Randomized Controlled Trial Evaluating Hypothermia for Neonatal Encephalopathy in Low- and Middle-Income Countries

2021 ◽  
Vol 58 (10) ◽  
pp. 978-986
Author(s):  
Joseph L. Mathew ◽  
P. N. Suman Rao ◽  
K. P. Vinayan
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Neonatal Encephalopathy ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
Low And Middle Income

scholarly journals Involvement of low- and middle-income countries in randomized controlled trial publications in oncology

2014 ◽  
Vol 10 (1) ◽  
Author(s):  
Janice C Wong ◽  
Kimberly A Fernandes ◽  
Shubarna Amin ◽  
Zarnie Lwin ◽  
Monika K Krzyzanowska
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
Low And Middle Income

scholarly journals mHealth Messaging to Motivate Quitline Use and Quitting: Protocol for a Community-Based Randomized Controlled Trial in Rural Vietnam (Preprint)

2021 ◽  
Author(s):  
Celine Larkin ◽  
Jessica Wijesundara ◽  
Hoa L Nguyen ◽  
Duc Anh Ha ◽  
Anh Vuong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Text Messaging ◽  
Health Workers ◽  
Controlled Trial ◽  
Text Messages ◽  
Community Based ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled

BACKGROUND Tobacco kills more than 8 million people each year, mostly in low- and middle-income countries. In Vietnam, 1 in every 2 male adults smokes tobacco. Vietnam has set up telephone Quitline counseling that is available to all smokers, but it is underused. We previously developed an automated and effective motivational text messaging system to support smoking cessation among US smokers. OBJECTIVE The aim of this study is to adapt the aforementioned system for rural Vietnamese smokers to promote cessation of tobacco use, both directly and by increasing the use of telephone Quitline counseling services and nicotine replacement therapy. Moreover, we seek to enhance research and health service capacity in Vietnam. METHODS We are testing the effectiveness of our culturally adapted motivational text messaging system by using a community-based randomized controlled trial design (N=600). Participants were randomly allocated to the intervention (regular motivational and assessment text messages) or control condition (assessment text messages only) for a period of 6 months. Trial recruitment took place in four communes in the Hung Yen province in the Red River Delta region of Vietnam. Recruitment events were advertised to the local community, facilitated by community health workers, and occurred in the commune health center. We are assessing the impact of the texting system on 6-month self-reported and biochemically verified smoking cessation, as well as smoking self-efficacy, uptake of the Quitline, and use of nicotine replacement therapy. In addition to conducting the trial, the research team also provided ongoing training and consultation with the Quitline during the study period. RESULTS Site preparation, staff training, intervention adaptation, participant recruitment, and baseline data collection were completed. The study was funded in August 2017; it was reviewed and approved by the University of Massachusetts Medical School Institutional Review Board in 2017. Recruitment began in November 2018. A total of 750 participants were recruited from four communes, and 700 (93.3%) participants completed follow-up by March 2021. An analysis of the trial results is in progress; results are expected to be published in late 2022. CONCLUSIONS This study examines the effectiveness of mobile health interventions for smoking in rural areas in low- and middle-income countries, which can be implemented nationwide if proven effective. In addition, it also facilitates significant collaboration and capacity building among a variety of international partners, including researchers, policy makers, Quitline counselors, and community health workers. CLINICALTRIAL ClinicalTrials.gov NCT03567993; https://clinicaltrials.gov/ct2/show/NCT03567993. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30947

scholarly journals Effectiveness and moderators of a multicomponent school-based intervention on screen time devices: the Movimente cluster-randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Priscila Cristina dos Santos ◽  
Jo Salmon ◽  
Lauren Arundell ◽  
Marcus Vinicius Veber Lopes ◽  
Kelly Samara Silva
Keyword(s):  
Randomized Controlled Trial ◽  
Screen Time ◽  
Controlled Trial ◽  
Middle Income ◽  
School Based Intervention ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
School Based ◽  
8Th Grade ◽  
Cluster Randomized

Abstract Background Interventions targeting reduce screen time in adolescents are urgently needed, mainly in low and middle-income countries because of the lack of evidence. Thus, the aims of the study were to examine the effect of a cluster-randomized controlled trial on screen time (ST) devices among Brazilian adolescents and to identify possible moderators. Methods Movimente was a multicomponent school-based intervention that was performed in 2017 and consisted of teacher training, education curriculum, and environmental improvements. Baseline and post-intervention assessments (over one academic year) were conducted with students aged 10–16 years at baseline (baseline n = 921, [n = 538 intervention group; n = 383 control group]). A self-report questionnaire was used to measure daily minutes of device specific screen time (TV, computer, video games and smartphone) and demographic variables. Linear mixed models were used to examine intervention effects and an exploratory moderation analysis (sex, grade and socioeconomic status) was performed. Results The intervention had no significant effects on TV time (β = − 6.4, 95% CI: − 6.1;13.4), game time (β = − 8.2, 95% CI: − 7.2;10.8), computer time (β = 1.1, 95% CI: − 6.3;18.5), smartphone time (β = − 10.2, 95% CI: − 32.5;12.1), screen time (β = − 12.8, 95% CI: − 50.5;24.8), meeting screen time guidelines (OR: 1.29, 95% CI: 0.65,2.57) and meeting screen time guidelines with smartphone (OR: 1.66, 95% CI: 0.37,7.40). There was a significant intervention effect on reducing TV time (β = − 37.1, 95% CI: − 73.0, − 1.3) among 8th grade students only. Conclusions The Movimente intervention was effective only for TV time among 8th grade students. Understanding how school-based interventions can improve adolescents’ device specific screen time across age groups is needed. Future strategies should cover all screen-based devices. Further, there is a need for more studies in low- and-middle income countries to assist in the development of effective strategies. Trial registration Clinicaltrials.gov identifier NCT02944318 (25/10/2016).

scholarly journals Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Olawale Salami ◽  
Philip Horgan ◽  
Catrin E. Moore ◽  
Abhishek Giri ◽  
Asadu Sserwanga ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Diagnostic Tests ◽  
Antibiotic Prescription ◽  
Rapid Diagnostic Tests ◽  
Intervention Package ◽  
Middle Income ◽  
Middle Income Countries ◽  
Randomized Controlled ◽  
And Training ◽  
Low And Middle Income

Abstract Background The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the ‘just-in-case’ use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)? Methods We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion. Discussion This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs. Trial registration Clinicaltrials.gov NCT04081051. Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019

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