Video Monitoring Via WebcamsWEBCAMNCT02204540
Feasibility of Using Webcams in Clinical Studies
A study testing Mock study intervention in people with Video Monitoring Via Webcams, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Video Monitoring Via Webcams
- What is being tested?
- Mock study intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pennington Biomedical Research Center employees and trainees
- Age 18 years and older
Who cannot join
- Any employees who directly report to and are directly employed by the study's principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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
- Being tested
- Mock study intervention
- Keywords
- Webcams, video monitoring, compliance, adherence
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mock study interventionBehavioural
Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring by webcam | Experimental | Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming food) while being recorded and monitored by webcam. Receives: Behavioral: Mock study intervention |
| In-person monitoring | Active comparator | Participants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming good) while being monitored in-person. Receives: Behavioral: Mock study intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video Monitoring Via WebcamsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney Peterson, Pennington Biomedical Research Center
- Investigators
- Courtney M Peterson, PhD, MSc, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204540
- Sponsor's protocol ID
- PBRC 2014-033
- Acronym
- WEBCAM
- Status last verified
- Oct 2015
- First submitted
- 27 Jul 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Video Monitoring to Assess Compliance in Clinical Interventions
- ClinicalTrials.gov ID
- NCT02204540
- Acronym / sponsor ID
- WEBCAM / PBRC 2014-033
- Conditions
- Video Monitoring Via Webcams
- Keywords
- Webcams, video monitoring, compliance, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring by webcam | Experimental | Behavioral: Mock study interventionParticipants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming food) while being recorded and monitored by webcam. |
| In-person monitoring | Active comparator | Behavioral: Mock study interventionParticipants will perform a task for a mock clinical study (e.g., swallowing a pill, consuming good) while being monitored in-person. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pennington Biomedical Research Center employees and trainees
- Age 18 years and older
Key exclusion criteria (1 listed)
- Any employees who directly report to and are directly employed by the study's principal investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mock study interventionParticipants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored. | Behavioural | In-person monitoring, Monitoring by webcam |
Primary outcome
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.
2 secondary outcomes
Specificity and Inter-Rater Agreement of Detecting Non-Compliance
Time frame: 1 Month
Attitudes Towards Using Webcams To Participate in Clinical Interventions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney M Peterson, PhD, MSc principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mock study intervention in people with Video Monitoring Via Webcams, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Detecting Non-Compliance (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.