scholarly journals Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Abdou Amza ◽  
Boubacar Kadri ◽  
Beido Nassirou ◽  
Ahmed M. Arzika ◽  
Ariana Austin ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Clinical Signs ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Baseline Assessment ◽  
Randomized Controlled ◽  
Registration Number ◽  
Cluster Randomized ◽  
Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

scholarly journals Effectiveness and implementation of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster Randomized Controlled Trial SMS reminders and tailored feedback through evriMED and adherence to TB treatment

2019 ◽  
Author(s):  
I. Marion Sumari-de Boer ◽  
Francis M Pima ◽  
Kennedy M Ngowi ◽  
Geoffrey M Chelangwa ◽  
Linda Minja ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Care Facility ◽  
Health Care Facility ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Tb Treatment ◽  
Sms Reminders ◽  
Cluster Randomized ◽  
Health Organization ◽  
Monitoring Technologies

Abstract Background: Adherence to Tuberculosis (TB) treatment is challenging because of many factors. The World Health Organization (WHO) has recommended the use of digital adherence monitoring technologies in its End-TB-strategy. However, there is paucity on its evidence in improving adherence. EvriMED is a real time medication monitoring (RTMM) device which was found feasible and acceptable in few studies in Asia. However, in Tanzania, there may be challenges in implementing evriMED due to stigmatization, network and power access, accuracy and cost effectiveness which may have an implication for treatment outcomes. We propose a pragmatic cluster randomized trial, to investigate the effectiveness of evriMED with reminder cues and tailored feedback on adherence to TB treatment in Kilimanjaro, Tanzania. Methods: We will create clusters in Kilimanjaro based on level of health care facility. Clusters will be randomized in an intervention arm, where evriMED will be implemented or a control arm, where standard practice Directly Observed Treatment (DOT) will be followed. TB patients in intervention clusters will take their medication from the evriMED pillbox and receive tailored feedback. We will use the ‘Stages­of-change’­model, which assumes that a person has to go through the stages of pre-contemplation, contemplation, preparation, action and evaluation to change behaviour for tailored feedback on adherence reports from the device. Discussion: If the intervention shows a significant effect on adherence and the devices are accepted, accurate and sustainable, the intervention can be scaled up within the National Tuberculosis Programmes. Trial registration: PACTR201811755733759 at 8 November 2018 at https://pactr.samrc.ac.za/

scholarly journals Enhancing family-based long-term care with a model of community integrated intermediary care (CIIC) service for Thai older adults in Chiang Mai, Thailand: Protocol for a cluster randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Myo Nyein Aung ◽  
Saiyud Moolphate ◽  
Motoyuki Yuasa ◽  
Thin Nyein Nyein Aung ◽  
Yuka Koyanagi ◽  
...  
Keyword(s):  
Older People ◽  
Long Term Care ◽  
Controlled Trial ◽  
World Health ◽  
Term Care ◽  
Randomized Controlled ◽  
Family Based ◽  
Cluster Randomized ◽  
Health Organization

BACKGROUND Thailand is one of the most rapidly aging countries in Asia. Traditional family-based care that has been the basis of most care for the older people is becoming unsustainable as families become smaller. In addition, women tend to be adversely affected as they still form the bulk of caregivers for older people, and many are likely to exit the labour market in order to provide care. Many family caregivers also have no or minimal training, and they may be called upon to provide quite complex care, raising the spectre of older people receiving sub-optimal care if they rely only on informal care that is provided by families and friends. Facing a rising burden of non-communicable diseases and age-related morbidity, Thai communities are increasingly in need of community integrated care model for older persons which can link existing health system and reduce the burden upon caring families. This need is common to many countries in the Association of Southeast Asian Nations (ASEAN). OBJECTIVE In this study, we aimed to assess the effectiveness of community-integrated intermediary care (CIIC) model to enhance family-based care for older people. METHODS This paper describes a cluster randomized controlled trial, comprising six intervention clusters and six control clusters that aim to recruit 2000 participants in each arm. This research protocol has been approved by the World Health Organization (WHO) Ethics Review Committee (ERC). The intervention clusters will receive an integrated model of care structured around 1) a community respite service, 2) the strengthening of family care capacity; and 3) an exercise program that aims to prevent entry into long-term care for older people. Control group clusters receive usual care i.e., the current system of long-term care common to all provinces in Thailand, consisting principally of a volunteer-assisted homecare service. The trial will be conducted in a period of two years. The primary outcome is the burden of family caregivers measured at a six month follow up, applying the caregiver burden inventory. Secondary outcomes consist of bio-psychosocial indicators including functional ability applying activity of daily living scale, depression applying geriatric depression scale and quality of life of older people applying the EuroQol 5-dimensions 5-levels scale. Intention-to-treat analysis will be followed. RESULTS n/A CONCLUSIONS Since ASEAN and many Asian countries share similar traditional family-based long-term care systems, the proposed CIIC model and the protocol for its implementation and evaluation may benefit other countries wishing to adopt similar community integrated care models for older people at risk of needing long-term care. CLINICALTRIAL World Health Organization Ethical Review Committee approval: WHO/ERC ID; ERC.0003064 Thailand Clinical Trial Registry, Trial registration number TCTR20190412004

scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Manisha A. Kulkarni ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Jimma Zone ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Ethiopia is one of the ten countries in the world that together account for almost 60% of all maternal deaths. Recent reductions in maternal mortality have been seen, yet just 26% of women who gave birth in Ethiopia in 2016 reported doing so at a health facility. Maternity waiting homes (MWHs) have been introduced to overcome geographical and financial barriers to institutional births but there is no conclusive evidence as to their effectiveness. We aim to evaluate the effects of upgraded MWHs and local leader training in increasing institutional births in the Jimma zone of Ethiopia. Methods A parallel, three-arm, stratified, cluster-randomized controlled trial design is being employed to evaluate intervention effects on institutional births, which is the primary outcome. Trial arms are: (1) upgraded MWH + religious/community leader training; (2) leader training alone; and (3) standard care. Twenty-four primary health care unit catchment areas (clusters) have been randomized and 3840 women of reproductive age who had a pregnancy outcome (livebirth, stillbirth or abortion) are being randomly recruited for each survey round. Outcome assessments will be made using repeat cross-sectional surveys at baseline and 24 months postintervention. An intention to treat approach will be used and the primary outcome analysed using generalized linear mixed models with a random effect for cluster and time. A cost-effectiveness analysis will also be conducted from a societal perspective. Discussion This is one of the first trials to evaluate the effectiveness of upgraded MWHs and will provide much needed evidence to policy makers about aspects of functionality and the community engagement required as they scale-up this programme in Ethiopia. Trial registration ClinicalTrial.gov, NCT03299491. Retrospectively registered on 3 October 2017.

Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist

2020 ◽  
Vol 41 (11) ◽  
pp. 1266-1271
Author(s):  
Trevor C. Van Schooneveld ◽  
Mark E. Rupp ◽  
R. Jenifer Cavaleiri ◽  
Elizabeth Lyden ◽  
Kiri Rolek
Keyword(s):  
Controlled Trial ◽  
Early Period ◽  
Cluster Randomized Trial ◽  
Antibiotic Use ◽  
Effective Strategies ◽  
Randomized Controlled ◽  
Time Out ◽  
Academic Medical ◽  
Cluster Randomized ◽  
Medicine Team

AbstractObjective:Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.Design:Cluster randomized controlled trial.Setting:Six medicine teams at an academic medical facility.Patients:Inpatients who received antibiotics and were cared for by a medicine team.Intervention:In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).Results:In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.Conclusions:Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.

scholarly journals Effects of Self-Care for Older PErsons (SCOPE) on Functional and Physiological Measures: A Cluster Randomized Controlled Trial

2020 ◽  
Vol 9 (3) ◽  
pp. 885
Author(s):  
Ted Kheng Siang Ng ◽  
David Bruce Matchar ◽  
Rehena Sultana ◽  
Angelique Chan
Keyword(s):  
Older Adults ◽  
Older Persons ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Self Care ◽  
Community Dwelling ◽  
Physiological Measures ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Community Dwelling Older Adults

