ArticleJMIR formative research2021
Improving Efficiency of Clinical Studies Using a Total Digital Approach: Prospective Observational Study.
Article in JMIR formative research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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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.
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Who cites it
5 citing papers in PubMed, 7 citations in OpenAlex.
- Improving Patient Engagement in Phase 2 Clinical Trials With a Trial-Specific Patient Decision Aid: Development and Usability Study.Journal of medical Internet research · 2025Article
- The NORwegian atrial fibrillation self-SCREENing (NORSCREEN) trial: rationale and design of a randomized controlled trial.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2024Article
- Digital recruitment and compliance to treatment recommendations in the Norwegian Atrial Fibrillation self-screening pilot study.European heart journal. Digital health · 2024Article
- Fully digital self-screening for atrial fibrillation with patch electrocardiogram.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023Article
- Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn general, most clinical studies have long recruitment periods. Signing the informed consent is particularly time-consuming when the participant must meet physically with the researchers. Therefore, introducing fully web-based techniques with the use of eAuthentication (BankID) and new digital electrocardiogram (ECG) monitoring could speed up inclusion time, increase adherence, and also reach out to more remote regions.
objectiveThe objectives of this study were to explore whether inclusion of a large number of participants could be realized quickly by using a total digital approach both for information and signing of informed consent, along with ECG monitoring and instant feedback on a mobile device. We also explored whether this approach can increase adherence in registration of ECG recordings and answering questionnaires, and if it would result in a more geographically uniform distribution of participants covering a wide age span.
methodsWomen with palpitations were intensively studied over 2 months by means of a handheld ECG monitoring device (Coala Heart Monitor). The device connects to a smartphone or tablet, which allows the participants to obtain the results immediately. Recruitment, study information, and signing the informed consent form with the help of BankID were performed in a completely digital manner.
resultsBetween March and May 2018, 2424 women indicated their interest in participating in the study. On June 19, 2018, presumptive participants were invited to log in and register. After 25 days, 1082 women were included in the study; among these, 1020 women fulfilled the inclusion criteria, 913 of whom completed all phases of the study: recording ECG using the handheld device, completion of the prestudy questionnaires, and completion of the poststudy questionnaires 2 months after the ECG recordings. The dropout rate was 9%. In total, 101,804 ECG recordings were made. The mean age was 56 (SD 11) years (range 21-88 years) and 35 participants were 75 years or older. The participants were evenly distributed between living in the countryside and in cities.
conclusionsTotal digital inclusion recruitment of 1082 participants was achieved in only 25 days, and resulted in a good geographical distribution, excellent adherence, and ability to reach a vast age span, including elderly women. Studies using a total digital design would be particularly appealing during a pandemic since physical contact should be avoided as much as possible.
trial registrationISRCTN Registry ISRCTN22495299; http://www.isrctn.com/ISRCTN22495299.
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