Activity Aprons for Inpatients Requiring Individual Nursing Assignment Care: A Prospective Randomized Controlled Pilot Study

Background: Activity aprons are commercially available products used to occupy patients with dementia at home or in long-term care facilities. We hypothesized that inpatient use of activity aprons could potentially reduce or eliminate behaviors that result in self-harm, increased nursing supervision, and restraint use in an inpatient hospital setting. Methods: A single-center prospective randomized controlled pilot study was performed from July 2015 to November 2016 comparing activity apron plus standard care versus standard care alone. Consecutively enrolled patients were randomized by stratified randomization using age (cutoff: 80 years) and preexisting diagnosis of dementia or cognitive impairment. Primary outcomes were safety and feasibility of apron use. Secondary outcomes included duration of hospitalization postrandomization and individual nursing assignment (IA), time in restraints, nonphysical restraints use, falls, apron-related complications, dismissal destination, and 30-day hospital readmission. Results: Thirty patients were enrolled, with 13 randomized to apron and 17 randomized to the control group. There was no statistically significant reduction in mean length of hospital stay (15.8 vs 21.5 day; P = .40), duration of IA compared to non-apron control group (6.4 vs 9.1, respectively; P = .39), or antipsychotic medication use (61.5% vs 70.6% in control group; P = .60). No complications secondary to apron use were seen. Conclusions: Activity aprons are a safe addition to the standard of care when managing encephalopathic patients in the inpatient setting. These aprons may have a role as part of a comprehensive complement of interventions to address delirium and encephalopathy in hospitalized patients.

Download Full-text

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

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa332 ◽

2020 ◽

Vol 75 (11) ◽

pp. 3373-3378 ◽

Cited By ~ 9

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.

Download Full-text

Efficacy and Safety of Leflunomide for Refractory COVID-19: A Pilot Study

Frontiers in Pharmacology ◽

10.3389/fphar.2021.581833 ◽

2021 ◽

Vol 12 ◽

Author(s):

Qiang Wang ◽

Haipeng Guo ◽

Yu Li ◽

Xiangdong Jian ◽

Xinguo Hou ◽

...

Keyword(s):

Pilot Study ◽

Clearance Rate ◽

Standard Care ◽

Discharge Rate ◽

Controlled Trial ◽

Standard Of Care ◽

Large Sample Size ◽

Efficacy And Safety ◽

Randomized Controlled ◽

To Receive

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may persist in patients with coronavirus disease 2019 (COVID-19) despite receiving standard care.Methods: In this pilot study of hospitalized adult patients (≥18 years of age), with radiologically confirmed pneumonia who were SARS-CoV-2 positive for more than 28 days despite standard care, were assigned to receive standard of care (SOC, grp I) or leflunomide + SOC (grp 2). After 2 weeks, grp 1 and grp 2 patients who continued to be SARS-CoV-2-positive received leflunomide for 14 days while continuing SOC. The primary outcomes were the rate of and time to SARS-CoV-2 clearance and the 14-day and 30-day hospital discharge rate.Results: 12 patients were enrolled in grp 1 and 15 patients were in grp 2. The 14 days SARS-CoV-2 viral clearance rate was 80.0% (12/15) for grp 2 patients receiving leflunomide vs. 16.7% for grp 1 patients (2/12) (p = 0.002). By day 14, the median time to SARS-CoV-2 clearance was 6.0 days (range 1–12, IQR 1–12) for grp 2 patients. In grp 1, two patients converted to viral negative on days 1 and 6 (p = 0.002). The 14-day discharge rate was 73.3% (11/15) for the grp 2 vs. 8.3% (1/12) for grp 1 (p = 0.001). The 30 days discharge rate was 100% (15/15) for the grp 2 vs. 66.7% (8/12) for grp 1. No severe adverse events or deaths were reported.Conclusion: Leflunomide may improve the SARS-CoV-2 clearance rate and discharge rate in patients with refractory COVID-19. The tolerability of the 14–28 days course of treatment with leflunomide is acceptable. These preliminary observations need to be verified by a large sample size and randomized controlled trial.