Background: Population aging poses unprecedented demands on the healthcare system. There is also a scarcity of evidence on self-care intervention to improve objective measures of morbidity and aging-associated functional and physiological measures in a low-income multi-ethnic population setting. Methods: We conducted a cluster randomized controlled trial (ClinicalTrials.gov Identifier: NCT01672177) to examine the effects of the Self-Care for Older PErsons (SCOPE) program. We randomized 14 Senior Activity Centers and randomly selected older adults within these centers. Functional and physiological measurements were performed at baseline, 10-month, and 18-month periods. The primary outcome was a composite of three morbidity-specific measures, which include hemoglobin A1c (HbA1C), peak expiratory flow, and systolic blood pressure. Aging-associated functional and physiological measures were examined as secondary outcomes. Repeated-measure mixed models were employed to examine the effects of SCOPE on these measures. Results: 378 community-dwelling older adults participated in either the treatment (n= 164) or the control arm (n = 214). The primary outcome was not significantly improved. For the secondary outcomes, SCOPE participants demonstrated slower oxygen desaturation at an 18-month period (p = 0.001), improved time to complete the chair-stand test (p < 0.001) at a 10-month period with the effect persisting at the 18-month period (p < 0.001). SCOPE participants also had significantly improved vitamin B12 levels at the 18-month period (p < 0.001), increased hemoglobin concentration (p < 0.001), decreased mean corpuscular volume (p = 0.001), and decreased creatinine (p = 0.002) at the 10-month period. Conclusions: SCOPE did not improve morbidity-specific measures. However, it improved several aging-associated measures implicated in geriatric syndromes. This study highlights the potential of a self-care program in the prevention of geriatric syndromes in community-dwelling older adults, while emphasizing self-management to manage existing morbidities.

scholarly journals INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lili Song ◽  
Xin Hu ◽  
Lu Ma ◽  
Xiaoying Chen ◽  
Menglu Ouyang ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Blood Pressure Reduction ◽  
Care Bundle ◽  
Pressure Reduction ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH. Methods INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (α = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions. Discussion As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established. Trial registration ClinicalTrials.gov NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017

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 Insecticide resistance characteristic of Anopheles vector species successfully controlled by deployment of pyrethroid and PBO long lasting insecticidal treated nets (LLINs) in Tanzania

2021 ◽  
Author(s):  
Johnson Matowo ◽  
David Weetman ◽  
Patricia Pignatell ◽  
Alexandra Wright ◽  
Jacques Charlwood ◽  
...  
Keyword(s):  
Insecticide Resistance ◽  
Pyrethroid Resistance ◽  
Cluster Randomized Trial ◽  
World Health ◽  
Malaria Vectors ◽  
Metabolizing Enzymes ◽  
Sub Saharan ◽  
Underlying Mechanisms ◽  
Cluster Randomized ◽  
Health Organization

Long lasting insecticidal nets (LLINs) are a proven tool to reduce malaria transmission, but in Africa efficacy is being reduced by pyrethroid resistance in the major vectors. A cluster randomized trial in Muleba district, Tanzania demonstrated that permethrin LLINs co-treated with piperonyl butoxide (PBO), a synergist that can block pyrethroid-metabolizing enzymes in the mosquito, had much greater efficacy than pyrethroid-only nets. Insecticide resistance profiles and underlying mechanisms were investigated in Anopheles gambiae and An. funestus from Muleba during the trial. Diagnostic dose bioassays using permethrin, together with intensity assays, suggest pyrethroid resistance that is both strong and very common, but not extreme. Transcriptomic analysis found multiple P450 genes over expressed including CYP6M2, CYP6Z3, CYP6P3, CYP6P4, CYP6AA1 and CYP9K1 in An. gambiae and CYP6N1, CYP6M7, CYP6M1 and CYP6Z3 in An. funestus. Indeed, very similar suites of P450 enzymes commonly associated with resistant populations elsewhere in Africa were detected as over expressed suggesting a convergence of mechanisms across Sub-Saharan African malaria vectors. The findings give insight into factors that may correlate with pyrethroid PBO LLIN success, broadly supporting model predictions, but revision to guidelines previously issued by the World Health Organization is warranted.

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