Evidence map›Paper›PMID 35764796›Full record

ArticleNPJ digital medicine2022

Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP).

Ashish Sarraju, Clark Seninger, Vijaya Parameswaran, Christina Petlura, Tamara Bazouzi, Kiranbir Josan, Upinder Grewal, Thomas Viethen, Hardi Mundl, Joachim Luithle and 7 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ digital medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04471623 (Decentralized Trial in Atrial Fibrillation Patients), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04471623 nacompletednot on this map

Decentralized Trial in Atrial Fibrillation Patients (DeTAP): Validation of a Combined Digital Health Technology Approach to Fully Decentralize an Intervention to Administer, Promote, and Track Oral Anticoagulant Therapy

TypeinterventionalSponsorStanford UniversityRan2020 to 2021Enrolled102ConditionsAtrial FibrillationArmsUse of DeTAP App and Home Devices
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Sample-size determination for decentralized clinical trials.International journal of epidemiology · 2025
    Article
  10. Review
  11. Article
  12. Article
  13. Narrative review of telemedicine applications in decentralized research.Journal of clinical and translational science · 2024
    Review
  14. Review
  15. Article
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  18. Review
  19. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Ashish SarrajuDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Clark SeningerCenter for Digital Health, Stanford University School of Medicine, Palo Alto, CA, USA.
Vijaya ParameswaranDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.ORCID http://orcid.org/0000-0002-0984-9938
Christina PetluraStanford Center for Clinical Research (SCCR), Palo Alto, CA, USA.
Tamara BazouziDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Kiranbir JosanDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Upinder GrewalBayer AG, Wuppertal, Germany.
Thomas ViethenBayer AG, Wuppertal, Germany.ORCID http://orcid.org/0000-0002-5334-1197
Hardi MundlBayer AG, Wuppertal, Germany.
Joachim LuithleBayer AG, Wuppertal, Germany.
Leonard BasobasStanford Center for Clinical Research (SCCR), Palo Alto, CA, USA.
Alexis TourosStanford Center for Clinical Research (SCCR), Palo Alto, CA, USA.
Michael J T SeniorHuma Therapeutics Ltd, London, UK.ORCID http://orcid.org/0000-0002-9064-7769
Koen De LombaertYuzu Labs PBC, San Jose, CA, USA.
Kenneth W MahaffeyDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Mintu P TurakhiaDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.ORCID http://orcid.org/0000-0001-8025-0904
Rajesh DashDivision of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA. rhombus@stanford.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

Identifiers

PMID35764796
PMCPMC9240050

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.