Download Full-text

Safety and Efficacy of Repurposed Siddha Medicines in Mild, Moderate, and Severe COVID-19 Patients Admitted To a Government Tertiary Hospital Near Chennai, Tamil Nadu– An Open-Labeled, Randomized, Controlled Trial.

10.21203/rs.3.rs-999914/v1 ◽

2021 ◽

Author(s):

Christian G J ◽

Meenakumari Ramasamy ◽

Shanthimalar Ramalingam ◽

Sankar Ganesan ◽

Ravichandran Vadugam Muthusamy ◽

...

Keyword(s):

Treatment Group ◽

Standard Care ◽

Tamil Nadu ◽

Controlled Trial ◽

Standard Of Care ◽

Tertiary Hospital ◽

Control Group ◽

Open Label ◽

Randomized Controlled ◽

Oxygenation Status

Abstract BackgroundCOVID-19 resulted in loss of human lives owing to respiratory failure caused by dysregulated immune system. Though many treatments are evaluated, the most appropriate is yet to be established. We hypothesized accelerated recovery and reduced mortality in mild, moderate and severe COVID-19 with Siddha regimen consisting of natural products.MethodsIn a randomized, controlled open-label trial conducted on 200 hospitalized COVID-19 patients, they were allocated equally to be treated with add-on Siddha regimen with Standard care or only standard care. The primary and secondary end points were accelerated recovery (≤ 7 days) and mortality comparison between the groups respectively. Patients were followed through 90 days.ResultsIn this study the accelerated recovery was 59.0% and 27.0% in treatment and control group (ITT analyses) (p < 0.001) respectively and Odds for it were four times higher in the treatment group (OR: 3.9; 95% CI: 1.9, 8.0). The estimated median time for recovery in the treatment group was 7 days (95% CI: 6.0, 8.0; p=0.003) and 10 days (95% CI: 8.7, 11.3) in control. Hazard ratio for death in control was 2.3 times that of treatment group. No adverse reactions or alarming laboratory values were observed in response to intervention. In severe treatment group (n=80), mortality was 15.0% and 39.5% in control (n=81). The COVID stage progression was 65% less in treatment group.ConclusionSiddha regimen demonstrated that they can synergistically improve oxygenation status, enhance the recovery rate and reduce the mortality better as compared to only Standard of Care.

Download Full-text

Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial

Journal of Antimicrobial Chemotherapy ◽

10.1093/jac/dkaa334 ◽

2020 ◽

Vol 75 (11) ◽

pp. 3379-3385 ◽

Cited By ~ 12

Author(s):

Anahita Sadeghi ◽

Ali Ali Asgari ◽

Alireza Norouzi ◽

Zahedin Kheiri ◽

Amir Anushirvani ◽

...

Keyword(s):

Standard Care ◽

Controlled Trial ◽

Standard Of Care ◽

Control Group ◽

Controlled Clinical Trial ◽

University Hospitals ◽

Open Label ◽

Serious Adverse Events ◽

Clinical Recovery ◽

Randomized Controlled

Abstract Background Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19. Methods This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2. Results Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4–8)] than the control group [8 days (IQR 5–13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray’s P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported. Conclusions The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.

Download Full-text

Rooming-in for Infants at Risk for Neonatal Abstinence Syndrome: Outcomes 5 Years following Its Introduction as the Standard of Care at One Hospital

American Journal of Perinatology ◽

10.1055/s-0040-1719182 ◽

2020 ◽

Author(s):

Adam Isaiah Newman ◽

Dane Mauer-Vakil ◽

Helen Coo ◽

Lynn Newton ◽

Emily Wilkerson ◽

...

