scholarly journals Hyponatremia Intervention Trial (HIT): Study Protocol of a Randomized, Controlled, Parallel-Group Trial With Blinded Outcome Assessment

2021 ◽  
Vol 8 ◽  
Author(s):  
Julie Refardt ◽  
Anissa Pelouto ◽  
Laura Potasso ◽  
Ewout J. Hoorn ◽  
Mirjam Christ-Crain
Keyword(s):  
Outcome Assessment ◽  
Controlled Trial ◽  
Plasma Sodium ◽  
Clinical Equipoise ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Risk Of Mortality ◽  
Parallel Group ◽  
Increased Risk ◽  
Chronic Hyponatremia

Background: Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. In contrast to acute hyponatremia where the need for immediate treatment is well-recognized, chronic hyponatremia is often considered not clinically relevant. This is illustrated by reports showing that appropriate laboratory tests are ordered in <50% of patients and that up to 75% are still hyponatremic at discharge. At the same time, emerging evidence suggests an association between hyponatremia and adverse events including increased risk of mortality and rehospitalization.Methods: This is a randomized (1:1 ratio) controlled, superiority, parallel-group international multi-center trial with blinded outcome assessment. In total 2,278 participants will be enrolled. Participants will be randomly assigned to undergo either targeted correction of plasma sodium levels or standard of care during hospitalization. The primary outcome is the combined risk of death or re-hospitalization within 30 days.Discussion: All data on hyponatremia and mortality are derived from observational studies and often lack methodologic robustness. Consequently, the direct impact of hyponatremia on mortality and rehospitalization risk is still debated, resulting in a clinical equipoise whether in-hospital chronic hyponatremia should be treated or not. Therefore, a randomized controlled trial is required to study whether targeted plasma sodium correction reduces the risk of mortality and rehospitalization associated with hyponatremia.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03557957.

Should all Hypertensive Patients be Screened for Primary Aldosteronism?

2019 ◽  
Vol 15 (1) ◽  
pp. 54-56
Author(s):  
Stelina Alkagiet ◽  
Konstantinos Tziomalos
Keyword(s):  
Resistant Hypertension ◽  
Primary Aldosteronism ◽  
Large Scale ◽  
Controlled Trial ◽  
The Other ◽  
Limited Data ◽  
Hypertensive Patients ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Prospective Randomized Controlled Trial

Primary aldosteronism (PA) is not only a leading cause of secondary and resistant hypertension, but is also quite frequent in unselected hypertensive patients. Moreover, PA is associated with increased cardiovascular risk, which is disproportionate to BP levels. In addition, timely diagnosis of PA and prompt initiation of treatment attenuate this increased risk. On the other hand, there are limited data regarding the usefulness of screening for PA in all asymptomatic or normokalemic hypertensive patients. More importantly, until now, no well-organized, large-scale, prospective, randomized controlled trial has proved the effectiveness of screening for PA for improving clinical outcome. Accordingly, until more relevant data are available, screening for PA should be considered in hypertensive patients with spontaneous or diuretic-induced hypokalemia as well as in those with resistant hypertension. However, screening for PA in all hypertensive patients cannot be currently recommended.

Measuring Acceptability and Engagement of the Keep It Up! Internet-based HIV Prevention Randomized Controlled Trial for Young Men who have Sex with Men (Preprint)

2018 ◽  
Author(s):  
Krystal Madkins ◽  
David Moskowitz ◽  
Kevin Moran ◽  
Trey Dellucci ◽  
Brian Mustanski
Keyword(s):  
High School ◽  
Randomized Controlled Trial ◽  
Hiv Prevention ◽  
Controlled Trial ◽  
P Values ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Intervention Acceptability ◽  
Intervention Content ◽  
Sex With Men

BACKGROUND Since 2010, HIV diagnoses among men who have sex with men (MSM) have remained stably high while decreasing for heterosexual men and women. The burden of infection has disproportionately impacted younger MSM of color relative to other populations. Despite the increased risk, there are few HIV prevention programs targeted to diverse and young MSM. The Keep It Up! (KIU!) online intervention was created to address the HIV prevention needs of this population. OBJECTIVE The objective of this study was to examine the acceptability and engagement of KIU!, and explore any differences by demographics, within the context of a randomized controlled trial (RCT). METHODS Between May 2013 and December 2015, 445 participants were randomized into the intervention arm of the KIU! RCT. Data were taken from the baseline assessment, KIU! 2.0 intervention modules, and immediate post-test assessments of intervention acceptability and engagement. Outcomes of interests were qualitative and quantitative measures of intervention acceptability and engagement as well as process measures (i.e., star ratings of intervention content and paradata on time spent in intervention). RESULTS Participants were an average of 24 years old, 62.9% (280/445) identified as a racial or ethnic minority, 86.5% (385/445) identified as gay, and 84.3% (375/445) reported having at least some college education. Most participants rated the intervention content highly (4 out of 5 stars) and gave the intervention an average acceptability score of 3.5 out of 4. Compared to White participants, Black participants found the intervention more useful (p = .03), engaging (p < .001), and acceptable (p = .001); Latino participants found the intervention more engaging (p = .03); and “other” non-White participants found the intervention more engaging (p = .008) and acceptable (p = .02). Participants with high school or less education found the intervention more useful, engaging, and acceptable, and were more likely to give intervention content a five star rating than college educated participants (p-values = .047, <.001, .002, .01 respectively) or those with graduate degrees (p-values = .04, .001, < .001, .004 respectively). White participants showed the most variation between education levels and reporting positive attitudes towards the intervention. Among Black participants, graduate degree-earning participants spent significantly more time on the intervention than high-school or less educated participants (p = .02). CONCLUSIONS Overall, participants gave the intervention high acceptability and engagement ratings; but it was most acceptable and engaging to participants who were younger, identified as racial and ethnic minorities, had less education, and lived in the South. As these are all groups with greater burden of HIV infection, the KIU! intervention is promising as a primary HIV prevention tool. Future implementations of KIU! are needed to assess its acceptability outside of the highly controlled environment of an RCT. CLINICALTRIAL RCT# NCT01836445

