dbGaP Study Accession: phs002739

NIH Institute/Center: NHLBI

RADx Data Program: RADx Tech

Release Date: 09/01/2022

DOI: 10.60773/v1k1-md20

Updated Date: 04/09/2024

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.

Principal Investigator: Gibson, Laura

Has Data Files: Yes

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

Data Collection Method: Antigen Testing Device; Smartphone

Keywords: mHealth; Feasibility

Study Design: Longitudinal Cohort

Multi-Center Study: TRUE

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

Data Types: Behavioral; Questionnaires/Surveys

Study Start Date: 02/01/2021

Study End Date: 02/20/2021

Species: Human Data

Estimated Cohort Size: 206

Study Population Focus: Older Adults or Elderly; Adults

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