Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522698
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Optimizing Research Data Acquisition With Smart Pill Bottles
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimizing Research Data Acquisition With Smart Pill Bottles A Feasibility and Implementation Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPB
Brief Summary:
The goal of this clinical trial is to learn if smart pill bottles can be used as a tool to optimize data collection in clinical trials by increasing the quality of data collected and limiting the associated cost The main questions it aims to answer are
Is the use of smart pill bottles a feasible method of data collection in clinical trials in terms of patient adherence
Is the data collected by the smart pill bottles of higher quality than that collected through human resources What is the impact of the use of smart pill bottles on the costs involved in clinical trials
Researchers will collect data on postoperative opioid medication consumption with the smart pill bottle and assess the adherence of patients to the device along with the quality of data collected and the costs involved in the process
Participants will
Use the smart pill bottle to consume opioid medication following surgery for 3 months At the end of the 3 month period the group will have filled out surveys detailing their opioid consumption surgical pain and other relevant information
Is the use of smart pill bottles a feasible method of data collection in clinical trials in terms of patient adherence
Is the data collected by the smart pill bottles of higher quality than that collected through human resources What is the impact of the use of smart pill bottles on the costs involved in clinical trials
Researchers will collect data on postoperative opioid medication consumption with the smart pill bottle and assess the adherence of patients to the device along with the quality of data collected and the costs involved in the process
Participants will
Use the smart pill bottle to consume opioid medication following surgery for 3 months At the end of the 3 month period the group will have filled out surveys detailing their opioid consumption surgical pain and other relevant information
Detailed Description:
Several studies involving harnessing new technology to approach data collection have suggested that a streamlined and automated method of collecting data through connected technology can help set up cohort studies more cost-effectively Evaluating the use of a connected device as a research tool in clinical trials and comparing it with traditional data collection using human resources would provide valuable insights into its efficiency and effectiveness Smart medication adherence monitoring devices are a novel technology that provides objective and granular medication utilization data along with engaging patients with their treatment Particularly the smart pill bottle SPB is a rapidly developing technology that allows for medication monitoring of solid doses with the use of electronic sensors that can collect data on medication usage in real time and offer direct communication between patients and healthcare professionals or trialists SPBs have shown efficacy in monitoring compliance and possibly increasing medication adherence in the clinical setting and the technology has been suggested as a potential research tool that would allow automatic collection of granular and precise data on the time of medication intake dose and frequency However there hasnt been a trial comparing the efficacy of using SPBs for data collection in clinical trials versus the traditional method reliant on human resources in comparable contexts Based on the properties of SPBs and available literature supporting the automatization and streamlining of data in clinical trials the investigators believe that the use of these devices may allow data collection of higher quality regarding granularity number of losses of follow-up completeness missing data points along with a reduction of costs incurred by avoiding the use of human resources
The aim of this study is to evaluate the feasibility of using smart pill bottles SPBs to optimize data collection in the context of randomized control trials
The project will be a prospective observational study conducted at the CIUSSS-de-lEst-de-lÎle-de-Montréal Hôpital Maisonneuve-Rosemont over a period of 6 to 12 months
To do so 155 patients undergoing major abdominal surgery with postoperative opioid medication prescription will be recruited These patients medication consumption will be monitored with the use of a smart pill bottle for a duration of 90 days The results of this cohort will be compared with a historical cohort from a previous study conducted within the same hospital network The protocol for the current trial was purposefully designed to be comparable to that of this historical cohort
A loan of 50 SPBs will be obtained from Thess Corporate Company producing smart pill bottles
The aim of this study is to evaluate the feasibility of using smart pill bottles SPBs to optimize data collection in the context of randomized control trials
The project will be a prospective observational study conducted at the CIUSSS-de-lEst-de-lÎle-de-Montréal Hôpital Maisonneuve-Rosemont over a period of 6 to 12 months
To do so 155 patients undergoing major abdominal surgery with postoperative opioid medication prescription will be recruited These patients medication consumption will be monitored with the use of a smart pill bottle for a duration of 90 days The results of this cohort will be compared with a historical cohort from a previous study conducted within the same hospital network The protocol for the current trial was purposefully designed to be comparable to that of this historical cohort
A loan of 50 SPBs will be obtained from Thess Corporate Company producing smart pill bottles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None