Optimizing Research Data Acquisition With Smart Pill Bottles
NCT ID: NCT06522698
Last Updated: 2024-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
155 participants
INTERVENTIONAL
2024-09-01
2025-07-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Pascal Laferrière-Langlois
Clinical assistant professor
Principal Investigators
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Pascal Laferriere-Langlois, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Ciusss de L'Est de l'Île de Montréal
Locations
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Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
Montreal East, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Vinkers 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.
Setia MS. Methodology Series Module 1: Cohort Studies. Indian J Dermatol. 2016 Jan-Feb;61(1):21-5. doi: 10.4103/0019-5154.174011.
Toledano 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.
Barrera-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.
Pavlovic 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.
Zijp 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.
Aldeer 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.
Ellsworth 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.
Toscos 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.
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
Huo 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.
Nafziger 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.
Schug 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.
Richebe P, Capdevila X, Rivat C. Persistent Postsurgical Pain: Pathophysiology and Preventative Pharmacologic Considerations. Anesthesiology. 2018 Sep;129(3):590-607. doi: 10.1097/ALN.0000000000002238.
Page MG, Kudrina I, Zomahoun HTV, Croteau J, Ziegler D, Ngangue P, Martin E, Fortier M, Boisvert EE, Beaulieu P, Charbonneau C, Cogan J, Daoust R, Martel MO, Neron A, Richebe P, Clarke H. A Systematic Review of the Relative Frequency and Risk Factors for Prolonged Opioid Prescription Following Surgery and Trauma Among Adults. Ann Surg. 2020 May;271(5):845-854. doi: 10.1097/SLA.0000000000003403. No abstract available.
https://www.thess-corp.fr/
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Schirle L, Stone AL, Morris MC, Osmundson SS, Walker PD, Dietrich MS, Bruehl S. Leftover opioids following adult surgical procedures: a systematic review and meta-analysis. Syst Rev. 2020 Jun 11;9(1):139. doi: 10.1186/s13643-020-01393-8.
Other Identifiers
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2025-3801
Identifier Type: -
Identifier Source: org_study_id
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