Optimizing Research Data Acquisition With Smart Pill Bottles

NCT06522698 | Not Yet Recruiting

• 1 other identifier: 2025-3801
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Opioid Use

Keywords

Major abdominal surgery; Connected Technology; Chronic Pain; Postoperative pain; Opioid consumption; Smart Pill Bottles

Outcome Measures

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)

  3 months

Secondary Outcomes (6)

• The quality of data acquired through the SPBs

  3 months

• The costs incurred from carrying out the project

  3 months

• The time for recruitment of patients

  Up to12 months

• Prevalence of persistent opioid consumption 90 days after surgery

  7 days

• Prevalence of Chronic post-surgical pain 90 days after surgery

  7 days

Study Arms (1)

Smart Pill Bottle Data Collection Group

EXPERIMENTAL

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

Interventions

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.

Also known as: Connected Pill Bottle

Smart Pill Bottle Data Collection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead

Study Sites (1)

Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal

Montreal East, Quebec, H1T2M4, Canada

Location

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MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pascal Laferriere-Langlois, MD, MSc

  Ciusss de L'Est de l'Île de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Laferriere-Langlois, MD, MSc

CONTACT

+1-819-432-5847; pascal.laferriere-langlois@umontreal.ca

Nadia Godin, NR

CONTACT

514-252-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)