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 An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals Protocol of a Multi-centric Randomized Controlled Trial to Evaluate Efficacy of Telephone-Based Psychosocial Interventions on Future Suicide Risk in Suicide Attempters

2020 ◽  
Vol 42 (6_suppl) ◽  
pp. S39-S45
Author(s):  
Ram Pratap Beniwal ◽  
Priya Sreedaran ◽  
Uttara Chari ◽  
Ashok MV ◽  
Triptish Bhatia
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Treatment ◽  
Suicide Attempts ◽  
Controlled Trial ◽  
Psychosocial Interventions ◽  
Health Treatment ◽  
Risk Of Death ◽  
Randomized Controlled ◽  
Telephone Reminders

Background: Persons with previous history of a suicide attempt are at increased future risk of death by suicide. These vulnerable individuals, however, do not seek receive or seek help from mental health services. Telephone-based psychosocial interventions are potential strategies in augmenting mental health care in such persons. Methods: We aim to compare the efficacy of telephone-based psychosocial interventions (TBPI) with routine telephone reminders in persons with recent suicide attempts using a multi-site, parallel group, rater-blind, two-arm randomized controlled trial design in 362 participants. In the first group, participants will receive three sessions of TBPI comprising of brief supportive interventions, problem-solving strategies, and reminders for adherence to prescribed mental health treatment at weekly intervals. In the second group, participants will receive three telephone reminders for adherence to prescribed mental health treatment at weekly intervals. We will follow up participants for 6 months. Primary outcomes are suicidal ideation scores on Beck’s Scale for Suicide Ideation and number of repeat suicide attempts. Secondary outcomes are scores on Beck’s Hopelessness Scale, Beck’s Depression Inventory, Connor–Davidson Resilience Scale and Visual Analogue Rating Scales for acceptability of interventions. Outcomes will be assessed at 1, 3, and 6 months after receiving telephone interventions or reminders. Results: The trial is currently underway after prospective registration under Clinical Trials Registry of India and has recruited 260 participants till August 15, 2020. Conclusion: This study has potential to generate evidence on additional strategies for use along with standard mental health treatments in management of high-risk suicide behaviors.

scholarly journals 416 - Risk of Mortality Associated with Antipsychotics in Alzheimer's Disease

2020 ◽  
Vol 32 (S1) ◽  
pp. 132-132
Author(s):  
Liliana P. Ferreira ◽  
Núria Santos ◽  
Nuno Fernandes ◽  
Carla Ferreira
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Mortality Risk ◽  
Antipsychotic Treatment ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Mesh Terms ◽  
Risk Of Mortality ◽  
Increased Risk

Objectives: Alzheimer's disease (AD) is the most common cause of dementia and it is associated with increased mortality. The use of antipsychotics is common among the elderly, especially in those with dementia. Evidence suggests an increased risk of mortality associated with antipsychotic use. Despite the short-term benefit of antipsychotic treatment to reduce the behavioral and psychological symptoms of dementia, it increases the risk of mortality in patients with AD. Our aim is to discuss the findings from the literature about risk of mortality associated with the use of antipsychotics in AD.Methods: We searched Internet databases indexed at MEDLINE using following MeSH terms: "Antipsychotic Agents" AND "Alzheimer Disease" OR "Dementia" AND "Mortality" and selected articles published in the last 5 years.Results: Antipsychotics are widely used in the pharmacological treatment of agitation and aggression in elderly patients with AD, but their benefit is limited. Serious adverse events associated with antipsychotics include increased risk of death. The risk of mortality is associated with both typical and atypical antipsychotics. Antipsychotic polypharmacy is associated with a higher mortality risk than monotherapy and should be avoided. The mortality risk increases after the first few days of treatment, gradually reducing but continues to increase after two years of treatment. Haloperidol is associated with a higher mortality risk and quetiapine with a lower risk than risperidone.Conclusions: If the use of antipsychotics is considered necessary, the lowest effective dose should be chosen and the duration should be limited because the mortality risk remains high with long-term use. The risk / benefit should be considered when choosing the antipsychotic. Further studies on the efficacy and risk of adverse events with antipsychotics are needed for a better choice of treatment and adequate monitoring with risk reduction.

scholarly journals The ACHIEVE Trial: Lessons Learned From Nesting a Randomized Controlled Trial Within an Observational Cohort Study

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Observational Study ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Study Staff ◽  
Increased Risk

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.

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