Keyword(s):

Pilot Study ◽

Hospital Stay ◽

Pharmacological Treatment ◽

Standard Care ◽

Neonatal Intensive Care ◽

Length Of Hospital Stay ◽

Standard Of Care ◽

Neonatal Abstinence Syndrome ◽

Abstinence Syndrome ◽

Lengths Of Stay

Objective The practice of rooming-in for opioid-dependent infants was introduced as the standard of care at our hospital following a pilot study which demonstrated that such infants had shorter lengths of stay and were less likely to require pharmacological treatment. We sought to determine whether these benefits have continued, and whether outcomes support continuing to use rooming-in as standard care. Study Design Opioid-dependent infants delivered at 36 weeks gestation or later between January 1, 2015, and December 31, 2019, were eligible for rooming-in. Charts were reviewed and data were extracted regarding maternal and infant conditions, whether neonatal pharmacological treatment was required, and total length of hospital stay. Outcomes were compared with two historical groups reported in a previous pilot study: 24 healthy near-term opioid-dependent newborns who were admitted directly to the neonatal intensive care unit (NICU) prior to the introduction of rooming-in (May 1, 2012–May 31, 2013), and 20 similar opioid-dependent infants who were the first to room-in at our hospital (September 1, 2013–September 30, 2014). Results Only 3.5% of 57 infants who roomed-in during the 5-year study period required pharmacological treatment, compared with 15% who roomed-in during the first year of the program's introduction and 83.3% who had been admitted directly to the NICU. The median length of stay remained 5 days for infants rooming-in, compared with 24 days for opioid-dependent infants in the cohort admitted to the NICU. Conclusion Early observations of the benefits of rooming-in on neonatal outcomes were sustained. Infants allowed to room-in were significantly less likely to require initiation of pharmacotherapy and a prolonged hospital stay than similar infants prior to the implementation of rooming-in as standard care. A large proportion of the infants who might have benefited from rooming-in required admission to the NICU for reasons other than neonatal abstinence syndrome (NAS). Key Points

Download Full-text

The Effect of Reflexology on Lactation in Women Who Had Cesarean Section: A Randomized Controlled Pilot Study

Complementary Medicine Research ◽

10.1159/000513924 ◽

2021 ◽

pp. 1-8

Author(s):

Sevde Aksu ◽

Pelin Palas Karaca

Keyword(s):

Pilot Study ◽

Cesarean Section ◽

Intervention Group ◽

Control Group ◽

Breast Pain ◽

Randomized Controlled ◽

Significant Difference ◽

The Right ◽

Documentation Tool ◽

And Control

Aim: The research was conducted as a randomized controlled pilot study to evaluate the effects of reflexology on lactation in mothers who delivered by cesarean section (CS). Methods: A single-blind randomized controlled experimental study was conducted with a total of 60 postpartum women in the reflexology application (n = 30) and control groups (n = 30). After the CS, the mothers in the control group were given approximately 3-h routine nursing care after recovering from the effects of anesthesia; the introductory information form was applied, and the Breastfeeding Charting System and Documentation Tool (LATCH) and visual analog scale (VAS) for the signs of the onset of lactation were implemented on the first and second days. Reflexology was applied to the women in the intervention group after an average of 3 h following the mother’s condition had become stable and she had recovered from the effects of anesthesia. Reflexology was applied a total of 20 min – 10 min for the right foot, 10 min for the left foot – twice a day with 8-h intervals on the first and second days after CS. After the last reflexology application, the LATCH and VAS for the signs of the onset of lactation were applied. Results: Of the women, 70% breastfed their babies within 60 min after delivery; 46.7% of the mothers received breastfeeding training and 81.7% needed support for breastfeeding after the CS. The LATCH breastfeeding scores of the women in the intervention group on both days were significantly higher compared to those of the women in the control group (p < 0.001). On the first day after the CS, apart from breast pain, there was no significant difference between the two groups in terms of breast heat and breast tension (p > 0.05). On the second day after the CS, apart from breast tension, there was no significant difference between the groups in terms of breast heat and breast pain (p < 0.05). In the study, women in the intervention group were found to have higher scores in terms of all three symptoms compared to the control group (p < 0.05). Conclusions: In the study, it was determined that LATCH scores and signs of the onset of breastfeeding increased in the mothers who received reflexology after CS.

Download Full-text

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

BMC Infectious Diseases ◽

10.1186/s12879-021-06045-3 ◽

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).

Download Full-text

A Collaborative Deprescribing Intervention in a Subacute Medical Outpatient Clinic: A Pilot Randomized Controlled Trial

Metabolites ◽

10.3390/metabo11040204 ◽

2021 ◽

Vol 11 (4) ◽

pp. 204

Author(s):

Anissa Aharaz ◽

Jens Henning Rasmussen ◽

Helle Bach Ølgaard McNulty ◽

Arne Cyron ◽

Pia Keinicke Fabricius ◽

...

Keyword(s):

Pilot Study ◽

Controlled Trial ◽

Inappropriate Medication ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Patient Interviews ◽

Number Of Patients ◽

Multimorbid Patients ◽

And Control

Medication deprescribing is essential to prevent inappropriate medication use in multimorbid patients. However, experience of deprescribing in Danish Subacute Medical Outpatient Clinics (SMOCs) is limited. The objective of our pilot study was to evaluate the feasibility and sustainability of a collaborative deprescribing intervention by a pharmacist and a physician to multimorbid patients in a SMOC. A randomized controlled pilot study was conducted, with phone follow-up at 30 and 365+ days. A senior pharmacist performed a systematic deprescribing intervention using the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) criteria, the Danish deprescribing list, and patient interviews. A senior physician received the proposed recommendations and decided which should be implemented. The main outcome was the number of patients having ≥1 medication where deprescribing status was sustained 30 days after inclusion. Out of 76 eligible patients, 72 (95%) were included and 67 (93%) completed the study (57% male; mean age 73 years; mean number of 10 prescribed medications). Nineteen patients (56%) in the intervention group and four (12%) in the control group had ≥1 medication where deprescribing status was sustained 30 days after inclusion (p = 0.015). In total, 37 medications were deprescribed in the intervention group and five in the control group. At 365+ days after inclusion, 97% and 100% of the deprescribed medications were sustained in the intervention and control groups, respectively. The three most frequently deprescribed medication groups were analgesics, cardiovascular, and gastrointestinal medications. In conclusion, a collaborative deprescribing intervention for multimorbid patients was feasible and resulted in sustainable deprescribing of medication in a SMOC.

Download Full-text

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2018-0028 ◽

2018 ◽

Vol 16 (2) ◽

Cited By ~ 2

Author(s):

Ilana Levy ◽

Samuel Attias ◽

Lior Cohen ◽

Nadav Stoppelmann ◽

Dan Steinberger ◽

...

Keyword(s):

Side Effects ◽

Postoperative Pain ◽

Analgesic Effect ◽

Pain Treatment ◽

Standard Of Care ◽

Acupuncture Group ◽

Controlled Study ◽

Control Group ◽

Pain Level ◽

Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

Download Full-text

Effects of self-conditioning techniques in promoting weight loss in patients with severe obesity: a randomized controlled trial protocol

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170304 ◽

2017 ◽

Vol 4 (1) ◽

pp. 20 ◽

Cited By ~ 1

Author(s):

Simona Bo ◽

Farnaz Rahimi ◽

Bice Properzi ◽

Giuseppe Regaldo ◽

Ilaria Goitre ◽

...

Keyword(s):

Weight Loss ◽

Standard Care ◽

Traditional Approach ◽

Controlled Trial ◽

Well Being ◽

Control Group ◽

Randomized Controlled ◽

Rapid Induction ◽

Conditioning Approach

Background: Obesity is a worldwide epidemic; most obese individuals who lose weight after lifestyle educative treatments, soon regain it. Our aim is to evaluate the effectiveness of a training to teach self-conditioning technique (self-hypnosis) added to standard care in determining weight loss compared with standard care in patients with obesityMethods: This randomized controlled open trial will recruit 120 obese patients (BMI 35-50 Kg/m2), aged 20-70 years. The control group will receive a traditional approach: diet + exercise + behavioral recommendations. The experimental group will receive self-conditioning techniques + traditional approach.Three individual sessions of hypnosis with rapid-induction techniques will be administered by trained personnel. All the participants of both groups will be assessed at three, six, nine and twelve months after randomization. The primary outcome is weight loss difference between groups at 12 months after randomization; secondary outcomes are changes in adherence to dietetic and exercise recommendations, appetite and satisfaction/well-being, waist circumference and body fat, blood pressure and blood metabolic and inflammatory variables.Conclusions: The results of this trial will assess whether a self-conditioning approach, based on self-hypnosis, is able to help participants to modulate unhealthy patterns of eating and sustain weight loss in the long term.

Download Full-text