Assessing Clinical Trial Technology: Evaluating the TIME Study


Electronic data capture has quickly become the preferred means of capturing and storing clinical study data. Cost and efficiency savings have been documented, yet it is unclear how acceptable this technology is to participants. An evaluation survey has been created to assess participant attitudes to a clinical study website. Methods: The TIME study is a clinical study that uses an online methodology to compare morning dosing of hypertensive medication with evening dosing. An evaluation questionnaire was developed and sent to participants to assess their views of the online methodology. The final questionnaire was organised into themes: functionality, personal contact, and trust. Negative and positive phrasing was used along with a Likert-type scale. The survey underwent 4 iterations before the content was finalised. 149 responses were received from 263 invitations. The mean scores for the three themes in the final 14 item questionnaire were as follows: functionality, 3.99; personal contact, 3.89; and trust, 4.03; suggesting an overall positive perception of the study methodology. Concerns regarding use of data and privacy were present in the responses but the overwhelming majority of responders chose to take part due to a sense of altruism and recognising the need for clinical research. This questionnaire was specifically created to evaluate the TIME study website. Additional improvements to the questionnaire are necessary for more general usage. The feedback provided from participants reveals areas of the study website that require further development, and has reaffirmed known concerns participants have about the use of their data.

User acceptance is a prerequisite to reaping the potential benefits of any new technology. In health care, patient satisfaction is oÑ–en used as an indicator of the service performance and reflects patient’s values and expectations. When there is a match between the care expected and received, patients are satisfied. In other words, satisfaction is influenced not only by experiences but also by prior expectation. Нe Treatment in Morning vs. Evening (TIME) study is a clinical trial evaluating morning dosing of antihypertensive medication versus evening dosing to assess whether one provides greater cardiovascular protection. Нe study data and all follow ups are captured entirely online, using internet technology. Нe online methodology used in the TIME study is novel and it is unclear how acceptable this use of technology will be to study participants. In order to maintain or improve participation rates and minimise waste in clinical research it will be necessary to evaluate any new methods or innovations . Нere have been several patient satisfaction surveys developed to evaluate telemedicine, or information technology in healthcare, including: Telemedicine Perception Questionnaire (TMPQ), Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) and Telemedicine Satisfaction Survey (TSQ). Нese questionnaires have all been designed specificall\ for use in telemedicine, and none were

deemed suitable for use in assessing the TIME study. Problems with the aforementioned questionnaires include lack of measures of reliability or validity and limited evidence of practical application. Patient selection criteria were not always clearly specified so it is possible sampling bias may have be an issue. It was identified by the authors that a suitable questionnaire was required that could be used to gather feedback for online-only clinical studies using a similar methodology as the TIME study.

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Managing Editor
Journal of Clinical Trials