Resourcefulness Intervention Efficacy for Parent Caregivers of Technology-Dependent Children: A Randomized Trial

2021 ◽  
pp. 019394592110629
Author(s):  
Valerie Boebel Toly ◽  
Jaclene A. Zauszniewski ◽  
Jiao Yu ◽  
Abdus Sattar ◽  
Bethany Rusincovitch ◽  
...  
Keyword(s):  
Physical Health ◽  
Help Seeking ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Attention Control ◽  
Current Standard ◽  
Dependent Children ◽  
Time Points ◽  
Intervention Efficacy ◽  
Parent Caregivers

Parent caregivers of children who require lifesaving technology (e.g., mechanical ventilation, feeding tubes) must maintain a high level of vigilance 24/7. A two-arm randomized controlled trial tested the efficacy of a resourcefulness intervention on parents’ mental/physical health and family functioning at four time points over six months. Participants ( n = 93) cared for their technology-dependent children <18 years at home. The intervention arm received teaching on social (help-seeking), personal (self-help) resourcefulness skills; access to the intervention video and skill application video-vignettes; four weeks of skills reinforcement using daily logs; four weekly phone contacts; and booster sessions at two- and four-month postenrollment. The attention control arm received phone contact at identical time points plus the current standard of care. Statistically significant improvement was noted; fewer depressive cognitions and improved physical health for the intervention participants than attention control participants over time after controlling for covariates. The findings support the resourcefulness intervention efficacy.

scholarly journals SAT-500 Response to Tocilizumab Retreatment in Refractory Thyroid Eye Disease

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Daniel Kaplan ◽  
Benjamin Erickson ◽  
Andrea Kossler ◽  
Julie Chen ◽  
Chrysoula Dosiou
Keyword(s):  
Controlled Trial ◽  
Standard Of Care ◽  
Thyroid Eye Disease ◽  
Eye Disease ◽  
Clinical Activity ◽  
Current Standard ◽  
Compressive Optic Neuropathy ◽  
Effective Option ◽  
Graves Orbitopathy ◽  
Recurrent Inflammation

Abstract Background: The current standard of care for moderate to severe thyroid eye disease (TED) is intravenous methylprednisolone (IVMP), though alternative immunosuppressive options are emerging. In a recent randomized trial, Tocilizumab (TCZ), an anti-IL-6 receptor antibody, demonstrated improved efficacy for corticosteroid-resistant TED compared to placebo. Clinical response to TCZ retreatment, however, has not been previously reported. Clinical case: A 64-year old man presented with progressive diplopia, eyelid retraction and edema and retrobulbar pain. Initial labs revealed TSH 0.221 uIU/mL, free thyroxine (FT4) 1.11 ng/dL, total T3 172 ng/dL and a thyroid stimulating immunoglobulin (TSI) index of 329 (normal &lt; 140). The patient was a former cigarette smoker who had recently transitioned to e-cigarettes. He was treated with 12 weeks of IVMP with improvement in ocular redness and swelling. Three months following completion of treatment, he presented with worsening left sided proptosis, restrictive strabismus, and compressive optic neuropathy (CON) evidenced by deteriorating central acuity and color vision. He underwent urgent surgical decompression for CON with full restoration of visual acuity. He then received a second 12-week course of IVMP with concomitant orbital radiation. Of note, his hyperthyroidism was well controlled with methimazole. Two months after his second IVMP course, he had a third flare of ophthalmic symptoms. He was then treated with TCZ 8 mg/kg (800mg) IV monthly for six months. The patient’s Clinical Activity Score (CAS) improved from 4 to 2 and TSI index decreased from 610 to 92 (normal). He had significant improvement in periorbital edema, caruncle/plica swelling, and conjunctival injection. However, ten months following completion of the TCZ course he again complained of worsening diplopia and left proptosis. Of note, relapse of his TED symptoms was preceded by an increase in TSI from 92 to 300 two months prior. Orbital CT demonstrated progression of left orbitopathy and increased orbital apex crowding. Following these CT findings he was restarted on TCZ, of which he has now completed 5 additional infusions. His CAS has improved from 3 to 2 and TSI index has decreased from 284 to 100. Conclusion: This is the first reported case of response to successive courses of TCZ in relapsing, severe, corticosteroid-resistant TED. TCZ can be an effective option for refractory TED though retreatment may be necessary for recurrent inflammation. Further study of TCZ is required to determine its role in relapsing TED and the optimal duration of therapy needed. References: Perez-Moreiras et al., 2018. Efficacy of Tocilizumab in patients with moderate to severe corticosteroid resistant Graves’ orbitopathy: a randomized controlled trial. Am J Ophthalmol 195:181

