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Displaying records 1 - 10 of 17
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  1. COVID-19 Real-time Symptom Epidemiology Tracker (CORSET): Protocol
    Source: Mongan Institute [Massachusetts General Hospital]
    Date Published: 2/8/2021
    Format: Text
    Annotation: The proposed study will contact health care professionals working at Mass General Brigham (Partners Healthcare) or participants enrolled in the Harvard Nurses' Health Study, Harvard Nurses' Health Study II, Harvard Nurses' Health Study III (NHSII/NHSIII), Growing Up Today Study (GUTS), Health Professionals Follow-up Study (HPFS), American Cancer Society Cancer Prevention Study 3 cohorts and direct them to use "COVID-19 Symptom Tracker," a novel app for mobile devices designed to specifically capture self-reported information regarding symptoms associated with COVID-19 and use of PPE during the current COVID-19 pandemic.

    Language(s): English

    This is the protocol for the COVID Symptom Tracker App: https://dr2.nlm.nih.gov/search/?q=21648
    URL: https://disasterinfo.nlm.nih.gov/content/files/CORSET_DetailedProtocol_v1.9_clean.docx
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: predict@mgh.harvard.edu
    Includes Research Tools: Yes.
    ID: 24213. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  2. Coronagenes: Protocol
    Source: University of Edinburgh
    Date Published: 2/8/2021
    Format: Text
    Annotation: An international population cohort to investigate genetic susceptibility to the novel coronavirus (COVID-19). This study seeks to recruit new participants from the general population during the COVID-19 pandemic into a large genetic epidemiological cohort. Recruitment (and subsequent saliva sampling and antibody testing) will take place remotely. Coronagenes re-purposes much of the infrastructure and expertise from the VIKING II study. This launched in January 2020 and paused in March 2020 due to the pandemic, with over 4,000 participants registered. In Coronagenes, data will be collected at baseline through an online questionnaire and longitudinally for UK participants through linkage to routine NHS data (and where possible other healthcare system data) in electronic health records (EHR).

    Language(s): English    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/2020-04-28%20Protocol%20Coronagenes.doc
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    The is the protocol for the Coronagenes Study: https://dr2.nlm.nih.gov/search/?q=24210

    Available Formats: Text

    Contact Information: Jim Wilson, Professor of Human Genomics, University of Edinburgh Email: jim.wilson@ed.ac.uk
    Includes Research Tools: Yes.
    ID: 24215. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  3. ISARIC Global COVID-19 Follow Up Study Protocol
    Source: International Severe Acute Respiratory and emerging Infection Consortium (ISARIC)
    Date Published: 11/17/2020
    Format: Text
    Annotation: The ISARIC COVID-19 Long term protocol & Case Report Form (CRF) survey is designed to follow up adults and children with COVID-19 over time. It can be used for one off or serial follow up of patients post-hospital discharge and for people who were not hospitalized. It is designed to enable patient self-assessment or clinical led assessment, via post, telephone, online or in-clinic visit for wide dissemination and inclusion using limited resources. It can be combined with sampling and further diagnostics. 

    Includes Common Data Elements From: No
    Population: Patients included in the ISARIC/WHO clinical characterisation study, with a confirmed COVID-19 diagnosis post-discharge at serial intervals
    Language(s): English    ...[See more] [See less]
    URL: https://isaric.org/research/covid-19-clinical-research-resources/covid-19-long-term-follow-up-study/
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Available Formats: Text

    Contact Information: ncov@isaric.org
    Includes Research Tools: Yes.
    ID: 24242. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  4. Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) COVID-19 Survey Protocol
    Source: National Institute on Drug Abuse (NIDA)
    Date Published: 6/18/2020
    Format: PDF
    Annotation: This document is the protocol for the "Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO) Survey of COVID-19 Risks/Effects, Substance Use, and HIV/AIDS Survey" (https://dr2.nlm.nih.gov/search/?q=22690). The protocol provides the background, study design, preliminary studies, recruitment and participant sampling, study procedures, data collection and measurements, and analytic strategy....[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/C3PNO_COVID-19_Supplement_Protocol.pdf
    Type: Study Design/Protocol
    Includes Research Tools: Yes.
    ID: 24241. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  5. International Sexual Health And REproductive (I-SHARE) Health Survey during COVID-19: Study Protocol for Online National Surveys and Global Comparative Analyses
    Source: Academic Network for Sexual and Reproductive Health and Rights Policy [Ghent University] (ANSER)
    Date Published: 6/2020
    Format: PDF
    Annotation: COVID-19 may have a profound impact on sexual behaviors, reproductive health, and social life across the world. Shelter-in-place regulations that have extended across the globe may influence condomless sex, exacerbate intimate partner violence, and reduce access to essential reproductive health services. Population-representative research is challenging during shelter-in-place, leaving major gaps in our understanding of sexual and reproductive health during COVID-19. This International Sexual Health And REproductive (I-SHARE) study protocol manuscript describes a common plan for online national surveys and global comparative analyses.

