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Study Information

dbGaP Study Accession: phs002739

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

DOI: 10.60773/v1k1-md20

Release Date: 09/01/2022

Study Description: The purpose of this feasibility study was to gather knowledge that will inform a future larger study using at-home SARS-CoV-2 testing and digital tools. This study will: 1) Test the feasibility of daily home SARS-CoV-2 testing using the Quidel QuickVue® device; 2) Test whether a smartphone app (CareEvolution MyDataHelps™) designed to support at-home testing is acceptable and usable; and 3) Examine other key process metrics and variables important to the design of a larger randomized trial. In particular, the feasibility of the Quidel QuickVue® home test and the digital app will be assessed through data on the number of home SARS-CoV-2 tests performed and number of home SARS-CoV-2 tests transmitted through the mobile health app. Secondary outcomes of importance are: (1) participant self-reported overall usability of the app-supported at-home testing system; (2) participant self-reported acceptability of the at-home test and smartphone app using the net promoter scale; (3) participant self-reported quality of the CareEvolution MyDataHelps™ app using uMARS (Mobile app rating scale); and (4) concordance between self-interpretation and study-team interpretation of self-test SARS-CoV-2 results. This was a feasibility study that enrolled an observational cohort into an intervention-only arm of future cluster RCT.

Updated Date: 04/09/2024

Principal Investigator: Gibson, Laura

Has Data Files: Yes

Study Domain: At-Home or Over-the-Counter (OTC) Self-Testing; Digital Health Applications; Medical Device or Tool Development; Rapid Diagnostic Test (RDT); Virological Testing

Data Collection Method: Antigen Testing Device; Smartphone

Keywords: Feasibility; mHealth

Study Design: Longitudinal Cohort

Multi-Center Study: Yes

Study Sites: University of Massachusetts Chan Medical School and Northwestern University

Data Types: Behavioral; Questionnaire or Survey

Study Start Date: 02/01/2021

Study End Date: 02/20/2021

Species: Human

Estimated Cohort Size: 206

Study Population Focus: Adults; Older Adults or Elderly

Acknowledgement Statement: This study was supported through funding, 5U54HL143541-04, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx Tech program. Operations support and data management occurred primarily through the UMass Chan Medical School’s Center for Clinical and Translational Science, Clinical Studies Core, and the Department of Population and Quantitative Health Sciences. Additional recruitment of participants occurred at Northwestern University. Data collection occurred through the MyDataHelps Platform managed by the CareEvolution team. Quest Diagnostics ran the standard comparators (Roche 6800 Cobas PCR for SARS-CoV-2 assays). Approved users should acknowledge the provision of data access by dbGaP for accession phs002739.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: PAR-17-453