scholarly journals High dose oral and intravenous rifampicin for improved survival from adult tuberculous meningitis: a phase II open-label randomised controlled trial (the RifT study)

2018 ◽  
Vol 3 ◽  
pp. 83 ◽  
Author(s):  
Fiona V. Cresswell ◽  
Kenneth Ssebambulidde ◽  
Daniel Grint ◽  
Lindsey te Brake ◽  
Abdul Musabire ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Phase Ii ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Hiv Positive ◽  
Current Standard ◽  
Open Label ◽  
Dose Oral ◽  
Randomised Controlled ◽  
Positive Population

Background: Tuberculous meningitis (TBM) has 44% (95%CI 35-52%) in-hospital mortality with standard therapy in Uganda. Rifampicin, the cornerstone of TB therapy, has 70% oral bioavailability and ~10-20% cerebrospinal fluid (CSF) penetration.  With current WHO-recommended TB treatment containing 8-12mg/kg rifampicin, CSF rifampicin exposures frequently fall below the minimal inhibitory concentration for M. tuberculosis. Two Indonesian phase II studies, the first investigating intravenous rifampicin 600mg and the second oral rifampicin ~30mg/kg, found the interventions were safe and resulted in significantly increased CSF rifampicin exposures and a reduction in 6-month mortality in the investigational arms. Whether such improvements can be replicated in an HIV-positive population remains to be determined. Protocol: We will perform a phase II, open-label randomised controlled trial, comparing higher-dose oral and intravenous rifampicin with current standard of care in a predominantly HIV-positive population. Participants will be allocated to one of three parallel arms (I:I:I): (i) intravenous rifampicin 20mg/kg for 2-weeks followed by oral rifampicin 35mg/kg for 6-weeks; (ii) oral rifampicin 35mg/kg for 8-weeks; (iii) standard of care, oral rifampicin 10mg/kg/day for 8-weeks. Primary endpoints will be: (i) pharmacokinetic parameters in plasma and CSF; (ii) safety. We will also examine the effect of higher-dose rifampicin on survival time, neurological outcomes and incidence of immune reconstitution inflammatory syndrome. We will enrol 60 adults with suspected TBM, from two hospitals in Uganda, with follow-up to 6 months post-enrolment. Discussion: HIV co-infection affects the bioavailability of rifampicin in the initial days of therapy, risk of drug toxicity and drug interactions, and ultimately mortality from TBM. Our study aims to demonstrate, in a predominantly HIV-positive population, the safety and pharmacokinetic superiority of one or both investigational arms compared to current standard of care. The most favourable dose may ultimately be taken forward into an adequately powered phase III trial. Trial registration: ISRCTN42218549 (24th April 2018)

scholarly journals Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lenka A. Vodstrcil ◽  
◽  
Erica L. Plummer ◽  
Michelle Doyle ◽  
Christopher K. Fairley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bacterial Vaginosis ◽  
Controlled Trial ◽  
Male Partner ◽  
Standard Of Care ◽  
Trial Registration ◽  
Current Standard ◽  
Randomised Controlled ◽  
Oral Metronidazole ◽  
Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

scholarly journals ACTION-1: study protocol for a randomised controlled trial on ACT guided heparinization during open abdominal aortic aneurysm repair {1}