    Methods: The purpose of this cross-sectional study is to better understand sexual and reproductive health in selected countries during COVID-19 and facilitate multi-national comparisons. Participants will be recruited in selected countries through an online survey. The survey link will be disseminated through local, regional, and national networks. In each country, a lead organization will be responsible for organizing ethical review, translation, and survey administration. The consortium network provides support for national studies, coordination, and multi-national comparison. We will use multi-level modeling to determine the relationship between COVID-19 and condomless sex, gender-based violence, access to reproductive health services, HIV testing, and other key items. This study protocol defines primary outcomes, pre-specified subanalyses, and analysis plans.

    The I-SHARE study examines sexual and reproductive health at the national and global level. We will use multi-level modeling to examine country-level variables associated with outcomes of interest. This will provide a foundation for subsequent online multi-country comparison using more robust sampling methodologies.

    Population: Adults Only
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/I-SHAREProtocol19June2020.pdf
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available
    Associated Survey: https://www.nlm.nih.gov/dr2/I-SHARE_Survey.xlsx
    Link to study website: https://ishare.web.unc.edu

    Available Formats: PDF

    Contact Information:
    Kristien Michielsen
    Ghent University
    Academic Network for Sexual and Reproductive Health and Rights Policy (ANSER)
    Email: kristien.michielsen@ugent.be

    Joseph D. Tucker
    University of North Carolina at Chapel Hill
    London School of Hygiene and Tropical Medicine (LSHTM)
    Email: jdtucker@med.unc.edu
    Includes Research Tools: Yes.
    ID: 23309. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  6. COVID-19: Well-Being and HRQoL in Cancer Patients and Survivors: Protocol
    Source: University of Miami (UM)
    Date Published: 4/29/2020
    Format: PDF
    Annotation: Cross-sectional study protocol. Sociodemographics: Age -- 18 years or older. Gender -- Nonspecific. Race/ethnicity -- Nonspecific; however, the participant needs to be fluent in English or Spanish. Geographical region: Miami, Florida, and Houston, Texas. Targeted population: ICD-10 confirmed cancer diagnosis for cancer patients or survivors who had an oncology visit within the University of Miami Miller School of Medicine (UM/MSOM) Sylvester Comprehensive Cancer Center health system in the past five years. Study links patient demographic and clinical data via the health system’s electronic data warehouse and uses the survey "Impact of the Pandemic and HRQoL in Cancer Patients and Survivors (IPHCPS)" to assess impacts of COVID-19.

    Population: Adults only
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/Impact_of_the_Pandemic_HRQoL_in_Cancer_Patients_and_Survivors.pdf
    Authors: Penedo, Frank; Antoni, Michael
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Associated survey: https://www.nlm.nih.gov/dr2/COVID-19_IMPACT_HRQOL_QUESTIONNAIRE_FINAL.pdf (https://dr2.nlm.nih.gov/search/?q=22130)
    Includes Research Tools: Yes.
    ID: 22131. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  7. Mental Health Impact of COVID-19 Pandemic on NIMH Research Participants and Volunteers Protocol
    Source: National Institute of Mental Health [National Institutes of Health] (NIMH)
    Date Published: 4/20/2020
    Format: PDF
    Annotation: This protocol provides the rationale, background, objectives, design, methodology, statistical considerations, organization for the National Institute of Mental Health Psychosocial Impact of COVID-19 Survey: https://dr2.nlm.nih.gov/search/?q=22587
    Abbreviated title: MINH COVID Study    ...[See more] [See less]
    URL: https://disasterinfo.nlm.nih.gov/content/files/20_M_N085_Research_Protocol.pdf
    Type: Study Design/Protocol
    Access Notes: Contact Information:
    Study team: NIMHResearchVolunteer@nih.gov
    Joyce Chung, MD, National Institute of Mental Health (NIMH) Intramural Research Program, joyce.chung@nih.gov
    Includes Research Tools: Yes.
    ID: 24225. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  8. Impact of COVID-19 on People Living with Rare Disease and their Families: Protocol
    Source: Rare Diseases Clinical Research Network [National Center for Advancing Translational Sciences] (RDCRN)
    Date Published: 4/8/2020
    Format: PDF
    Annotation: This is the protocol for the "Impact of COVID-19 on People Living with Rare Disease and their Families" (https://dr2.nlm.nih.gov/search/?q=22513). The survey is a brief, self-report, online-based questionnaire administered via REDCap (Research Electronic Data Capture system) to:

