scholarly journals Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial

2020 ◽  
Vol 75 (11) ◽  
pp. 3373-3378 ◽  
Author(s):  
Hamideh Abbaspour Kasgari ◽  
Siavash Moradi ◽  
Amir Mohammad Shabani ◽  
Farhang Babamahmoodi ◽  
Ali Reza Davoudi Badabi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Standard Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Control Group ◽  
Single Centre ◽  
Mazandaran Province ◽  
Randomized Controlled

Abstract Background New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19. Methods This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1. Results Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray’s P = 0.033). Conclusions This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Assessing the Efficacy of an Educational Smartphone or Tablet App With Subdivided and Interactive Content to Increase Patients’ Medical Knowledge: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Thomas Timmers ◽  
Loes Janssen ◽  
Yvette Pronk ◽  
Babette C van der Zwaard ◽  
Sander Koëter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Treatment Options ◽  
Intervention Group ◽  
Control Group ◽  
Perceived Knowledge ◽  
Actual Knowledge ◽  
Positive Effects ◽  
Randomized Controlled

BACKGROUND Modern health care focuses on shared decision making (SDM) because of its positive effects on patient satisfaction, therapy compliance, and outcomes. Patients’ knowledge about their illness and available treatment options, gained through medical education, is one of the key drivers for SDM. Current patient education relies heavily on medical consultation and is known to be ineffective. OBJECTIVE This study aimed to determine whether providing patients with information in a subdivided, categorized, and interactive manner via an educational app for smartphone or tablet might increase the knowledge of their illness. METHODS A surgeon-blinded randomized controlled trial was conducted with 213 patients who were referred to 1 of the 6 Dutch hospitals by their general practitioner owing to knee complaints that were indicative of knee osteoarthritis. An interactive app that, in addition to standard care, actively sends informative and pertinent content to patients about their illness on a daily basis by means of push notifications in the week before their consultation. The primary outcome was the level of perceived and actual knowledge that patients had about their knee complaints and the relevant treatment options after the intervention. RESULTS In total, 122 patients were enrolled in the control group and 91 in the intervention group. After the intervention, the level of actual knowledge (measured on a 0-36 scale) was 52% higher in the app group (26.4 vs 17.4, P<.001). Moreover, within the app group, the level of perceived knowledge (measured on a 0-25 scale) increased by 22% during the week within the app group (from 13.5 to 16.5, P<.001), compared with no gain in the control group. CONCLUSIONS Actively offering patients information in a subdivided (per day), categorized (per theme), and interactive (video and quiz questions) manner significantly increases the level of perceived knowledge and demonstrates a higher level of actual knowledge, compared with standard care educational practices. CLINICALTRIAL International Standard Randomized Controlled Trial Number ISRCTN98629372; http://www.isrctn.com/ISRCTN98629372 (Archived by WebCite at http://www.webcitation.org/73F5trZbb)

scholarly journals Methylprednisolone or Dexamethasone, Which One Is the Superior Corticosteroid in the Treatment of Hospitalized COVID-19 Patients: A Triple-Blinded Randomized Controlled Trial

2021 ◽  
Author(s):  
Keivan Ranjbar ◽  
Reza Shahriarirad ◽  
Amirhossein Erfani ◽  
Zohre Khodamoradi ◽  
Mohammad Hasan Gholampoor Saadi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
And Control

Abstract BackgroundAlthough almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, unsolved issues remained to choose appropriate corticosteroids treatment for COVID-19. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients.MethodIn this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. Patients were randomly allocated into two groups to receive either methylprednisolone (2mg/kg/day) or dexamethasone (6mg/kg/day). Data was assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8).ResultsThere was no significant variation among the groups on the admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, P = 0.002) and day 10 (2.90 vs. 4.71, P = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group, and the control group, (3.909 vs. 4.873 respectively, P = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (P = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% P = 0.040).ConclusionIn the context of treating hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone.Trial Registration:The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals A web-based dietary intervention in early pregnancy and neonatal outcomes: a randomized controlled trial

