragmatic cluster-randomised controlled trial
Background: Effective and cost-effective primary care treatments for low back pain (LBP) are required to reduce the burden of the world's most disabling condition. This study aimed to compare the clinical effectiveness and cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach to LBP (intervention) with usual general practitioner (GP) care (control). Methods and findings: This pragmatic, cluster-randomised controlled trial with process evaluation and parallel economic evaluation was conducted in the Hutt Valley, New Zealand. Eight general practices were randomly assigned (stratified by practice size) with a 1:1 ratio to intervention (4 practices; 34 GPs) or control group (4 practices; 29 GPs). Adults presenting to these GPs with LBP as their primary complaint were recruited. GPs in the intervention practices were trained in the FREE approach, and patients presenting to these practices received care based on the FREE approach. The FREE approach restructures LBP consultations to prioritise early identification and management of barriers to recovery. GPs in control practices did not receive specific training for this study, and patients presenting to these practices received usual care. Between 23 September 2016 and 31 July 2017, 140 eligible patients presented to intervention practices (126 enrolled) and 110 eligible patients presented to control practices (100 enrolled). Patient mean age was 46.1 years (SD 14.4), and 46% were female. The duration of LBP was less than 6 weeks in 88% of patients. Primary outcome was change from baseline in patient participant Roland Morris Disability Questionnaire (RMDQ) score at 6 months. Secondary patient outcomes included pain, satisfaction, and psychosocial indices. GP outcomes included attitudes, knowledge, confidence, and GP LBP management behaviour. There was active and passive surveillance of potential harms. Patients and outcome assessors were blind to group assignment. Analysis followed intention-to-treat principles. A total of 122 (97%) patients from 32 GPs in the intervention group and 99 (99%) patients from 25 GPs in the control group were included in the primary outcome analysis. At 6 months, the groups did not significantly differ on the primary outcome (adjusted mean RMDQ score difference 0.57, 95% CI −0.64 to 1.78; p = 0.354) or secondary patient outcomes. The RMDQ difference met the predefined criterion to indicate noninferiority. One control group participant experienced an activity-related gluteal tear, with no other adverse events recorded. Intervention group GPs had improvements in attitudes, knowledge, and confidence compared with control group GPs. Intervention group GP LBP management behaviour became more guideline concordant than the control group. In cost-effectiveness, the intervention dominated control with lower costs and higher Quality-Adjusted Life Year (QALY) gains. Limitations of this study were that although adequately powered for primary outcome assessment, the study was not powered for evaluating some employment, healthcare use, and economic outcomes. It was also not possible for research nurses (responsible for patient recruitment) to be masked on group allocation for practices. Conclusions: Findings from this study suggest that the FREE approach improves GP concordance with LBP guideline recommendations but does not improve patient recovery outcomes compared with usual care. The FREE approach may reduce unnecessary healthcare use and produce economic benefits. Work participation or health resource use should be considered for primary outcome assessment in future trials of undifferentiated LBP.
Blueprint for modelling time effects in a stepped-wedge, cluster-randomised trial
<div><strong># Project title</strong></div> <div>Blueprint for modelling time effects in a stepped-wedge, cluster-randomised trial</div> <div> </div> <div><strong># Brief project overview</strong></div> <div>This is Data coming out of the IPOS-Dem project, a Stepped-wedge Cluster Randomised Trial (SW-CRT). Please make shure to check out the SW-CRT protocol for more details at <a href="https://www.doi.org/10.1111/jan.14953">https://www.doi.org/10.1111/jan.14953</a>. </div> <div> </div> <div>We are currently working on our main study (SW-CRT) analysis. While we remain dedicated to open science, our priority is to ensure the utmost integrity of our ongoing research.</div> <div> </div> <div><strong># Contributors</strong></div> <div>Frank Spichiger, Andrea Koppitz, André Meichtry</div> <div> </div> <div><strong>## Repository overview</strong></div> <div> </div> <div>|-- readme.md</div> <div>|-- documentation</div> <div> |--readme.md</div> <div> |--Datadictionary.html</div> <div>|-- data</div> <div> |--readme.md</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_Qualidem.feather</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_Qualidem.feather</div> <div> |--csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_Qualidem.csv</div> <div> |--IPOS-Dem_CH-SW-CRT_PLD_locf_Qualidem.csv</div> <div>|-- analysis</div> <div> |--readme.md</div> <div> |--240229_Analysis_Main.html</div> <div> |--240229_Analysis_Main.qmd</div> <div> |--grateful-refs.bib</div> <div> |--output</div> <div> |--models-REML.csv</div> <div> |--models.csv</div> <div> |--figures</div> <div> |--Conversions for plotting - 1.png</div> <div> |--Define Model 5-1.png</div> <div> |--Defining Model 4-1.png</div> <div> |--m1predictions.eps</div> <div> |--m1predictions.png</div> <div> |--m2predictions.eps</div> <div> |--m2predictions.png</div> <div> |--m3predictions.eps</div> <div> |--m3predictions.png</div> <div> |--m4predictions.eps</div> <div> |--m4predictions.png</div> <div> |--m5predictions.eps</div> <div> |--m5predictions.png</div> <div> |--Model 