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 Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education | What is the highest level of education you have achieved outside or in the United States? |
nih_zip | What is your zip code? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_disability | Do you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities? |
nih_deaf | Are you deaf or do you have serious difficulty hearing? |
nih_blind | Are you blind or do you have serious difficulty seeing, even when wearing glasses? |
nih_memory | Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions? |
nih_walk_climb | Do you have serious difficulty walking or climbing stairs? |
nih_dress_bathe | Do you have difficulty dressing or bathing? |
nih_errand | Because 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_freq | Vaping Frequency: Do you now use electronic cigarettes every day, some days, rarely, or not at all? |
nih_cig_smoke_freq | Nicotine Frequency: Do you now smoke cigarettes? |
nih_smoking_yn | Do you use any tobacco/nicotine products (including cigarettes, cigars, e-cigarettes, etc)? |
nih_alcohol_yrs | How often did you have a drink containing alcohol in the past year? |
nih_asthma | Asthma |
nih_cancer | Cancer |
nih_cancer_active_treatment | Cancer (including leukemia or lymphoma) undergoing active treatment? |
nih_cardiovascular_disease | Cardiovascular disease |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_chronic_kidney_disease_treatment | Chronic kidney disease treatment |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_mental_health_disorder | Mental health disorder |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_immunocompromised | Immunocompromised condition |
nih_chronic_lung | Other chronic lung disease |
nih_depression | Depression |
nih_alc_sub_abuse | Alcohol or substance use disorder |
nih_iv_drug_use | Intravenous drug use |
nih_othermh | Other mental health disorder |
nih_coronary_artery_disease_angina | Coronary artery disease (blockages in your heart vessels) or angina (chest pain)? |
nih_heart_attack | A heart attack (myocardial infarction)? |
nih_chf | Congestive Heart failure (CHF, Heart Failure)? |
nih_stroke | Stroke or TIA (Transient Ischemic Attack or Mini-Stroke)? |
nih_immunodeficiency | Immunodeficiency (NOT including HIV)? |
nih_hiv | Chronic HIV infection? |
nih_anemia | Anemia or other blood disorder (do not include leukemia or lymphoma)? |
nih_premature_birth | History of premature birth (being born before 37 weeks of pregnancy) |
nih_chd | Chronic Heart Disease |
nih_cf | Cystic Fibrosis |
nih_cld_bpd | CLD BPD (Chronic Lung Disease Bronchopulmonary Dysplasia) |
nih_copd_plus | Chronic obstructive pulmonary disease (COPD) including emphysema, chronic bronchitis, obstructive pulmonary disease? |
nih_no_chronic_condition | No chronic condition |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_red_eyes | Red or painful eyes |
nih_high_temp | A temperature greater than 100.4 °F |
nih_other_symp | Other |
nih_no_sympt | None of the above |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
nih_height_category | Approximately what is your height? |
nih_weight_category | Approximately what is your weight? |
race_asian | Asian |
race_black | Black |
race_dk | Don't know |
race_white | White |
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 | - |