Optimizing Research Data Acquisition With Smart Pill Bottles (SPB)

July 25, 2024 updated by: Pascal Laferrière-Langlois, Ciusss de L'Est de l'Île de Montréal

Optimizing Research Data Acquisition With Smart Pill Bottles: A Feasibility and Implementation Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 hasn't 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-l'Est-de-l'Île-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 patient's 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 Type

Interventional

Enrollment (Estimated)

155

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montréal-Est, Quebec, Canada, H1T2M4
        • Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
        • Contact:
        • Principal Investigator:
          • Pascal Laferriere-Langlois, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All consenting adult patients (age >17 years) undergoing major abdominal surgery via laparotomy (any open surgery involving the abdominal compartment or its wall, excluding appendectomies, inguinal hernia repairs, abdominal wall hernia repairs, and incisional hernia repairs)

Exclusion Criteria:

  • Patients enrolled in the historical cohort (POCAS study)
  • Patients currently participating in another study
  • Patients planned to undergo additional surgery within 90 days after the surgery
  • Patients who do not understand French or English.
  • Patients planned to be redirected to a secondary care or rehabilitation establishment following discharge
  • Patients with diagnosed cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart Pill Bottle Data Collection Group
Group of patients in which data on postoperative opioid medication consumption will be collected through the use of smart pill bottles.
Device: Smart Pill Bottle
Patients in the intervention group will have their opioid medication consumption monitored through a smart pill bottle that records medication usage and streamlines the data into an online platform accessible by the medical staff. This group will also fill out surveys delivered through the smart pill bottle's online platform.
Other Names:
  • Connected Pill Bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient adherence to data collection method
Time Frame: 3 months
The percentage of patients that will have used the smart pill bottle (SPB) until the end of the 90-day period or until the absence of pain, as opposed to any change in medication intake strategy that results in ceasing the use of the SPB. (High percentage is a better outcome)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The quality of data acquired through the SPBs
Time Frame: 3 months
The granularity of data acquired, the preciseness of data points, the number of loss of follow-up compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources.
3 months
The costs incurred from carrying out the project
Time Frame: 3 months
The costs incurred from carrying out the project compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources.
3 months
The time for recruitment of patients
Time Frame: Up to12 months
The time for recruitment of patients compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources. (Lower time is a better outcome)
Up to12 months
Prevalence of persistent opioid consumption 90 days after surgery
Time Frame: 7 days
Persistent opioid consumption (POC) 90 days after surgery as reported by the SPBs. POC will be defined as consumption of any quantity of opioids in the 7 days prior to the 90-day interrogation. This definition will be accurate for both preoperative chronic and non-chronic opioid users. (Higher rate of persistent consumption is a worse outcome)
7 days
Prevalence of Chronic post-surgical pain 90 days after surgery
Time Frame: 7 days
The presence of chronic post-surgical pain (CPSP) in the 7 days prior to the interrogation (interrogation occurs at 90 days post-op). CPSP will be defined as any pain at the surgical site for patients who had pain at that site before surgery (by 1 point on the general numerical pain scoring question of the BPI questionnaire) (12).
7 days
Change in Quality of Life
Time Frame: 3 months
The change in the reported quality of life at 90 days post-op. QOL will be measured as a continuous variable on the SF-12 questionnaire.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciusss de L'Est de l'Île de Montréal

Investigators

  • Principal Investigator: Pascal Laferriere-Langlois, MD, MSc, Ciusss de L'Est de l'Île de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 25, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 25, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-3801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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