Health TrialsbyHealthPanel

Optimizing Research Data Acquisition With Smart Pill Bottles

ConditionsPost Operative PainOpioid Use
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Smart Pill Bottle

    Device

    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.

Treatment groups

155 Participants
are divided into 1 treatment group
Group A: Smart Pill Bottle Data Collection GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient adherence to data collection method

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)

Time frame
3 months

Secondary outcomes

1

The quality of data acquired through the SPBs

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.

Time frame
3 months
2

The costs incurred from carrying out the project

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.

Time frame
3 months
3

The time for recruitment of patients

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)

Time frame
Up to12 months
4

Prevalence of persistent opioid consumption 90 days after surgery

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)

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: