Hydroxychloroquine Plus Standard Personal Protective Equipment Versus Standard Personal Protective Equipment Alone for the Prevention of Laboratory Confirmed Covid-19 Infections Among Healthcare Workers: A Multi-Centre Parallel Group Randomized Controlled Trial from India

2021 ◽  
Author(s):  
Bharath Kumar Tirupakuzhi Vijavaraghavan ◽  
Vivekanand Jha ◽  
Dorrilyn Rajbhandari ◽  
Sheila Nainan Myatra ◽  
Arpita Ghosh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Personal Protective Equipment ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Protective Equipment ◽  
Randomized Controlled ◽  
Parallel Group

scholarly journals Statistical Analysis Plan for the HydrOxychloroquine Prophylaxis Evaluation (HOPE) trial

2021 ◽  
Author(s):  
Arpita Ghosh ◽  
Amritendu Bhattacharya ◽  
Vivekanand Jha ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan ◽  
Abhinav Bassi ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Healthcare Workers ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Protective Equipment ◽  
Standard Practice ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Detailed Statistical Analysis ◽  
Frontline Healthcare Workers

HOPE is a prospective, multi-centre, parallel group, concealed, unblinded, randomized, controlled trial to determine whether combination of hydroxychloroquine and standard practice, that is, use of recommended personal protective equipment reduces the proportion of laboratory confirmed COVID-19 infections among frontline healthcare workers in hospitals in India as compared to standard practice. This detailed statistical analysis plan was prepared by trial statisticians and approved by the HOPE management committee prior to completion of data collection.

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.

Furosemide and Albumin for Diuresis of Edema (FADE): A parallel-group, blinded, pilot randomized controlled trial

2018 ◽  
Vol 48 ◽  
pp. 462-467 ◽  
Author(s):  
Simon J.W. Oczkowski ◽  
Lisa Klotz ◽  
Ian Mazzetti ◽  
Fayez Alshamsi ◽  
Mei Lin Chen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Pilot Randomized Controlled Trial
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