NIH Grant or Contract Number(s): 5U54HL143541-04

Consent/Data Use Limitations: General Research Use

Variable Information
Total Variables: 322
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_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
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_vape_freqVaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all?
nih_cig_smoke_freqNicotine Frequency: Do you now smoke cigarettes?
nih_smoking_ynDo you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)?
nih_alcohol_yrsHow often did you have a drink containing alcohol in the past year?
nih_asthmaAsthma
nih_cancerCancer
nih_cancer_active_treatmentCancer (including leukemia or lymphoma) undergoing active treatment?
nih_cardiovascular_diseaseCardiovascular disease
nih_chronic_kidney_diseaseChronic kidney disease
nih_chronic_kidney_disease_treatmentChronic kidney disease treatment
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_immunocompromisedImmunocompromised condition
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_othermhOther mental health disorder
nih_coronary_artery_disease_anginaCoronary artery disease (blockages in your heart vessels) or angina (chest pain)?
nih_heart_attackA heart attack (myocardial infarction)?
nih_chfCongestive Heart failure (CHF, Heart Failure)?
nih_strokeStroke or TIA (Transient Ischemic Attack or Mini-Stroke)?
nih_immunodeficiencyImmunodeficiency (NOT including HIV)?
nih_hivChronic HIV infection?
nih_anemiaAnemia or other blood disorder (do not include leukemia or lymphoma)?
nih_premature_birthHistory of premature birth (being born before 37 weeks of pregnancy)
nih_chdChronic Heart Disease
nih_cfCystic Fibrosis
nih_cld_bpdCLD BPD (Chronic Lung Disease Bronchopulmonary Dysplasia)
nih_copd_plusChronic obstructive pulmonary disease (COPD) including emphysema, chronic bronchitis, obstructive pulmonary disease?
nih_no_chronic_conditionNo chronic condition
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_throat_congestion_noseSore throat, congestion or runny nose
nih_red_eyesRed or painful eyes
nih_high_tempA temperature greater than 100.4 °F
nih_other_sympOther
nih_no_symptNone of the above
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
nih_height_categoryApproximately what is your height?
nih_weight_categoryApproximately what is your weight?
race_asianAsian
race_blackBlack
race_dkDon't know
race_whiteWhite
age-
AlcoholUse-
CigarrettesPerDay-
CloseContact-
CloseContactDays-
ColorBlind-
cond_alcohol_subs-
cond_asthma-
cond_cancer-
cond_chronic_lung_disease-
cond_ckd-
cond_copd-
cond_cvd-
cond_depression-
cond_diabetes-
cond_hypertension-
cond_immun_compromised-
cond_iv_drug-
cond_mental_health-
cond_none-
cond_other-
cond_other_other-
ContactDuration-
ContactHousehold-
CurrentConditionsOther-
CurrentCovid-
DataReport-
EcigUse-
EducationGrade-
EducationLevel-
Eligibility-
EmploymentStatus-
EmploymentStatusOther-
EmploymentStatusStudent-
EnrollmentDt-
EUAResultDate-
EUAResultDate_1-
EUAResultDate_2-
EUAResultDate_3-
EUAResultDate_4-
EUATestDate-
EUATestDate_1-
EUATestDate_2-
EUATestDate_3-
EUATestDate_4-
EUATestResult-
EUATestResult_1-
EUATestResult_2-
EUATestResult_3-
EUATestResult_4-
FurtherInfoProvided-
gender_man-
gender_noans-
gender_nonbin-
gender_trans-
gender_woman-
HealthInsurance-
height_cm-
HispanicOrigin-
Housing-
HousingOther-
InPersonDelivery-
is_18-
LimitDailyActivity-
LongForm-
MasklessContactDuration-
NasalSwab1-
NasalSwab2-
NicotineUse-
nih_chronic_kidney_disease_trt-
nih_coronary_artery_dis_angina-
NoFurtherInfoProvidedRation-
OverallHealth-
ParticipantIdentifier-
PCRKnowledge-
PictureIntro-
Pregnant-
PriorInfection-
PriorInfectionTimeframe-
quest_assay-
quest_ct1-
quest_ct2-
quest_ct_orig-
quest_dos-
quest_result-
quest_target1-
quest_target2-
race_asian_asian-
race_asian_chinese-
race_asian_filipino-
race_asian_indian-
race_asian_other-
race_asian_vietnamese-
race_nativeam-
race_noans-
race_oth-
reasonsforcontact_appissues-
reasonsforcontact_interpret-
reasonsforcontact_other-
reasonsforcontact_positivetest-
reasonsforcontact_symptom_rep-
reasonsforcontact_test_issues-
research_test-
ResultCommunicationDate-
se_attended_school_1-
se_attended_school_2-
se_attended_school_3-
se_attended_sleepover_1-
se_attended_sleepover_2-
se_attended_sleepover_3-
se_bars_1-
se_bars_2-
se_bars_3-
se_buffets_1-
se_buffets_2-
se_buffets_3-
se_casinos_1-
se_casinos_2-
se_casinos_3-
se_christmas_caroling_1-
se_christmas_caroling_2-
se_christmas_caroling_3-
se_church_1-
se_church_2-
se_church_3-
se_curbside_or_takeout_food_1-
se_curbside_or_takeout_food_2-
se_curbside_or_takeout_food_3-
se_date_1-
se_date_2-
se_date_3-
se_dined_at_a_rest_outdoor_1-
se_dined_at_a_rest_outdoor_2-
se_dined_at_a_rest_outdoor_3-
se_doctor_appointment_1-
se_doctor_appointment_2-
se_doctor_appointment_3-
se_driving_through_mult_states_1-
se_driving_through_mult_states_2-
se_driving_through_mult_states_3-
se_engagement_none_1-
se_engagement_none_2-
se_engagement_none_3-
se_family_reunion_1-
se_family_reunion_2-
se_family_reunion_3-
se_grocery_delivery_1-
se_grocery_delivery_2-
se_grocery_delivery_3-
se_hire_a_house_cleaner_1-
se_hire_a_house_cleaner_2-
se_hire_a_house_cleaner_3-
se_home_exercise_1-
se_home_exercise_2-
se_home_exercise_3-
se_ice_skated_indoors_1-
se_ice_skated_indoors_2-
se_ice_skated_indoors_3-
se_ice_skating_outdoors_1-
se_ice_skating_outdoors_2-
se_ice_skating_outdoors_3-
se_indoor_gym_1-
se_indoor_gym_2-
se_indoor_gym_3-
se_indoor_restaurant_1-
se_indoor_restaurant_2-
se_indoor_restaurant_3-
se_instore_getting_groceries_1-
se_instore_getting_groceries_2-
se_instore_getting_groceries_3-
SelfInterpret-
se_movie_theaters_1-
se_movie_theaters_2-
se_movie_theaters_3-
se_multihh_celebration_1-
se_multihh_celebration_2-
se_multihh_celebration_3-
se_played_basketball_indoors_1-
se_played_basketball_indoors_2-
se_played_basketball_indoors_3-
se_sat_in_an_airplane_1-
se_sat_in_an_airplane_2-
se_sat_in_an_airplane_3-
se_sledding_1-
se_sledding_2-
se_sledding_3-
se_spending_time_hh_members_1-
se_spending_time_hh_members_2-
se_spending_time_hh_members_3-
se_stayed_in_a_hotel_1-
se_stayed_in_a_hotel_2-
se_stayed_in_a_hotel_3-
se_used_public_restroom_1-
se_used_public_restroom_2-
se_used_public_restroom_3-
se_used_public_transit_1-
se_used_public_transit_2-
se_used_public_transit_3-
se_video_chats_1-
se_video_chats_2-
se_video_chats_3-
se_visited_hair_salon_barber_1-
se_visited_hair_salon_barber_2-
se_visited_hair_salon_barber_3-
se_visited_indoor_malls_1-
se_visited_indoor_malls_2-
se_visited_indoor_malls_3-
se_visited_outlet_malls_1-
se_visited_outlet_malls_2-
se_visited_outlet_malls_3-
se_walks_with_strangers_1-
se_walks_with_strangers_2-
se_walks_with_strangers_3-
se_went_to_an_office_1-
se_went_to_an_office_2-
se_went_to_an_office_3-
se_working_from_home_1-
se_working_from_home_2-
se_working_from_home_3-
Sex-
smp_abd_pain-
smp_body_aches-
smp_cough-
smp_fatigue-
smp_fever-
smp_headache-
smp_loss_smell-
smp_nausea-
smp_none-
smp_other-
smp_rash-
smp_runny_nose-
smp_sob-
startdt-
target1_result-
target2_result-
TestStripImageExpertRead_res-
TestStripImagePartRead_res-
TravelPCR-
Vaccine-
VaccineRecord-
VaccineRecordCompany-
VaccineRecordDose1Date-
VaccineRecordDose2Date-
VaccineRecordDoses-
VisionDifficulty-
weight_kg-
Withdraw_NoContact-
Zip-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
Study Documentationphs002739_Participant Questionnaires_v2_07APR2021.pdf827.07 KB
Study Documentationphs002739_Protocol_15SEP2021.pdf610.42 KB
Data Files
Total Files: 7
Data Files: 5
Metadata Files: 0
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
phs002739_transformcopy_2024-04-09.csvTabular Data - Harmonizedcsv205

phs002739_tier2_3_2024-04-09.csvTabular Data - Non-harmonizedcsv2970

phs002739_origincopy_2024-04-09.csvTabular Data - Non-harmonizedcsv205

phs002739_2022-09-01_DATA_transformcopy.csvTabular Data - Harmonizedcsv206

phs002739_2022-09-01_DATA_origcopy.csvTabular Data - Non-harmonizedcsv206