ObvioHealth orchestrated an in-home observational study to measure infant crying and fussing captured via a recording device, compared with data gathered from parental e-diaries and daily questionnaires. Ultimately, the data was to be analyzed by the client to increase understanding of infantile colic, its triggers, and whether there was a need for the development of products to better meet the needs of infants. ObvioHealth’s digital platform made it easy for participants to complete daily study activities, and more than 81 percent of participants were 100 percent compliant with the study protocol.
For a duration of 14 days, 24-hour daily monitoring of the infant by way of recording device was completed and later paired with the input from the daily questionnaire and e-diary application. ObvioHealth’s app collected all data points.
To overcome user challenges with the client’s recording device, ObvioHealth implemented mandatory training for subjects, and members of the study team were made available to assist subjects when necessary.
Despite challenges with the recording device, ObvioHealth maintained data integrity and limited patient drop-outs by increasing its communication and touch-points with subjects to ensure they felt supported.
The total duration of crying/fussing recorded by parents through the app was higher than the results collected by the recording device. Perceptions of not only the duration of the crying but the nature of crying/fussing were inconsistent with the events recorded via the recorder.
The study saw high rates of compliance. The majority of participants who took part in the study (over 81 percent) were 100 percent compliant and able to provide 14 days of data gathered via the recording device and e-diaries.