Dataset Information

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial.

ABSTRACT:

Objectives

The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means.

Methods

Candidate participants at possibly higher risk for atrial fibrillation were identified by means of a large insurance claims database and invited to participate in the study by their insurance provider. Enrolled participants were randomly assigned to one of two groups testing a wearable sensor device for detection of the arrhythmia.

Results

Over 10 months, the various outreach methods used resulted in enrollment of 2659 participants meeting eligibility criteria. Starting with a baseline enrollment rate of 0.8% in response to an email invitation, the recruitment campaign was iteratively optimized to ultimately include website changes and the use of a five-step outreach process (three short, personalized emails and two direct mailers) that highlighted the appeal of new technology used in the study, resulting in an enrollment rate of 9.4%. Messaging that highlighted access to new technology outperformed both appeals to altruism and appeals that highlighted accessing personal health information.

Conclusions

Targeted outreach, enrollment, and management of large remote clinical trials is feasible and can be improved with an iterative approach, although more work is needed to learn how to best recruit and retain potential research participants.

Trial registration

Clinicaltrials.govNCT02506244. Registered 23 July 2015.

SUBMITTER: Baca-Motes K

PROVIDER: S-EPMC6329362 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Publications

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial.

Baca-Motes Katie K Edwards Alison M AM Waalen Jill J Edmonds Shawn S Mehta Rajesh R RR Ariniello Lauren L Ebner Gail S GS Talantov Dimitri D Fastenau John M JM Carter Chureen T CT Sarich Troy C TC Felicione Elise E Topol Eric J EJ Steinhubl Steven R SR

Contemporary clinical trials communications 20190107

<h4>Objectives</h4>The advent of large databases, wearable technology, and novel communications methods has the potential to expand the pool of candidate research participants and offer them the flexibility and convenience of participating in remote research. However, reports of their effectiveness are sparse. We assessed the use of various forms of outreach within a nationwide randomized clinical trial being conducted entirely by remote means.<h4>Methods</h4>Candidate participants at possibly h ...[more]

PMID: 30656241

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Project description:BackgroundDiabetes is an independent risk factor for atrial fibrillation (AF), which is associated with increases in mortality and morbidity, as well as a diminished quality of life. Renal involvement in diabetes is common, and since chronic kidney disease (CKD) shares several of the same putative mechanisms as AF, it may contribute to its increased risk in individuals with diabetes. The objective of this study is to identify the relationship between CKD and the rates of newly-diagnosed AF in individuals with diabetes taking part in a screening program using a self-applied wearable electrocardiogram (ECG) patch.Materials and methodsThe study included 608 individuals with a diagnosis of diabetes among 1738 total actively monitored participants in the prospective mHealth Screening to Prevent Strokes (mSToPS) trial. Participants, without a prior diagnosis of AF, wore an ECG patch for 2 weeks, twice, over a 4-months period and followed clinically through claims data for 1 year. Definitions of CKD included ICD-9 or ICD-10 chronic renal failure diagnostic codes, and the Health Profile Database algorithm. Individuals requiring dialysis were excluded from trial enrollment.ResultsNinety-six (15.8%) of study participants with diabetes also had a diagnosis of CKD. Over 12 months of follow-up, 19 new cases of AF were detected among the 608 participants. AF was newly diagnosed in 7.3% of participants with CKD and 2.3% in those without (P < 0.05) over 12 months of follow-up. In a univariate Cox proportional hazard regression analysis, the risk of incident AF was 3 times higher in individuals with CKD relative to those without CKD: hazard ratios (HR) 3.106 (95% CI 1.2-7.9). After adjusting for the effect of age, sex, and hypertension, the risk of incident AF was still significantly higher in those with CKD: HR 2.886 (95% CI 1.1-7.5).ConclusionAmong individuals with diabetes, CKD significantly increases the risk of incident AF. Identification of AF prior to clinical symptoms through active ECG screening could help to improve the clinical outcomes in individuals with CKD and diabetes.

Project description:BackgroundAtrial fibrillation (AF) prevalence estimates vary and have been based on cohorts with clinically established or diagnosed disease. Undiagnosed AF prevalence estimates are less certain as they are based on nongeneralizable convenience samples.HypothesisBecause AF is often asymptomatic, it my remain undiagnosed until the development of complications such as stroke or heart failure. Consequently, the observed prevalence of diagnosed AF from the literature may underestimate total disease burden. We therefore sought to estimate the total prevalence of both diagnosed and undiagnosed AF.MethodsWe performed a retrospective cohort study from 2012 to 2017 using data from five US medical claims data sets. Undiagnosed AF prevalence was estimated based on the observed incidence of ischemic stroke, systemic embolism (SE), and AF incidence after a stroke/SE. The diagnosed AF cohort included AF patients between Q1 2014 and Q3 2015. The undiagnosed AF cohort were patients with assumed undiagnosed AF in the year before a stroke/SE and who were newly diagnosed with AF in the 3-month poststroke/SE. Stroke/SE incidence was calculated among all AF patients and the ratio of number of undiagnosed AF patients to stroke rate was created. Age- and sex-adjusted estimates were stratified by period of assumed undiagnosed AF before poststroke/SE AF diagnosis (1 or 2 years).ResultsThe estimated US prevalence of AF (diagnosed and undiagnosed) in Q3 2015 was 5 628 000 cases, of which 591 000 cases (11%) were undiagnosed. The assumed 2-year undiagnosed AF prevalence was 23% (1 531 000) of the total prevalent patients with AF (6 568 000). Undiagnosed (vs. diagnosed) AF patients were older and had higher CHA2DS2-VASc scores. Of undiagnosed AF, 93% had CHA2DS2-VASc ≥2 and met OAC criteria.ConclusionsThese contemporary estimates demonstrate the high prevalence of undiagnosed AF in the United States. Undiagnosed AF patients are composed of primarily elderly individuals who if diagnosed, would meet criteria for stroke prevention therapy.

