<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02204540</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 2014-033</org_study_id>
    <nct_id>NCT02204540</nct_id>
  </id_info>
  <brief_title>Feasibility of Using Webcams in Clinical Studies</brief_title>
  <acronym>WEBCAM</acronym>
  <official_title>Validation of Video Monitoring to Assess Compliance in Clinical Interventions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests the feasibility of having study participants use webcams to participate in&#xD;
      research studies. The study scientists hypothesize (1) that webcams will be an adequate&#xD;
      method of detecting a participant's ability to perform a tasks for a clinical trial (e.g.,&#xD;
      swallowing a pill, eating food) and (2) that a majority of study participants would be&#xD;
      willing to use a webcam to participate in a research study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first phase of this study, the study scientists will research and compare technologies&#xD;
      that will be used in video monitoring via webcam. The study team will also develop a&#xD;
      standardized protocol for using the webcam technology through hands-on testing (without the&#xD;
      use of study participants).&#xD;
&#xD;
      In the second phase of this study, video monitoring via webcam will be tested. Specifically,&#xD;
      the study scientists will see whether the video recordings can be used to assess compliance&#xD;
      to clinical interventions. Study participants will be recruited from among Pennington&#xD;
      Biomedical Research Center employees and assigned to be either evaluators or testers. Testers&#xD;
      will act as if they were study participants in a clinical study who are supposed to adhere to&#xD;
      an intervention such as swallowing a pill or consuming food. They will be video-recorded by&#xD;
      webcam while performing these tasks. Evaluators will then try to detect how well the testers&#xD;
      followed the instructions for the task through in-person observation and by watching video&#xD;
      recordings. Data from these tests will then be used to see whether watching the video&#xD;
      recordings is as effective as watching in-person.&#xD;
&#xD;
      In the third phase of this study, past, current, and potential study participants at&#xD;
      Pennington Biomedical Research Center will be surveyed to determine their comfort with using&#xD;
      webcams and their likeliness to opt to use webcams to participate in clinical studies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity of Detecting Non-Compliance</measure>
    <time_frame>1 Month</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity and Inter-Rater Agreement of Detecting Non-Compliance</measure>
    <time_frame>1 Month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes Towards Using Webcams To Participate in Clinical Interventions</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Video Monitoring Via Webcams</condition>
  <arm_group>
    <arm_group_label>Monitoring by webcam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming food) while being recorded and monitored by webcam.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>In-person monitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming good) while being monitored in-person.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mock study intervention</intervention_name>
    <description>Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.</description>
    <arm_group_label>In-person monitoring</arm_group_label>
    <arm_group_label>Monitoring by webcam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pennington Biomedical Research Center employees and trainees&#xD;
&#xD;
          -  Age 18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any employees who directly report to and are directly employed by the study's&#xD;
             principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Courtney M Peterson, PhD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pennington Biomedical Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Courtney Peterson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Webcams, video monitoring, compliance, adherence</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02204540
org study id: PBRC 2014-033
nct id: NCT02204540
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Sensitivity of Detecting Non-Compliance
time frame: 1 Month
description: 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.
measure: Specificity and Inter-Rater Agreement of Detecting Non-Compliance
time frame: 1 Month
description: 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.
measure: Attitudes Towards Using Webcams To Participate in Clinical Interventions
time frame: 1 year
description: 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.
arm group label: Monitoring by webcam
arm group type: Experimental
description: Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming food) while being recorded and monitored by webcam.
arm group label: In-person monitoring
arm group type: Active Comparator
description: Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming good) while being monitored in-person.
intervention type: Behavioral
intervention name: Mock study intervention
description: Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.
arm group label: In-person monitoring
arm group label: Monitoring by webcam
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Courtney M Peterson, PhD, MSc
role: Principal Investigator
affiliation: Pennington Biomedical Research Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Courtney Peterson
investigator title: Principal Investigator