2021 ◽  
Author(s):  
Arno M. Wiersema ◽  
Liliane C. Roosendaal ◽  
Mark J.W. Koelemaij ◽  
Jan G.P. Tijssen ◽  
Susan van Dieren ◽  
...  
Keyword(s):  
Abdominal Aortic Aneurysm ◽  
Aortic Aneurysm ◽  
Major Bleeding ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Abdominal Aortic Aneurysm Repair ◽  
Bleeding Complications ◽  
Current Standard ◽  
Single Bolus ◽  
Abdominal Aortic

Abstract BackgroundHeparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The Activated Clotting Time (ACT) can measure the effect of heparin. Currently this ACT is not measured during NCAP as standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT guided heparinization results in less TEC than the current standard: a single bolus of 5 000 IU of heparin and no measurements at all. A goal ACT of 200-220 seconds should be reached during ACT guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe.MethodsSeven-hundred-fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5 000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min., and then every 30 min. Goal ACT is 200-220 sec. If the ACT after 5 min. is < 180 sec. 60 IU/kg will be administered, if the ACT is between 180 and 200 sec. 30 IU/kg. If the ACT is > 220 sec. no extra heparin is given, and the ACT is measured after 30 minutes and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5 000 IU group and 11% for the ACT guided group.DiscussionThe ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT guided heparinization compared to the current standard of a single bolus of 5 000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit.Trial registration {2a}NTR: NL8421Clinicaltrials.gov: NCT04061798. Date of registration: 20-08-2019. https://clinicaltrials.gov/ct2/show/NCT04061798?cond=NCT04061798&draw=2&rank=1 EudraCT: 2018-003393-27

scholarly journals Does Neuromuscular Electrical Stimulation Improve Recovery Following Acute Ankle Sprain? A Pilot Randomised Controlled Trial

2019 ◽  
Vol 12 ◽  
pp. 117954411984902 ◽  
Author(s):  
Thomas W Wainwright ◽  
Louise C Burgess ◽  
Robert G Middleton
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trial ◽  
Ankle Sprain ◽  
Controlled Trial ◽  
Neuromuscular Electrical Stimulation ◽  
Standard Of Care ◽  
Controlled Study ◽  
Current Standard ◽  
Pilot Randomised Controlled Trial ◽  
Randomised Controlled

Aim: Following soft tissue ankle injury, patients are often referred for out-patient physiotherapy and present symptoms including pain, reduced range of movement and function, and oedema. In this study, we assess the use of a neuromuscular electrical stimulation (NMES) device as an adjunctive therapy to reduce oedema in patients recovering from grade I and II ankle sprains. Methods: This was a single-centre, pilot randomised controlled study, recruiting patients referred to physiotherapy following an ankle sprain. Participants presenting with oedema were randomised to one of two treatment groups: (1) the current standard of care and (2) the current standard of care plus NMES use. Participants were identified in an emergency department and referred to a physiotherapy department for treatment 1 to 5 days following the injury and returned to clinic 7 days later. Results: Twenty-two participants completed the study and had full data sets for analysis (11 in each group). Mean volumetric displacement was reduced in the intervention group in comparison to the standard care group ( P = .011); however, there were no between-group differences in figure of eight measurements, function or pain scores. The device was well tolerated, with no device-related adverse events recorded. Conclusions: In this pilot, randomised controlled trial, NMES was well tolerated by patients following ankle sprain and demonstrated statistically significant improvements in oedema reduction as measured by fluid displacement. No other changes were observed. Further work will need to confirm the clinical significance and effect on longer term recovery post-ankle sprain.

scholarly journals The CIPAZ study protocol: an open label randomised controlled trial of azithromycin versus ciprofloxacin for the treatment of children hospitalised with dysentery in Ho Chi Minh City, Vietnam

2020 ◽  
Vol 5 ◽  
pp. 214
Author(s):  
Thomas C. Darton ◽  
Tran Thi Hong Chau ◽  
Christopher M. Parry ◽  
James I. Campbell ◽  
Nguyen Minh Ngoc ◽  
...  
Keyword(s):  
Study Protocol ◽  
Bacillary Dysentery ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Ho Chi Minh City ◽  
Ethical Review ◽  
Current Standard ◽  
Open Label ◽  
Children's Hospital ◽  
Children’S Hospital