Project description:BackgroundDigital technologies are increasingly used in health research to collect real-world data from wider populations. A new wave of digital health studies relies primarily on digital technologies to conduct research entirely remotely. Remote digital health studies hold promise to significant cost and time advantages over traditional, in-person studies. However, such studies have been reported to typically suffer from participant attrition, the sources for which are still largely understudied.ObjectiveTo contribute to future remote digital health study planning, we present a conceptual framework and hypotheses for study enrollment and completion. The framework introduces 3 participation criteria that impact remote digital health study outcomes: (1) participant motivation profile and incentives or nudges, (2) participant task complexity, and (3) scientific requirements. The goal of this study is to inform the planning and implementation of remote digital health studies from a person-centered perspective.MethodsWe conducted a scoping review to collect information on participation in remote digital health studies, focusing on methodological aspects that impact participant enrollment and retention. Comprehensive searches were conducted on the PubMed, CINAHL, and Web of Science databases, and additional sources were included in our study from citation searching. We included digital health studies that were fully conducted remotely, included information on at least one of the framework criteria during recruitment, onboarding or retention phases of the studies, and included study enrollment or completion outcomes. Qualitative analyses were performed to synthesize the findings from the included studies.ResultsWe report qualitative findings from 37 included studies that reveal high values of achieved median participant enrollment based on target sample size calculations, 128% (IQR 100%-234%), and median study completion, 48% (IQR 35%-76%). Increased median study completion is observed for studies that provided incentives or nudges to extrinsically motivated participants (62%, IQR 43%-78%). Reducing task complexity for participants in the absence of incentives or nudges did not improve median study enrollment (103%, IQR 102%-370%) or completion (43%, IQR 22%-60%) in observational studies, in comparison to interventional studies that provided more incentives or nudges (median study completion rate of 55%, IQR 38%-79%). Furthermore, there were inconsistencies in measures of completion across the assessed remote digital health studies, where only around half of the studies with completion measures (14/27, 52%) were based on participant retention throughout the study period.ConclusionsFew studies reported on participatory factors and study outcomes in a consistent manner, which may have limited the evidence base for our study. Our assessment may also have suffered from publication bias or unrepresentative study samples due to an observed preference for participants with digital literacy skills in digital health studies. Nevertheless, we find that future remote digital health study planning can benefit from targeting specific participant profiles, providing incentives and nudges, and reducing study complexity to improve study outcomes.

Project description:ImportancePostoperative atrial fibrillation (POAF) occurring after cardiac surgery is associated with adverse outcomes. Whether POAF persists beyond discharge is not well defined.ObjectiveTo determine whether continuous cardiac rhythm monitoring enhances detection of POAF among cardiac surgical patients during the first 30 days after hospital discharge compared with usual care.Design, setting, and participantsThis study is an investigator-initiated, open-label, multicenter, randomized clinical trial conducted at 10 Canadian centers. Enrollment spanned from March 2017 to March 2020, with follow-up through September 11, 2020. As a result of the COVID-19 pandemic, enrollment stopped on July 17, 2020, at which point 85% of the proposed sample size was enrolled. Cardiac surgical patients with CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes, prior stroke or transient ischemic attack, vascular disease, age 65-74 years, female sex) score greater than or equal to 4 or greater than or equal to 2 with risk factors for POAF, no history of preoperative AF, and POAF lasting less than 24 hours during hospitalization were enrolled.InterventionsThe intervention group underwent continuous cardiac rhythm monitoring with wearable, patch-based monitors for 30 days after randomization. Monitoring was not mandated in the usual care group within 30 days after randomization.Main outcomes and measuresThe primary outcome was cumulative AF and/or atrial flutter lasting 6 minutes or longer detected by continuous cardiac rhythm monitoring or by a 12-lead electrocardiogram within 30 days of randomization. Prespecified secondary outcomes included cumulative AF lasting 6 hours or longer and 24 hours or longer within 30 days of randomization, death, myocardial infarction, ischemic stroke, non-central nervous system thromboembolism, major bleeding, and oral anticoagulation prescription.ResultsOf the 336 patients randomized (163 patients in the intervention group and 173 patients in the usual care group; mean [SD] age, 67.4 [8.1] years; 73 women [21.7%]; median [interquartile range] CHA2DS2-VASc score, 4.0 [3.0-4.0] points), 307 (91.4%) completed the trial. In the intent-to-treat analysis, the primary end point occurred in 32 patients (19.6%) in the intervention group vs 3 patients (1.7%) in the usual care group (absolute difference, 17.9%; 95% CI, 11.5%-24.3%; P < .001). AF lasting 6 hours or longer was detected in 14 patients (8.6%) in the intervention group vs 0 patients in the usual care group (absolute difference, 8.6%; 95% CI, 4.3%-12.9%; P < .001).Conclusions and relevanceIn post-cardiac surgical patients at high risk of stroke, no preoperative AF history, and AF lasting less than 24 hours during hospitalization, continuous monitoring revealed a significant increase in the rate of POAF after discharge that would otherwise not be detected by usual care. Studies are needed to examine whether these patients will benefit from oral anticoagulation therapy.Trial registrationClinicalTrials.gov Identifier: NCT02793895.

Dataset Information

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial.

Objectives

Methods

Results

Conclusions

Trial registration

Publications

Digital recruitment and enrollment in a remote nationwide trial of screening for undiagnosed atrial fibrillation: Lessons from the randomized, controlled mSToPS trial.

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