Post Operative PainSPBNCT06522698
Optimizing Research Data Acquisition With Smart Pill Bottles
A study testing Smart Pill Bottle in people with Post Operative Pain and Opioid Use, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Opioid Use
- What is being tested?
- Smart Pill Bottle
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2024to 1 Jul 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
Montreal East, Quebec, H1T2M4
Pascal Laferriere-Langlois, MD, MSc, +1-819-432-5847, pascal.laferriere-langlois@umontreal.ca
Pascal Laferriere-Langlois, MD, MSc
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Post Operative Pain, Opioid Use
- Being tested
- Smart Pill Bottle
- Keywords
- Major abdominal surgery, Connected Technology, Chronic Pain, Postoperative pain, Opioid consumption, Smart Pill Bottles
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Pill BottleDevice
Also called Connected 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smart Pill Bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Secondary outcomes (6)
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.
Measured: 3 months
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.
Measured: 3 months
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)
Measured: Up to12 months
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)
Measured: 7 days
Prevalence of Chronic post-surgical pain 90 days after surgery
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).
Measured: 7 days
Change in Quality of Life
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pascal Laferrière-Langlois, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Pascal Laferriere-Langlois, MD, MSc, Principal investigator, Ciusss de L'Est de l'Île de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522698
- Sponsor's protocol ID
- 2025-3801
- Acronym
- SPB
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Catala-Lopez F, Aleixandre-Benavent R, Caulley L, Hutton B, Tabares-Seisdedos R, Moher D, Alonso-Arroyo A. Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis. Trials. 2020 Jan 7;21(1):34. doi: 10.1186/s13063-019-3944-9.
PubMed 31910857Vinkers CH, Lamberink HJ, Tijdink JK, Heus P, Bouter L, Glasziou P, Moher D, Damen JA, Hooft L, Otte WM. The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement. PLoS Biol. 2021 Apr 19;19(4):e3001162. doi: 10.1371/journal.pbio.3001162. eCollection 2021 Apr.
PubMed 33872298Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.
PubMed 26955090Toledano MB, Smith RB, Brook JP, Douglass M, Elliott P. How to Establish and Follow up a Large Prospective Cohort Study in the 21st Century--Lessons from UK COSMOS. PLoS One. 2015 Jul 6;10(7):e0131521. doi: 10.1371/journal.pone.0131521. eCollection 2015.
PubMed 26147611Barrera-Valencia C, Perea-Florez EX. Comparison of Costs in Teledermatology Using PC and Camera Versus Smartphone. Telemed J E Health. 2024 Jun;30(7):e2087-e2095. doi: 10.1089/tmj.2023.0369. Epub 2024 Apr 26.
PubMed 38669106Pavlovic I, Miklavcic D. Web-based electronic data collection system to support electrochemotherapy clinical trial. IEEE Trans Inf Technol Biomed. 2007 Mar;11(2):222-30. doi: 10.1109/titb.2006.879581.
PubMed 17390992Zijp TR, Touw DJ, van Boven JFM. User Acceptability and Technical Robustness Evaluation of a Novel Smart Pill Bottle Prototype Designed to Support Medication Adherence. Patient Prefer Adherence. 2020 Mar 20;14:625-634. doi: 10.2147/PPA.S240443. eCollection 2020.
PubMed 32256053Aldeer M, Javanmard M, Martin RP. A Review of Medication Adherence Monitoring Technologies. Applied System Innovation. 2018; 1(2):14. https://doi.org/10.3390/asi1020014
Schwed A, Fallab CL, Burnier M, Waeber B, Kappenberger L, Burnand B, Darioli R. Electronic monitoring of compliance to lipid-lowering therapy in clinical practice. J Clin Pharmacol. 1999 Apr;39(4):402-9. doi: 10.1177/00912709922007976.
PubMed 10197299Ellsworth GB, Burke LA, Wells MT, Mishra S, Caffrey M, Liddle D, Madhava M, O'Neal C, Anderson PL, Bushman L, Ellison L, Stein J, Gulick RM. Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):73-80. doi: 10.1097/QAI.0000000000002519.
PubMed 33306564Toscos T, Drouin M, Pater JA, Flanagan M, Wagner S, Coupe A, Ahmed R, Mirro MJ. Medication adherence for atrial fibrillation patients: triangulating measures from a smart pill bottle, e-prescribing software, and patient communication through the electronic health record. JAMIA Open. 2020 Apr 28;3(2):233-242. doi: 10.1093/jamiaopen/ooaa007. eCollection 2020 Jul.
PubMed 32734164Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Huo T, Guo Y, Shenkman E, Muller K. Assessing the reliability of the short form 12 (SF-12) health survey in adults with mental health conditions: a report from the wellness incentive and navigation (WIN) study. Health Qual Life Outcomes. 2018 Feb 13;16(1):34. doi: 10.1186/s12955-018-0858-2.
PubMed 29439718Nafziger AN, Barkin RL. Opioid Therapy in Acute and Chronic Pain. J Clin Pharmacol. 2018 Sep;58(9):1111-1122. doi: 10.1002/jcph.1276. Epub 2018 Jul 9.
PubMed 29985526Schug SA, Lavand'homme P, Barke A, Korwisi B, Rief W, Treede RD; IASP Taskforce for the Classification of Chronic Pain. The IASP classification of chronic pain for ICD-11: chronic postsurgical or posttraumatic pain. Pain. 2019 Jan;160(1):45-52. doi: 10.1097/j.pain.0000000000001413.
