Comparison of On-Site Versus Remote Mobile Device Support in the Framingham Heart Study Using the Health eHeart Study for Digital Follow-up: Randomized Pilot Study Set Within an Observational Study Design.

BACKGROUND: New electronic cohort (e-Cohort) study designs provide resource-effective methods for collecting participant data. It is unclear if implementing an e-Cohort study without direct, in-person participant contact can achieve successful participation rates. OBJECTIVE: The objective of this study was to compare 2 distinct enrollment methods for setting up mobile health (mHealth) devices and to assess the ongoing adherence to device use in an e-Cohort pilot study. METHODS: We coenrolled participants from the Framingham Heart Study (FHS) into the FHS-Health eHeart (HeH) pilot study, a digital cohort with infrastructure for collecting mHealth data. FHS participants who had an email address and smartphone were randomized to our FHS-HeH pilot study into 1 of 2 study arms: remote versus on-site support. We oversampled older adults (age ≥65 years), with a target of enrolling 20% of our sample as older adults. In the remote arm, participants received an email containing a link to enrollment website and, upon enrollment, were sent 4 smartphone-connectable sensor devices. Participants in the on-site arm were invited to visit an in-person FHS facility and were provided in-person support for enrollment and connecting the devices. Device data were tracked for at least 5 months. RESULTS: Compared with the individuals who declined, individuals who consented to our pilot study (on-site, n=101; remote, n=93) were more likely to be women, highly educated, and younger. In the on-site arm, the connection and initial use of devices was ≥20% higher than the remote arm (mean percent difference was 25% [95% CI 17-35] for activity monitor, 22% [95% CI 12-32] for blood pressure cuff, 20% [95% CI 10-30] for scale, and 43% [95% CI 30-55] for electrocardiogram), with device connection rates in the on-site arm of 99%, 95%, 95%, and 84%. Once connected, continued device use over the 5-month study period was similar between the study arms. CONCLUSIONS: Our pilot study demonstrated that the deployment of mobile devices among middle-aged and older adults in the context of an on-site clinic visit was associated with higher initial rates of device use as compared with offering only remote support. Once connected, the device use was similar in both groups.

Effect of a Game-Based Intervention Designed to Enhance Social Incentives to Increase Physical Activity Among Families: The BE FIT Randomized Clinical Trial.

Importance: Gamification, the application of game design elements such as points and levels in nongame contexts, is often used in digital health interventions, but evidence on its effectiveness is limited. Objective: To test the effectiveness of a gamification intervention designed using insights from behavioral economics to enhance social incentives within families to increase physical activity. Design, Setting, and Participants: The Behavioral Economics Framingham Incentive Trial (BE FIT) was a randomized clinical trial with a 12-week intervention period and a 12-week follow-up period. The investigation was a community-based study between December 7, 2015, and August 14, 2016. Participants in the modified intent-to-treat analysis were adults enrolled in the Framingham Heart Study, a long-standing cohort of families. Interventions: All participants tracked daily step counts using a wearable device or a smartphone, established a baseline, selected a step goal increase, and received daily individual feedback on goal performance by text message or email for 24 weeks. Families in the gamification arm could earn points and progress through levels based on physical activity goal achievement during the 12-week intervention. The game design was meant to enhance collaboration, accountability, and peer support. Main Outcomes and Measures: The primary outcome was the proportion of participant-days that step goals were achieved during the intervention period. Secondary outcomes included the proportion of participant-days that step goals were achieved during the follow-up period and the change in the mean daily steps during the intervention and follow-up periods. Results: Among 200 adults comprising 94 families, the mean age was 55.4 years, and 56.0% (n = 112) were female. During the intervention period, participants in the gamification arm achieved step goals on a significantly greater proportion of participant-days (0.53 vs 0.32; adjusted difference, 0.27; 95% CI, 0.20-0.33; P < .001) and had a significantly greater increase in the mean daily steps compared with baseline (1661 vs 636; adjusted difference, 953; 95% CI, 505-1401; P < .001) than the control arm. During the follow-up period, physical activity in the gamification arm declined but remained significantly greater than that in the control arm for the proportion of participant-days achieving step goals (0.44 vs 0.33; adjusted difference, 0.12; 95% CI, 0.05-0.19; P < .001) and the mean daily steps compared with baseline (1385 vs 798; adjusted difference, 494; 95% CI, 170-818; P < .01). Conclusions and Relevance: Gamification designed to leverage insights from behavioral economics to enhance social incentives significantly increased physical activity among families in the community. Trial Registration: clinicaltrials.gov Identifier: NCT02531763.

Digital Connectedness in the Framingham Heart Study.

BACKGROUND: New avenues of data collection such as eHealth and mobile technology have the potential to revolutionize the way large populations can be assessed and managed outside of standard research and clinical settings. METHODS AND RESULTS: A digital connectedness survey was administered within the Framingham Heart Study from 2014 to 2015. The exposure was usage of the Internet, email, cell phones, and smartphones in relation to demographic and cardiovascular disease risk factors; all results were adjusted for age and sex. Among 8096 living study participants, 6503 (80.3%) completed the digital survey. Among survey responders, 5678 (87.4%) reported regular Internet use. Participants reporting regular Internet use were younger (aged 59.1 versus 76.5 years, P<0.0001), were more likely to be employed (70.3% versus 23.7%, P=0.002), and had more favorable cardiovascular disease risk factors than those who did not use the Internet (all P≤0.05). Overall, 5946 (92.1%) responders reported using cell phones. Among cell phone users, 3907 (67.8%) had smartphones. Smartphone users were younger (aged 55.4 versus 68.5 years, P<0.0001), more likely to be employed (81.1% versus 43.9%, P<0.0001) and to have a college education, and less likely to have hypertension (27.9% versus 55.7%, P=0.0002) than those who did not use smartphones. CONCLUSIONS: Digital connectedness varies substantially by age; connected persons tend to be younger and better educated and to have more favorable cardiovascular disease risk factor profiles. Less than two-thirds of study participants who completed the survey had a smartphone. The generalizability of studies focused on digitally connected persons may have limitations.

Consent for genetic research in the Framingham Heart Study.

Extensive efforts have been aimed at understanding the genetic underpinnings of complex diseases that affect humans. Numerous genome-wide association studies have assessed the association of genes with human disease, including the Framingham Heart Study (FHS), which genotyped 550,000 SNPs in 9,000 participants. The success of such efforts requires high rates of consent by participants, which is dependent on ethical oversight, communications, and trust between research participants and investigators. To study this we calculated percentages of participants who consented to collection of DNA and to various uses of their genetic information in two FHS cohorts between 2002 and 2009. The data included rates of consent for providing a DNA sample, creating an immortalized cell line, conducting research on various genetic conditions including those that might be considered sensitive, and for notifying participants of clinically significant genetic findings were above 95%. Only with regard to granting permission to share DNA or genetic findings with for-profit companies was the consent rate below 95%. We concluded that the FHS has maintained high rates of retention and consent for genetic research that has provided the scientific freedom to establish collaborations and address a broad range of research questions. We speculate that our high rates of consent have been achieved by establishing frequent and open communications with participants that highlight extensive oversight procedures. Our approach to maintaining high consent rates via ethical oversight of genetic research and communication with study participants is summarized in this report and should be of help to other studies engaged in similar types of research. Published 2010 Wiley-Liss, Inc.