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Study Information

dbGaP Study Accession: phs002964

NIH Institute/Center: NIDCD

RADx Data Program: RADx-rad

DOI: 10.60773/xb7r-qw92

Release Date: 08/30/2024

Study Description: Self-report of sudden loss of smell or taste substantially increases the odds of being infected with SARS-CoV-2. However, self-report of smell function is an unreliable predictor of smell loss. The study created a self-administered easy to use "at home" 5-minute objective smell test to uncover alterations in smell function unbeknownst to many individuals and confer increased risk of infection by SARS- CoV-2. The new smell test consists of a physical smell card containing peel and sniff odor labels and a web- based application. Each participant accessed the web-based app on their own smartphone, tablet, or computer. The study developed a native app to conduct longitudinal COVID Smell Test (Aim 1), collect data on asymptomatic health care workers, symptomatic patients, and undergraduates (Aim 2) and develop algorithms for the longitudinal smell test for personalized thresholds, differentiate smell loss from COVID relative to influenza (Aim 3). The Longitudinal COVID Smell Test was accessible, affordable, and readily scalable. Effective screening with the COVID smell test better informed students and employees if they should not report to school or work and seek an evaluation by a healthcare professional.

Updated Date: 01/18/2024

Principal Investigator: Albers, Mark

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Diagnostic Testing; Digital Health Applications; Influenza

Data Collection Method: Chemosensory Testing Device

Keywords: Anosmia; Ansomic Patients; Healthcare Workers; Odor Discrimination; Odor Identification; Odor Intensity; Olfaction; Olfactory Function; Olfactory Testing; Smell Function; Smell Test; Symptomatic Population

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

Study Sites: University of Maryland

Data Types: Clinical; Electronic Medical Records; Questionnaire or Survey

Study Start Date: 12/21/2020

Study End Date: 05/31/2023

Species: Human

Estimated Cohort Size: 6000

Study Population Focus: Adults; Essential Workers; Older Adults or Elderly

Study Website URL: https://rally.massgeneralbrigham.org/study/at_home_covidsmell_test_

ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05040659

Acknowledgement Statement: This study was supported through funding, 4U01DC019579-03, for the National Institute on Deafness and Other Communication Disorders (NIDCD) as part of the RADx-rad program. This work was supported by Principal Investigator Dr. Mark Albers. A special acknowledgment to our Collaborating site, University of Maryland, our study team, research staff, and the study participants that made this project possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002964.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: RFA-OD-20-022

NIH Grant or Contract Number(s): 4U01DC019579-03

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 112
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_education_yrsHow many years of education have you completed?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_deafAre you deaf or do you have serious difficulty hearing?
nih_blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
nih_memoryBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
nih_walk_climbDo you have serious difficulty walking or climbing stairs?
nih_dress_batheDo you have difficulty dressing or bathing?
nih_errandBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
nih_vaping_ynVaping use (Yes or No)
nih_nicotine_ynNicotine use (Yes or No)
nih_alcohol_ynAlcohol use (Yes or No)
nih_asthmaAsthma
nih_cancerCancer
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_lung_diseaseChronic lung disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_immunosuppressive_conditionImmunosuppressive condition
nih_serious_mental_illnessSerious mental illness
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_conjunctivitisConjunctivitis
nih_health_statusWould you say that (your) health in general is excellent, very good, good, fair, or poor?
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
abdominal_painAbdominal pain
ageWhat is your age? (Age in years. For babies less than 1 year old, write 0 as the age)
alcohol_useAlcohol Use
asthmaAsthma
blindAre you blind or do you have serious difficulty seeing, even when wearing glasses?
cancerCancer
cardiovascular_diseaseCardiovascular disease
chillsChills
chronic_kidney_diseaseChronic kidney disease
chronic_lung_diseaseChronic lung disease
conjunctivitisConjunctivitis
coughCough
deafAre you deaf or do you have serious difficulty hearing?
diabetesDiabetes
diarrheaDiarrhea
dress_bathe_disDo you have difficulty dressing or bathing?
educationHow many years of education have you completed? (Years of education from 0 - 20+)
employmentAre you employed?
errand_disBecause of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor's office or shopping?
ethnicityAre you of Hispanic or Latino origin?
excessive_fatigueExcessive fatigue
feverFever
headacheHeadache
health_statusWould you say that (your) health in general is excellent, very good, good, fair or poor?
height_feetHeight Feet
height_inchesHeight Inches
hypertensionHypertension
immunosuppressive_conditioImmunosuppressive condition
insuranceWhat kind of health insurance do you have?
memory_disBecause of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?
muscle_acheMuscle ache
nausea_vomitingNausea/vomiting
new_loss_of_taste_or_smellNew loss of taste or smell
nicotineNicotine Use
pregnancy_statusPregnancy status
raceWhat is your race? Mark one or more boxes.
serious_mental_illnessSerious mental illness
sexWhat is your biological sex assigned at birth?
shortness_of_breath_or_difShortness of breath or difficulty breathing
sickle_cell_diseaseSickle cell disease
skin_rashSkin rash
vapingVaping Use
walking_climbing_disDo you have serious difficulty walking or climbing stairs?
weight_lbsWhat is your weight? (Weight in pounds)
zipZip or Postal Code: (De-Identified zip code)
assay_readout-
assay_readout_description-
cohort_id-
covid_diagnosis-
covid_test_result-
covid_test_specimen_collector-
covid_test_specimen_type-
covid_test_specimen_type_other-
covid_test_type-
covid_vaccine_doses-
date_enrolled-
days_since_most_recent_vaccine-
days_since_patient_covid_positive-
measurement_type-
odorant-
odorant_test_max-
odorant_test_min-
protocol_id-
signal_detection-
study_id-
symptom_onset_days-
technology_description-
technology_platform-
timepoint-
Data Files
Total Files: 15
Data Files: 5
Metadata Files: 5
Dictionary Files: 5
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
rad_022_579-01_longitudinal_smell_test_clincial_test_results_DATA_transformcopy.csvTabular Data - Harmonizedcsv540
rad_022_579-01_longitudinal_smell_test_clinical_samples_DATA_origcopy.csvTabular Data - Non-harmonizedcsv174
rad_022_579-01_aromha_technology_description_DATA_origcopy.csvTabular Data - Non-harmonizedcsv18
rad_022_579-01_longitudinal_smell_test_clincial_test_results_DATA_origcopy.csvTabular Data - Non-harmonizedcsv540
rad_022_579-01_longitudinal_smell_test_clinical_samples_DATA_transformcopy.csvTabular Data - Harmonizedcsv174