Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale

Abstract

Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be noninferior and will be less expensive compared to a traditional pediatric asthma trial. Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed consent process by viewing a multi-media website containing a consent video and study material in the streamlined trial. Participants are provided an iPad with WiFi and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are compared with participants completing a similarly designed traditional trial comparing the same treatments within the same pediatric health-system. After 8 weeks of open-label Advair 250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent 250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to determine study costs. Results Participants have been enrolled in the streamlined and traditional trials and recuitment is ongoing. Conclusions This project will provide important information on both clinical and economic outcomes for a novel method of conducting clinical trials. The results will be broadly applicable to trials of other diseases.

A cognitive approach for design of a multimedia informed consent video and website in pediatric research

“…The clinical study procedures (spirometry, questionnaires, diary cards) are the same in the experimental and control trials. A full description of the study design, inclusion and exclusion criteria, rationale, commonalities, and differences between the experimental and control groups has been previously published [47]. …”

The Role of Advanced Technology Product Animations on Informing Patients with Gonarthrosis Preoperatively

“…In order for the information during the informing process to be permanent in the mind of the patient, the patient should be aware of stimuli and allow them to be stored in memory. The use of visual images and symbols during informing allows the individual to give more attention to the informing; also, images are more memorable than words (10,14,16). In the present study, it was aimed to evaluate the available knowledge levels of the patients who had gonarthrosis and were informed with standard verbal and written texts, and the changes in their levels of knowledge after visual animation.…”

“…Also, the lack of informed consent of the individuals before the medical procedure or the failure to obtain it appropriately causes essential ethical and legal problems in clinical practice (9). The conventional informed consent is generally in the form of insufficient written texts (10,11). Studies show that patients do not understand the main elements of the consent in their informed consent performed with written or verbal information (10,(12)(13)(14)(15).…”

“…The conventional informed consent is generally in the form of insufficient written texts (10,11). Studies show that patients do not understand the main elements of the consent in their informed consent performed with written or verbal information (10,(12)(13)(14)(15). In particular, it is seen that elderly patients with gonarthrosis cannot read written informing texts, or they are too lazy to read them.…”

Smart Technology in Lung Disease Clinical Trials

“…Step Down Study (LASST). 27 Those randomized to MICT are provided an iPad to complete health information diaries and questionnaires in an online database at home. Aside from the initial and the final clinic visits, participants complete virtual FaceTime visits with the iPad.…”