Accepted for/Published in: JMIR Formative Research
Date Submitted: Feb 24, 2020
Date Accepted: Jan 17, 2021
Improving efficiency of clinical studies using a total digital approach
ABSTRACT
Background:
In general, most clinical studies in patients and healthy volunteers take a longer time to finalize than original planned because of the long recruitment periods. Especially signing the informed consent is time-consuming
Objective:
The objectives were to explore if inclusion of a large number of participants could be done quickly by using a total digital approach both for information and signing of informed consent and if a totally web-based inclusion would result in a geographically more uniform distribution of participants
Methods:
In the Red Heart Study, women with palpitations were intensively studied during two months by means of a handheld ECG monitor device (Coala Heart Monitor), It connects to a smartphone or tablet so the participants can get an immediate response of the results. Recruitment, study information and signing the informed consent were total digital. The informed consent was signed digitally with the help of Swedish eAuthentication (Bank ID).
Results:
Between March and May 2018, 2 424 persons announced interest to participate in the study. On June 19th, 2018, presumptive participants were invited to log in to the website to answer baseline questionnaires and sign informed consent. The recruitment was completed on the 13th of July-after 25 days with 1 089 women included. About 100°000 thumb ECG and 100°000 chest ECG recordings were performed. The mean age of the women was 56±11 years (range 21-88 years). Thirty-five participants were 75 years or older. No participant had any difficulties with this the full digital approach. The participants were evenly distributed between living in the countryside (n=525) and in the cities (n=438).
Conclusions:
To the best of our knowledge, this is the first-time researchers have used eAuthentication at online signing of informed consent. Fully digitalized inclusion recruitment of 1 089 participants was done in 45 days. This novel approach also resulted in a more evenly geographically distribution of participants Clinical Trial: ISRCTN22495299
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