1 plot-1.png</div> <div> |--Model 1 plot-2.png</div> <div> |--Model 2 plot-1.png</div> <div> |--Model 2 plot-2.png</div> <div> |--Model 3 plot-1.png</div> <div> |--More plots for Model 1-1.png</div> <div> |--More plots for Model 1-2.png</div> <div> |--More plots for Model 4-1.png</div> <div> |--More plots for Model 5-1.png</div> <div> |--Plots for Model 4-1.png</div> <div> |--Plots for Model 5-1.png</div> <div> |--Plots for the other two models-1.png</div> <div> |--Plots for the other two models-2.png</div> <div> </div> <div> </div> <div># Applicable instructions</div> <div>The R markdown files were generated using R 4.2.2 in RStudio 2023.12.1 for MacOS X you can run them using free software but will need to install R, Rstudio and the packages cited at the end of the quarto or the rendered html we used.</div> <div> </div> <div># Additional resources</div> <div>- Main study protocol: <a href="https://www.doi.org/10.1111/jan.14953">https://www.doi.org/10.1111/jan.14953</a></div> <div>- QUALIDEM measure used: <a href="https://doi.org/10.1186/1477-7525-11-91">https://doi.org/10.1186/1477-7525-11-91</a> </div> <div>- Pos-Pal consortium with more information on the measure: <a href="https://www.pos-pal.org">https://www.pos-pal.org</a></div> <div>- IPOS-Dem translation and adaption: <a href="https://www.doi.org/10.1186/s41687-022-00420-7">https://www.doi.org/10.1186/s41687-022-00420-7</a></div> <div>- IPOS-Dem inter-rating reliability: <a href="https://doi.org/10.1371/journal.pone.0286557">https://doi.org/10.1371/journal.pone.0286557 </a></div>
Medication Reviews Bridging Healthcare: a Cluster-randomised Crossover Trial
ClinicalTrials.gov study NCT02999412. IPD Sharing: NO. Countries: 1. Publications: 6.
A Cluster-randomised Trial of Interventions to Improve Antimalarial Prescribing With Malaria Tests
ClinicalTrials.gov study NCT01292707. IPD Sharing: Not stated. Countries: 1. Publications: 3.
Effect of Person-Centred-Care on Antipsychotic Drug Use in Nursing Homes: a Cluster-randomised Trial
ClinicalTrials.gov study NCT02295462. IPD Sharing: Not stated. Countries: 1. Publications: 4.
Data from: The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: a pragmatic cluster-randomised controlled trial
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Data from: Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: a cluster-randomised controlled trial
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Data from: A structured training program for health workers in intravenous treatment with fluids and antibiotics in nursing homes: a modified stepped-wedge cluster-randomised trial to reduce hospital admissions
Objectives: Hospitalization is potentially detrimental to nursing home patients and resource demanding for the specialist health care. This study assessed if a brief training program in administrating intravenous fluids and antibiotics in nursing homes could reduce hospital transfers and ensure high quality care locally. Design: A pragmatic and modified cluster randomized stepped-wedge trial with randomization on nursing home level. Participants: 330 cases in 296 nursing home residents from 30 nursing homes were included. Cases were patients provided intravenous antibiotics or intravenous fluids, in nursing home or hospital. Primary outcome was localization of treatment, secondary outcomes were number of days treated, days of hospitalization among admitted patients, type of antibiotics used and 30-day mortality. Intervention: The nursing homes sequentially received a one-day educational program for the health workers including theory and practical training in intravenous treatment of dehydration and infection, run by two skilled nurses. After completing the training program, the nursing homes had competence to provide intravenous treatment locally. Results: The intervention had a highly significant effect on treatment in nursing homes (OR 8.35, 2.08 to 33.6; P<0.01, or RR 2.23, 1.48 to 2.56). The number treated in nursing homes was stable over time; the number treated in hospital gradually decreased (chi square for trend P< 0.001). Among patients receiving intravenous antibiotics in the nursing homes, 50 (46%) died within 30 days, compared to 30 (36%) treated in the hospital (P=0.19). Among patients receiving intravenous fluids locally, 21 (19%) died within 30 days, compared to 2 (8%) in the hospital group (P=0.34). Mortality was associated with reduced consciousness and elevated c-reactive protein. Conclusions: A brief educational program delivered to nursing home personnel was feasible and effective in reducing acute hospital admissions from nursing homes for treatment of dehydration and infections.
Can Doctors Reduce COVID-19 Misinformation and Increase Vaccine Uptake in Ghana? A Cluster-randomised Controlled Trial
ClinicalTrials.gov study NCT06191211. IPD Sharing: YES. Countries: 1. Publications: 0.
Data from: A structured training program for health workers in intravenous treatment with fluids and antibiotics in nursing homes: a modified stepped-wedge cluster-randomised trial to reduce hospital admissions
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Comparison of Four Different Supplementary Foods in the Treatment of Moderate Acute Malnutrition (MAM) in Children in Sierra Leone: a Cluster-randomised, Controlled Clinical Effectiveness Trial
ClinicalTrials.gov study NCT02077907. IPD Sharing: Not stated. Countries: 0. Publications: 0.
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