2018 ◽  
Vol 41 (2) ◽  
pp. 371-378 ◽  
Author(s):  
R A K Kennedy ◽  
C M E Reynolds ◽  
S Cawley ◽  
E O’Malley ◽  
D M McCartney ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Intervention Group ◽  
Neonatal Outcomes ◽  
Dietary Behaviour ◽  
Control Group ◽  
Evidence Based ◽  
Randomized Controlled

Abstract Background Maternal nutrition is a determinant of pregnancy outcomes. Few studies have evaluated the potential of online nutrition resources to modify behaviour. This randomized controlled trial aimed to determine whether access to a customized evidence-based nutrition website in pregnancy improved neonatal outcomes. Methods Women <18 weeks gestation were recruited at their convenience. The control group received standard care. In addition to standard care, the intervention group received access to an evidence-based nutrition website, customized to the preferences of pregnant women. Results Of the 250 women, there were no differences in characteristics between the two groups. Of the women, 91.0% reported they make a conscious effort currently to eat a healthy diet. However, only 19.6% met dietary requirements for calcium, 13.2% for iron, 2.7% for folate and 2.3% for iodine. The most popular website section was pregnancy nutrition advice but engagement was not sustained. Access to the website was not associated with any improvement in clinical outcomes (P > 0.05). Conclusions We found that provision of a customized website providing nutrition information, did not improve neonatal outcomes. Future studies should explore whether redesign with website interactivity or embedding information on popular digital platforms sustains women’s engagement and modifies dietary behaviour.

scholarly journals Effectiveness of Kangaroo Mother Care in Intubated Preterm Neonates 28 to 36 Weeks Gestational Age, Weighing 600 to 2000 Grams at Birth: A Randomized Controlled Trial

2021 ◽  
Vol 55 (9) ◽  
Author(s):  
Shary May M. Baton ◽  
Maria Esterlita T. Villanueva-Uy ◽  
Socorro De Leon-Mendoza
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Stay ◽  
Late Onset ◽  
Controlled Trial ◽  
Intervention Group ◽  
Kangaroo Mother Care ◽  
Preterm Neonates ◽  
Control Group ◽  
Low Birth Weight Infants ◽  
Randomized Controlled

Background. Kangaroo Mother Care (KMC) is the standard of care for stable low birth weight infants. Provision of KMC to intubated preterm infants may also be beneficial, but strong evidence is still lacking. Objective. To determine the effectiveness of KMC in decreasing mortality among intubated preterm neonates. Study Design. This is a non-blinded, parallel, non-inferiority randomized controlled trial. Methodology. All intubated, preterm admissions, 28-36 weeks gestation, weighing 600-2000 grams, with respiratory distress were included. They were randomized to the intervention group who received KMC for 2-4 hours daily while intubated and the control group who received care inside an incubator. Participants’ physiologic status – before, during, and after the intervention – was recorded. The primary outcome was mortality. Secondary outcomes included comorbidities, days intubated, and hospital stay. Results. There was a total of 32 patients. The risk of dying in the KMC group (n=16) was significantly reduced by 78% (RR 0.22; 95% CI 0.06 - 0.87 p=0.009). The KMC patients were also less likely to have hypothermia, nosocomial pneumonia, NEC, and late-onset neonatal sepsis (p<0.05). The KMC group had higher blood sugar levels (110 vs. 58, p=0.001) and required fewer days of intubation (3.5 vs.1.5 days, p<0.000) compared to the control group. There was no difference in the duration of the hospital stay. Conclusion. KMC is effective in decreasing mortality among intubated preterm neonates. Other comorbidities and days of intubation were also reduced.