    1) Estimate the proportion of patients who live with rare diseases who have been diagnosed with COVID-19 infection;
    2) Describe the characteristics of the COVID-19 presentation and the course of the infection (including treatment) among patients with rare diseases;
    3) Determine whether subgroups of patients defined by sociodemographic variables, geographic location, with particular rare conditions or comorbidity have been affected more frequently or have experienced increased severity of the infection;
    4) Learn about potential interaction between specific treatment regimens and COVID-19 infection, and specifically whether certain antibiotic, immunosuppressive, or anti-inflammatory drugs are associated with the frequency of COVID-19 infection and its severity;
    5) Assess the extent to which the COVID-19 pandemic has affected the life of rare disease patients and their families, including their access to medical care and routine medication;
    6) Learn about the main concerns that people who live with rare diseases and their families have with respect to COVID-19, and determine how the RDCRN can respond by providing information and advice through its network of experts, its consortia, and in collaboration with patient advocacy groups; and
    7) Allow follow-up for patients and families who agree to provide contact information, and linkage of information collected in the survey with data maintained by the RDCRN for patients enrolled in RDCRN research studies.

    Population: High Risk/Special/Unique Populations
    Time to Complete: 20 Minutes
    Mode of Administration: Online (e.g., computer-assisted interview)
    Administered by: Self Administered
    Language(s): English    ...[See more] [See less]
    URL: https://www.nlm.nih.gov/dr2/RDCRN_COVID19_Protocol_08Apr2020.pdf
    Type: Study Design/Protocol
    Access Notes: Associated Survey Instrument: https://www.nlm.nih.gov/dr2/RDCRN_COVID-19_Survey_08Apr20204.pdf (https://dr2.nlm.nih.gov/search/?q=22513)

    Free/Publicly Available

    Available Formats: PDF

    Contact Information: Cincinnati Children's Hospital Medical Center, email: rd.covid19@cchmc.org
    Includes Research Tools: Yes.
    ID: 22514. From: Disaster Lit®a database of the U.S. National Library of Medicine.
    REDCap: Yes.
  9. Household Transmission Investigation Protocol for 2019-Novel Coronavirus (COVID-19) Infection
    Source: World Health Organization (WHO)
    Date Published: 2/28/2020
    Format: PDF
    Annotation: This 31-page household transmission investigation is a case-ascertained prospective study of all identified household contacts of a laboratory confirmed 2019-novel coronavirus (2019-nCoV) infection. It is intended to provide rapid and early information on the clinical, epidemiological, and virological characteristics of 2019-nCoV. The protocol has been designed to investigate household transmission of 2019-nCoV in any country in which 2019-nCoV infection has been reported and households are exposed.

    Population: All/Anyone
    Length: 29 items
    Administered by: Specialist/Doctor/Expert
    Language(s): English    ...[See more] [See less]
    URL: https://www.who.int/publications/i/item/household-transmission-investigation-protocol-for-2019-novel-coronavirus-(2019-ncov)-infection
    Type: Study Design/Protocol
    Access Notes: Direct link to document: https://apps.who.int/iris/rest/bitstreams/1272252/retrieve

    Permission/Request required

    Contact Information: EarlyInvestigations-2019-nCoV@who.int, godata@who.int
    Includes Research Tools: Yes.
    ID: 20698. From: Disaster Lit®a database of the U.S. National Library of Medicine.
  10. First Few X (FFX) Cases and Contact Investigation Protocol for 2019-Novel Coronavirus (2019-nCoV) Infection, Version 2
    Source: World Health Organization (WHO)
    Date Published: 2/10/2020
    Format: PDF
    Annotation: This 65-page protocol, updated on February 2, 2020, has been designed to investigate the First Few X (FFX) cases of 2019 novel coronavirus (2019-nCoV) and their close contacts. It is envisioned that the FFX 2019-nCoV investigation will be conducted across several countries or sites with geographical and demographic diversity. Using a standardized protocol such as the protocol provided here, epidemiological exposure data and biological samples can be systematically collected and shared rapidly in a format that can be easily aggregated, tabulated, and analyzed across many different settings globally for timely estimates of 2019-nCoV infection severity and transmissibility, as well as to inform public health responses and policy decisions.

    Population: All/Anyone
    Length: 6 items
    Administered by: Specialist/Doctor/Expert
    Language(s): English    ...[See more] [See less]
    URL: https://www.who.int/docs/default-source/coronaviruse/20200129-generic-ffx-protocol-2019-ncov.pdf?sfvrsn=595eb313_2&download=true
    Type: Study Design/Protocol
    Access Notes: Free/Publicly Available

    Contact Information: godata@who.int, https://www.who.int/godata
    Includes Research Tools: Yes.
    ID: 20719. From: Disaster Lit®a database of the U.S. National Library of Medicine.
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