Background: Diarrhoeal disease remains a common cause of illness and death in children <5 years of age. Faecal-oral infection by Shigella spp. causing bacillary dysentery is a leading cause of moderate-to-severe diarrhoea, particularly in low and middle-income countries. In Southeast Asia, S. sonnei predominates and infections are frequently resistant to first-line treatment with the fluoroquinolone, ciprofloxacin. While resistance to all antimicrobials is increasing, there may be theoretical and clinical benefits to prioritizing treatment of bacillary dysentery with the azalide, azithromycin. In this study we aim to measure the efficacy of treatment with azithromycin compared with ciprofloxacin, the current standard of care, for the treatment of children with bacillary dysentery. Methods and analysis: We will perform a multicentre, open-label, randomized controlled trial of two therapeutic options for the antimicrobial treatment of children hospitalised with dysentery. Children (6–60 months of age) presenting with symptoms and signs of dysentery at Children’s Hospital 2 in Ho Chi Minh City will be randomised (1:1) to treatment with either oral ciprofloxacin (15mg/kg/twice daily for 3 days, standard-of-care) or oral azithromycin (10mg/kg/daily for 3 days). The primary endpoint will be the proportion of treatment failure (defined by clinical and microbiological parameters) by day 28 (+3 days) and will be compared between study arms by logistic regression modelling using treatment allocation as the main variable. Ethics and dissemination: The study protocol (version 1.2 dated 27th December 2018) has been approved by the Oxford Tropical Research Ethics Committee (47–18) and the ethical review boards of Children's Hospital 2 (1341/NĐ2-CĐT). The study has also been approved by the Vietnamese Ministry of Health (5044/QĐ-BYT). Trial registration: Clinicaltrials.gov: NCT03854929 (February 26th 2019).

scholarly journals Protocol for a multicentre randomized controlled trial of normobaric versus hyperbaric oxygen therapy for hypoxemic COVID-19 patients

2020 ◽  
Author(s):  
Sylvain Boet ◽  
Rita Katznelson ◽  
Lana A. Castelluci ◽  
Dean Fergusson ◽  
Michael Gonevski ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Intensive Care ◽  
Oxygen Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Supplemental Oxygen ◽  
High Flow ◽  
Oxygen Supplementation ◽  
Current Standard

Background: At least 1 in 6 COVID-19 patients admitted to hospital and receiving supplemental oxygen will die of complications. More than 50% of patients with COVID-19 that receive invasive treatment such as mechanical ventilation will die in hospital. Such impacts overwhelm the limited intensive care unit resources and may lead to further deaths given inadequate access to care. Hyperbaric oxygen therapy (HBOT) is defined as breathing 100% oxygen at a pressure higher than 1.4 atmosphere absolute (ATA). HBOT is safe, including for lungs, when administered by experienced teams and is routinely administrated for a number of approved indications. Preliminary clinical evidence suggests clinical improvement when hypoxemic COVID-19 patients are treated with HBOT. Objective: We aim to determine the effectiveness of HBOT for improving oxygenation, morbidity, and mortality among hypoxemic COVID-19 patients. Methods and analysis: This trial is a sequential Bayesian Parallel-group, individually Randomized, Open, Blinded Endpoint controlled trial. Admitted hypoxemic COVID-19 patients who require supplemental oxygen (without high flow and mechanical ventilation) to maintain a satisfying tissue oxygenation will be eligible to participate. The anticipated sample size of 234 patients is informed by data from a treatment trial of COVID patients recently published. The intervention group will receive one HBOT per day at 2.0 ATA for 75 minutes. Daily HBOT will be administered until either the patient does not require any oxygen supplementation or requires any type of mechanical ventilation or high flow oxygenation until day 28 post-randomization. Patients in the control group will receive the current standard of care treatment (no HBOT). The primary outcome of this trial will be the 7-level COVID ordinal outcomes scale assessed on Day 7 post-randomization. Secondary outcomes will include: (a) clinical outcomes (length of hospital stay, days with oxygen supplementation, oxygen flow values to obtain a saturation by pulse oximetry ≥90%, intensive care admission and length of stay, days on invasive mechanical ventilation or high flow oxygen, sleep quality, fatigue, major thrombotic events, the 7-level COVID ordinal outcomes scale on Day 28; mortality, safety); (b) biological outcomes (plasma inflammatory markers); and (c) health system outcomes (cost of care and cost-effectiveness). Predetermined inclusion/exclusion criteria have been specified. The analytical approach for the primary outcome will use a Bayesian proportional odds ordinal logistic semiparametric model. The primary analysis will be by intention-to-treat. Bayesian posterior probabilities will be calculated every 20 patients to assess accumulating evidence for benefit or harm. A planned subgroup analysis will be performed for pre-specified variables known to impact COVID-19 prognosis and/or HBOT (biologic sex and age). Discussion: Based on the mortality rate and substantial burden of COVID-19 on the healthcare system, it is imperative that solutions be found. HBOT is a non-invasive and low-risk intervention when contraindications are respected. The established safety and relatively low cost of providing HBOT along with its potential to improve the prognosis of severe COVID-19 patients make this intervention worth studying, despite the current limited number of HBOT centres. If this trial finds that HBOT significantly improves outcome and prevents further deterioration leading to critical care for severe COVID-19 patients, practice will change internationally. If no benefit is found from the intervention, then the current standard of care (no HBOT) will be supported by level I evidence.