scholarly journals Breastfeeding success with the use of the inverted syringe technique for management of inverted nipples in lactating women: a study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mona Nabulsi ◽  
Rayan Ghanem ◽  
Marlie Abou-Jaoude ◽  
Ali Khalil
Keyword(s):  
Randomized Controlled Trial ◽  
Exclusive Breastfeeding ◽  
Standard Care ◽  
Infant Nutrition ◽  
Controlled Trial ◽  
Intervention Group ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Inverted Nipples

Abstract Background Breastfeeding provides ideal infant nutrition, conferring several health benefits to children and their mothers. Women with inverted nipples, however, face difficulties that force them to prematurely terminate breastfeeding. Whereas available conservative measures for the correction of inverted nipples are of limited success, the use of an inverted syringe may be effective in achieving high rates of infant latching and exclusive breastfeeding. This technique, however, has not been investigated in a clinical trial. Methods/design This open-label randomized controlled trial aims to investigate whether, in women with inverted nipples, the use of an inverted syringe increases the rate of exclusive breastfeeding at one month compared to standard care. One-hundred healthy women with grade 1 or 2 inverted nipples will be recruited as of 37 weeks of gestation. They will be randomly allocated to standard care (control group) or to an intervention group. The intervention consists of using an inverted syringe to evert the nipple before every breastfeed, starting with the first feed after delivery. The primary outcome measure is the rate of exclusive breastfeeding at 1 month. Secondary outcome measures include exclusive breastfeeding rates at 3 and 6 months, nipple eversion rate, successful latching rate, rates of any breastfeeding at 1, 3, and 6 months, breastfeeding-associated complications, maternal satisfaction with breastfeeding, maternal quality of life, and adverse events. Descriptive and regression analysis will be conducted under the intention to treat basis. Discussion The use of the inverted syringe to evert inverted nipples is a simple, inexpensive, and safe technique that can be performed by mothers with inverted nipples. Findings of this trial, if positive, will provide much needed evidence for a safe, affordable, readily available, and simple intervention to treat inverted nipples, and improve breastfeeding practice among affected women. Trial registration ClinicalTrials.gov, NCT03529630. Registered May 8, 2018.

Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert
Keyword(s):  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Pharmacies ◽  
Web Based ◽  
Randomized Controlled ◽  
Tailored Interventions ◽  
Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals Community Health Workers as a Strategy to Tackle Psychosocial Suffering Due to Physical Distancing: A Randomized Controlled Trial

2021 ◽  
Vol 18 (6) ◽  
pp. 3097
Author(s):  
Dorien Vanden Bossche ◽  
Susan Lagaert ◽  
Sara Willems ◽  
Peter Decat
Keyword(s):  
Randomized Controlled Trial ◽  
Community Health ◽  
Health Workers ◽  
Psychosocial Support ◽  
Controlled Trial ◽  
Intervention Group ◽  
Psychosocial Health ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact

Background: During the COVID-19 pandemic, many primary care professionals were overburdened and experienced difficulties reaching vulnerable patients and meeting the increased need for psychosocial support. This randomized controlled trial (RCT) tested whether a primary healthcare (PHC) based community health worker (CHW) intervention could tackle psychosocial suffering due to physical distancing measures in patients with limited social networks. Methods: CHWs provided 8 weeks of tailored psychosocial support to the intervention group. Control group patients received ‘care as usual’. The impact on feelings of emotional support, social isolation, social participation, anxiety and fear of COVID-19 were measured longitudinally using a face-to-face survey to determine their mean change from baseline. Self-rated change in psychosocial health at 8 weeks was determined. Results: We failed to find a significant effect of the intervention on the prespecified psychosocial health measures. However, the intervention did lead to significant improvement in self-rated change in psychosocial health. Conclusions: This study confirms partially the existing evidence on the effectiveness of CHW interventions as a strategy to address mental health in PHC in a COVID context. Further research is needed to elaborate the implementation of CHWs in PHC to reach vulnerable populations during and after health crises.

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