Feasibility of Using Webcams in Clinical Studies

NCT ID: NCT02204540

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2015-08-31

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.

Conditions

Video Monitoring Via Webcams

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mock study intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Mock study intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Courtney Peterson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Courtney M Peterson, PhD, MSc

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 2014-033

Identifier Type: -

Identifier Source: org_study_id