Background eCohort studies offer an efficient approach for data collection. However, eCohort studies are challenged by volunteer bias and low adherence. We designed an eCohort embedded in the Framingham Heart Study (eFHS) to address these challenges and to compare the digital data to traditional data collection. Objective The aim of this study was to evaluate adherence of the eFHS app-based surveys deployed at baseline (time of enrollment in the eCohort) and every 3 months up to 1 year, and to compare baseline digital surveys with surveys collected at the research center. Methods We defined adherence rates as the proportion of participants who completed at least one survey at a given 3-month period and computed adherence rates for each 3-month period. To evaluate agreement, we compared several baseline measures obtained in the eFHS app survey to those obtained at the in-person research center exam using the concordance correlation coefficient (CCC). Results Among the 1948 eFHS participants (mean age 53, SD 9 years; 57% women), we found high adherence to baseline surveys (89%) and a decrease in adherence over time (58% at 3 months, 52% at 6 months, 41% at 9 months, and 40% at 12 months). eFHS participants who returned surveys were more likely to be women (adjusted odds ratio [aOR] 1.58, 95% CI 1.18-2.11) and less likely to be smokers (aOR 0.53, 95% CI 0.32-0.90). Compared to in-person exam data, we observed moderate agreement for baseline app-based surveys of the Physical Activity Index (mean difference 2.27, CCC=0.56), and high agreement for average drinks per week (mean difference 0.54, CCC=0.82) and depressive symptoms scores (mean difference 0.03, CCC=0.77). Conclusions We observed that eFHS participants had a high survey return at baseline and each 3-month survey period over the 12 months of follow up. We observed moderate to high agreement between digital and research center measures for several types of surveys, including physical activity, depressive symptoms, and alcohol use. Thus, this digital data collection mechanism is a promising tool to collect data related to cardiovascular disease and its risk factors.
Background: Over-the-counter rapid antigen tests for SARS-CoV-2 with an Emergency Use Authorization (EUA) in the United States generally include a condition of authorization to evaluate the test's performance in asymptomatic individuals when used serially. A goal of this study was to investigate the performance of SARS-CoV-2 antigen serial testing and generate data to support regulatory decisions. Objective: To describe a novel study design to evaluate serial use of rapid antigen tests in detecting SARS-CoV-2 virus among asymptomatic individuals. Design: Prospective cohort study using a decentralized approach. Eligible participants from across the U.S. could enroll and complete this study from their home environment through a study app. Participant enrollment was prioritized based on regional 7-day case rates, participants' vaccination status, and sociodemographic characteristics prior to enrollment. Prioritization criteria were adjusted on a daily or weekly basis. Enrolled participants were mailed rapid antigen tests and molecular comparator collection kits and asked to test every 48 hours for 15 days. Three companies' rapid antigen tests were used in the study; assignment of participant to a test was criteria-based and non-random, precluding head-to-head comparison between the tests. Participants: Mainland United States residents over 2 years old with no reported COVID-19 symptoms in the 14 days prior to study enrollment. Main Measures: Participant demographics, COVID-19 vaccination status, and geographic distribution were used to understand the impact of the site-less recruitment and enrollment strategy. Key Results: A total of 7,361 participants enrolled in the study between October 18, 2021 and February 15, 2022. Throughout the study, 369 participants tested positive for SARS-CoV-2, including 167 who were asymptomatic and tested negative on SARS-CoV-2 molecular assays to start the study. This exceeded the initial enrollment goals of 60 positive participants. We enrolled participants from 44 of the 48 mainland U.S. states, and geographic distribution of participants shifted in accordance with the changing COVID-19 prevalence nationwide. Conclusions: The novel, digital site-less approach employed in the 'Test Us At Home' study enabled rapid, efficient, and rigorous evaluation of rapid diagnostics for COVID-19, and can be adapted across research disciplines to optimize study enrollment and accessibility.
BACKGROUND The electronic Framingham Heart Study (eFHS) is an ongoing nested study, which includes FHS study participants, examining associations between health data from mobile devices with cardiovascular risk factors and disease.OBJECTIVE To describe application (app) design, report user characteristics, and describe usability and survey response rates.METHODS Eligible FHS participants were consented and offered a smartwatch (Apple Watch), a digital blood pressure (BP) cuff, and the eFHS smartphone app for administering surveys remotely. We assessed usability of the new app using 2 domains (functionality, aesthetics) of the Mobile App Rating Scale (MARS) and assessed survey completion rates at baseline and 3 months.RESULTS A total of 196 participants were recruited using the enhanced eFHS app. Of these, 97 (49.5%) completed the MARS instrument. Average age of participants was 53 6 9 years, 51.5% were women, and 93.8% were white. Eighty-six percent of participants completed at least 1 measure on the baseline survey, and 50% completed the 3-month assessment. Overall subjective score of the app was 4.2 6 0.7 on a scale from 1 to 5 stars. Of those who shared their health data with others, 46% shared their BP and 7.7% shared their physical activity with a health care provider.CONCLUSION Participants rated the new, enhanced eFHS app positively overall. Mobile app survey completion rates were high, consistent with positive in-app ratings from participants. These mobile data collection modalities offer clinicians new opportunities to engage in conversations about health behaviors.
Long-term use of digital devices is critical for successful clinical or research use, but digital health studies are challenged by a rapid drop-off in participation. A nested e-cohort (eFHS) is embedded in the Framingham Heart Study and uses three system components: a new smartphone app, a digital blood pressure (BP) cuff, and a smartwatch. This study aims to identify factors associated with the use of individual eFHS system components over 1-year. Among 1948 eFHS enrollees, we examine participants who returned surveys within 90 days (n = 1918), and those who chose to use the smartwatch (n = 1243) and BP cuff (n = 1115). For each component, we investigate the same set of candidate predictors for usage and use generalized linear mixed models to select predictors (P < 0.1, P value from Z test statistic), adjusting for age, sex, and time (app use: 3-month period, device use: weekly). A multivariable model with the predictors selected from initial testing is used to identify factors associated with use of components (P < 0.05, P value from Z test statistic) adjusting for age, sex, and time. In multivariable models, older age is associated with higher use of all system components. Female sex and higher education levels are associated with higher completion of app-based surveys whereas higher scores for depressive symptoms, and lower than excellent self-rated health are associated with lower use of the smartwatch over the 12-month follow-up. Our findings show that sociodemographic and health related factors are significantly associated with long-term use of digital devices. Future research is needed to test interventional strategies focusing on these factors to evaluate improvement in long-term engagement.
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