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Completed

NCT Number: NCT02204540

Feasibility of Using Webcams in Clinical Studies

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.

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Key information

Conditions

Video Monitoring Via Webcams Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mock study intervention

Behavioral

Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.

Primary outcomes

  1. Sensitivity of Detecting Non-Compliance

    Time frame: 1 Month

    The sensitivity (true positive rate, as a percentage of total non-compliant events) of observers charged with detecting non-compliance to a mock study intervention will be tested both via in-person monitoring and monitoring by webcam. The mock study interventions that will be monitored will include pill swallowing and eating. Non-compliance events will be chosen from a defined list of non-compliant behaviors (e.g., tampering with the pill, spitting food into a napkin and not eating it), and will be performed by mock study participants. The observers will record the number of non-compliant events they actually observe the mock study participants performing. This data will be analyzed as described here in order to determine the validity of monitoring non-compliance by webcam, in comparison to in-person monitoring.

Secondary outcomes

  1. Specificity and Inter-Rater Agreement of Detecting Non-Compliance

    Time frame: 1 Month

    The specificity (false positive rate, as a percentage of distinct events) and inter-rater agreement (as a percentage of total events and as calculated via Cohen's kappa) of observers who are charged with monitoring and recording non-compliance events in-person versus by webcam will also be assessed, similarly as described above.

  2. Attitudes Towards Using Webcams To Participate in Clinical Interventions

    Time frame: 1 year

    A survey will be given to determine potential and current study participants' comfort with video recording technologies and assess their likeliness to opt to use webcams to participate in a clinical study.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Official study title

Validation of Video Monitoring to Assess Compliance in Clinical Interventions

Acronym: WEBCAM

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 30, 2014
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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