Nemours Children's Health System, in a clinical study of children with asthma and aged 12 to 17, is using telemedicine technology which includes videos with accompanying tags that patients and parents can click to get more information and affirm what they learn, and also to obtain informed consent during clinical trials.

The goal is to give a more visually engaging way for participants to digest the information. Early results show that those watching video presentations retained more information about the study and their roles in the study than those who filled out traditional consent forms.

Patients twice daily, using an app on their mobile phone, report symptoms and also submit data from use of the EasyOne spirometer which measures the air capacity of the lungs. This data can show clinicians the force being used when taking a dose of medication and then blowing in the spirometer, and patients may be reminded to blow harder.

Or, a clinician could schedule a “FaceTime” visit with the patient and parent, which is a video consultation to show them how best to use the spirometer. Patients then hold their phone or other mobile device up to the screen so the clinician can see the quality of the deep breaths and hard blowing.

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Presently, 80 percent of clinical trials are delayed because too few people sign up to participate, says Kathryn Blake, director at Nemours’ Center for Pharmacogenomics and Translational Research, and the lead investigator on the trial. “As part of this project, we looked at new ways to obtain informed consent by utilizing a 15-minute video that incorporates eLearning principles for a more visually engaging way for participants of all literacy and health literacy levels to digest the information, rather than having the children come to the clinic.”

As children and parents watch the video, they can click on tables for more information and access multiple choice questions to reaffirm what they learned.

In a separate control group, children and parents simply read the traditional 13-page consent form. Researchers then compared comprehension of information of both groups via a 17-item questionnaire.

The questionnaire showed no initial difference in comprehension between the groups who watched the video and those who read and signed the consent form.

However, five months later comprehension questions were given again and this time caregivers of participants retained more information about the study than those who had five months earlier completed the consent forms.

How comprehension was maintained five months later remains a mystery for now, Blake says, and more research will be done. Research also is being done on the effectiveness of the treatment. For now, researchers believe that the program “is not inferior to current standards,” she adds.

Funding of the project started in 2012 with the first patient enrolled 11 months later. In February 2017, enrollment was completed and now Nemours is analyzing the program by pulling up the data and looking at the time it took researchers to put the program together with videos, compared to patients having to make multiple clinic visits, and the costs, such as parental time off from work for a clinic visit, associated with each method.

A satisfaction survey found most participants preferred online visits with a clinician via FaceTime rather than coming in the clinic, especially since the program developed a process so FaceTime could be done on patients’ schedules.

“In the future, we can see this program working for large studies, but at just one institution, it probably is not cost-effective,” Blake notes. “But people like video so we need to develop new multimedia ways to present the information.’’

The clinical trial is available here.

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