Clinical trial NCT02204540: Feasibility of Using Webcams in Clinical Studies
Official title: Validation of Video Monitoring to Assess Compliance in Clinical Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video Monitoring Via Webcams
Keywords: Webcams, video monitoring, compliance, adherence
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study tests the feasibility of having study participants use webcams to participate in research studies. The study scientists hypothesize (1) that webcams will be an adequate method of detecting a participant's ability to perform a tasks for a clinical trial (e.g., swallowing a pill, eating food) and (2) that a majority of study participants would be willing to use a webcam to participate in a research study.

Detailed description: In the first phase of this study, the study scientists will research and compare technologies that will be used in video monitoring via webcam. The study team will also develop a standardized protocol for using the webcam technology through hands-on testing (without the use of study participants).

In the second phase of this study, video monitoring via webcam will be tested. Specifically, the study scientists will see whether the video recordings can be used to assess compliance to clinical interventions. Study participants will be recruited from among Pennington Biomedical Research Center employees and assigned to be either evaluators or testers. Testers will act as if they were study participants in a clinical study who are supposed to adhere to an intervention such as swallowing a pill or consuming food. They will be video-recorded by webcam while performing these tasks. Evaluators will then try to detect how well the testers followed the instructions for the task through in-person observation and by watching video recordings. Data from these tests will then be used to see whether watching the video recordings is as effective as watching in-person.

In the third phase of this study, past, current, and potential study participants at Pennington Biomedical Research Center will be surveyed to determine their comfort with using webcams and their likeliness to opt to use webcams to participate in clinical studies.

Eligibility criteria: Inclusion Criteria:

* Pennington Biomedical Research Center employees and trainees
* Age 18 years and older

Exclusion Criteria:

* Any employees who directly report to and are directly employed by the study's principal investigator

Primary outcomes:
measure: Sensitivity of Detecting Non-Compliance
timeFrame: 1 Month
Secondary outcomes:
measure: Specificity and Inter-Rater Agreement of Detecting Non-Compliance
timeFrame: 1 Month
measure: Attitudes Towards Using Webcams To Participate in Clinical Interventions
timeFrame: 1 year
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Courtney M Peterson, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: