| NCT ID | NCT05371548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Robyn Tamblyn |
| Condition | Medication Adherence |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,250 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,250 participants in total. It began in 2023-02-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: Almost half of patients discharged from hospital are re-admitted or return to the emergency department (ED) within 90 days. Patient nonadherence to medication changes during hospitalization and the use of potentially inappropriate medications (PIMs) both contribute to the risk of adverse events post-discharge. Smart About Meds (SAM) is a patient-centered mobile application designed to target medication nonadherence and PIMs use. This protocol describes a randomized controlled trial (RCT) to evaluate the effectiveness of SAM. Methods \& Analysis: A pragmatic, stratified RCT will be conducted among 3,250 patients discharged from internal medicine, cardiac care, cardiac surgery, vascular surgery, and respiratory units of the Royal Victoria Hospital and the Montreal General Hospital. At discharge, patients will be randomized 1:1 to usual care or the SAM intervention. SAM integrates novel user-centered features (e.g. continuously updated medication list with pill images, side-effect checker, interaction checker) with pharmacist monitoring to tackle post-discharge nonadherence to new medication regimens. SAM also notifies patients of PIMS in their regimen, with advice to discuss with their physician. Following discharge, patients will be followed for 90 days, during which the occurrence of the composite outcome of ED visits, hospital readmissions, or death will be measured. Secondary outcomes will include the individual components of the composite outcome, nonadherence to medication changes, defined as failure to fill a new prescription, filling a modified prescription at the incorrect dose, or filling discontinued medications, secondary medication adherence, patient empowerment, and health-related quality of life. An intention-to-treat analysis will evaluate the effectiveness of SAM. Multivariable logistic regression will estimate differences between treatment groups in the proportion of patients nonadherent to at least one medication change. With a sample size of 3,250, there will be 80% power to detect a 5% absolute reduction in this outcome. Two-way interaction terms will test hypothesized modifiers of SAM's effectiveness, including hospital, unit, age, sex, gender and comorbidity burden. Binary and continuous secondary outcomes will be assessed using multivariable logistic and linear regression, respectively.
Eligibility Criteria
Inclusion Criteria: * Covered by provincial (RAMQ) health insurance plan * Covered by provincial (RAMQ) prescription drug insurance plan * Owns a smartphone or tablet with internet connection * At least one medication prescribed at discharge * Speak and read English or French * Age 18+ Exclusion Criteria: * Discharged to rehabilitation center or to long-term care * Transferred to a non-study unit
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05371548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Medication Adherence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05371548 currently recruiting?
Yes, NCT05371548 is actively recruiting participants. Contact the research team at bettina.habib@mcgill.ca for enrollment information.
Where is the NCT05371548 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05371548 clinical trial?
NCT05371548 is sponsored by Robyn Tamblyn. The trial plans to enroll 3,250 participants.