PubMed 30586070
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Research Data Acquisition With Smart Pill Bottles: A Feasibility and Implementation Study
- ClinicalTrials.gov ID
- NCT06522698
- Acronym / sponsor ID
- SPB / 2025-3801
- Conditions
- Post Operative Pain, Opioid Use
- Keywords
- Major abdominal surgery, Connected Technology, Chronic Pain, Postoperative pain, Opioid consumption, Smart Pill Bottles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Pill Bottle Data Collection Group | Experimental | Device: Smart Pill BottleGroup of patients in which data on postoperative opioid medication consumption will be collected through the use of smart pill bottles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Smart Pill BottleAlso: Connected Pill BottlePatients 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. | Device | Smart Pill Bottle Data Collection Group |
Primary outcome
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)
6 secondary outcomes
The quality of data acquired through the SPBs
Time frame: 3 months
The costs incurred from carrying out the project
Time frame: 3 months
The time for recruitment of patients
Time frame: Up to12 months
Prevalence of persistent opioid consumption 90 days after surgery
Time frame: 7 days
Prevalence of Chronic post-surgical pain 90 days after surgery
Time frame: 7 days
Change in Quality of Life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Background: PubMed 31910857Catala-Lopez F, Aleixandre-Benavent R, Caulley L, Hutton B, Tabares-Seisdedos R, Moher D, Alonso-Arroyo A. Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis. Trials. 2020 Jan 7;21(1):34. doi: 10.1186/s13063-019-3944-9.
- Background: PubMed 33872298Vinkers CH, Lamberink HJ, Tijdink JK, Heus P, Bouter L, Glasziou P, Moher D, Damen JA, Hooft L, Otte WM. The methodological quality of 176,620 randomized controlled trials published between 1966 and 2018 reveals a positive trend but also an urgent need for improvement. PLoS Biol. 2021 Apr 19;19(4):e3001162. doi: 10.1371/journal.pbio.3001162. eCollection 2021 Apr.
- Background: PubMed 26955090Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.
- Background: PubMed 26147611Toledano MB, Smith RB, Brook JP, Douglass M, Elliott P. How to Establish and Follow up a Large Prospective Cohort Study in the 21st Century--Lessons from UK COSMOS. PLoS One. 2015 Jul 6;10(7):e0131521. doi: 10.1371/journal.pone.0131521. eCollection 2015.
- Background: PubMed 38669106Barrera-Valencia C, Perea-Florez EX. Comparison of Costs in Teledermatology Using PC and Camera Versus Smartphone. Telemed J E Health. 2024 Jun;30(7):e2087-e2095. doi: 10.1089/tmj.2023.0369. Epub 2024 Apr 26.
- Background: PubMed 17390992Pavlovic I, Miklavcic D. Web-based electronic data collection system to support electrochemotherapy clinical trial. IEEE Trans Inf Technol Biomed. 2007 Mar;11(2):222-30. doi: 10.1109/titb.2006.879581.
- Background: PubMed 32256053Zijp TR, Touw DJ, van Boven JFM. User Acceptability and Technical Robustness Evaluation of a Novel Smart Pill Bottle Prototype Designed to Support Medication Adherence. Patient Prefer Adherence. 2020 Mar 20;14:625-634. doi: 10.2147/PPA.S240443. eCollection 2020.
- BackgroundAldeer M, Javanmard M, Martin RP. A Review of Medication Adherence Monitoring Technologies. Applied System Innovation. 2018; 1(2):14. https://doi.org/10.3390/asi1020014
- Background: PubMed 10197299Schwed A, Fallab CL, Burnier M, Waeber B, Kappenberger L, Burnand B, Darioli R. Electronic monitoring of compliance to lipid-lowering therapy in clinical practice. J Clin Pharmacol. 1999 Apr;39(4):402-9. doi: 10.1177/00912709922007976.
- Background: PubMed 33306564Ellsworth GB, Burke LA, Wells MT, Mishra S, Caffrey M, Liddle D, Madhava M, O'Neal C, Anderson PL, Bushman L, Ellison L, Stein J, Gulick RM. Randomized Pilot Study of an Advanced Smart-Pill Bottle as an Adherence Intervention in Patients With HIV on Antiretroviral Treatment. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):73-80. doi: 10.1097/QAI.0000000000002519.
- Background: PubMed 32734164Toscos T, Drouin M, Pater JA, Flanagan M, Wagner S, Coupe A, Ahmed R, Mirro MJ. Medication adherence for atrial fibrillation patients: triangulating measures from a smart pill bottle, e-prescribing software, and patient communication through the electronic health record. JAMIA Open. 2020 Apr 28;3(2):233-242. doi: 10.1093/jamiaopen/ooaa007. eCollection 2020 Jul.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Individual participant dataSharing planned: No
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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.
Pascal Laferriere-Langlois, MD, MSc principal investigator
Ciusss de L'Est de l'Île de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Pill Bottle in people with Post Operative Pain and Opioid Use, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascal Laferriere-Langlois, MD, MSc (+1-819-432-5847, pascal.laferriere-langlois@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to data collection method (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06522698, which also lists 20 linked publications.
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 26 Jul 2024.