scholarly journals Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ralph J. DiClemente ◽  
Jennifer L. Brown ◽  
Ariadna Capasso ◽  
Natalia Revzina ◽  
Jessica M. Sales ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Alcohol Consumption ◽  
Alcohol Use ◽  
Controlled Trial ◽  
Clinical Care ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Intervention Efficacy ◽  
Computer Based ◽  
Alcohol Reduction

Abstract Background Russia has a high prevalence of human immunodeficiency virus (HIV) infections. In 2018, over one million persons were living with HIV (PLWH); over a third were women. A high proportion of HIV-infected women are co-infected with hepatitis C virus (HCV), and many consume alcohol, which adversely affects HIV and HCV treatment and prognosis. Despite the triple epidemics of alcohol use, HIV and HCV, and the need for interventions to reduce alcohol use among HIV/HCV co-infected women, evidence-based alcohol reduction interventions for this vulnerable population are limited. To address this gap, we developed a clinical trial to evaluate the efficacy of a computer-based intervention to reduce alcohol consumption among HIV/HCV co-infected women in clinical care. Methods In this two-arm parallel randomized controlled trial, we propose to evaluate the efficacy of a culturally adapted alcohol reduction intervention delivered via a computer for HIV/HCV co-infected Russian women. The study population consists of women 21–45 years old with confirmed HIV/HCV co-infection who currently use alcohol. Intervention efficacy is assessed by a novel alcohol biomarker, ethyl glucuronide (EtG), and biomarkers of HIV and HCV disease progression. Women are randomized to trial conditions in a 1:1 allocation ratio, using a computer-generated algorithm to develop the assignment sequence and concealment of allocation techniques to minimize assignment bias. Women are randomized to either (1) the computer-based alcohol reduction intervention or (2) the standard-of-care control condition. We will use an intent-to-treat analysis and logistic and linear generalized estimating equations to evaluate intervention efficacy, relative to the standard of care, in enhancing the proportion of women with a laboratory-confirmed negative EtG at each research study visit over the 9-month follow-up period. Additional analyses will evaluate intervention effects on HIV (viral load and CD4+ levels) and HCV markers of disease progression (FibroScan). Discussion The proposed trial design and analysis provides an appropriate conceptual and methodological framework to assess the efficacy of the computer-based intervention. We propose to recruit 200 participants. The intervention, if efficacious, may be an efficient and cost-effective alcohol reduction strategy that is scalable and can be readily disseminated and integrated into clinical care in Russia to reduce women’s alcohol consumption and enhance HIV/HCV prognosis. Trial registration ClinicalTrials.gov NCT03362476. Registered on 5 December 2017

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