Feasibility of Using Webcams in Clinical Studies (WEBCAM)

Validation of Video Monitoring to Assess Compliance in Clinical Interventions

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.

Study Overview

• Status: Completed
• Conditions: Video Monitoring Via Webcams
• Intervention / Treatment: Behavioral: Mock study intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitoring by webcam; Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming food) while being recorded and monitored by webcam.	Behavioral: Mock study intervention; Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.
Active Comparator: In-person monitoring; Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming good) while being monitored in-person.	Behavioral: Mock study intervention; Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of Detecting Non-Compliance	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.	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity and Inter-Rater Agreement of Detecting Non-Compliance	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.	1 Month
Attitudes Towards Using Webcams To Participate in Clinical Interventions	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.	1 year

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Courtney M Peterson, PhD, MSc, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 27, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Webcams, video monitoring, compliance, adherence
• Other Study ID Numbers: PBRC 2014-033