Medication AdherenceNCT05371548
Smart About Meds (SAM) RCT
A study testing SAM mobile application in people with Medication Adherence, run by Robyn Tamblyn at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- SAM mobile application
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,250 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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+
Who cannot join
- Discharged to rehabilitation center or to long-term care
- Transferred to a non-study unit
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec
Bettina Habib, MSc, MScPH
About this study
Official title: Evaluating the Effectiveness of the Smart About Meds (SAM) Medication Management Mobile Application: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Medication Adherence
- Being tested
- SAM mobile application
- Keywords
- medication adherence, mobile application, medication management, patient empowerment, randomized controlled trial
- Medical subject headings
- Medication Adherence, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM mobile applicationDevice
See description of intervention group
| Study group | Role | What they receive |
|---|---|---|
| Intervention (SAM app) | Experimental | Patients will receive training in and access to the SAM app at discharge. SAM uses prescribed and dispensed medication data to display a continuously updated drug list and provides patients and caregivers with tools to address barriers to adherence.
Drug information: Provides patient-friendly drug monographs. Interaction checker: Generates drug-drug interactions between the patient's medications and other OTC drugs.
Adherence alerts: Uses decision algorithms to alert users to adherence problems with the new regimen.
Side effect checker: Displays possible side effects for each medication and frequency of occurrence.
PIMs alerts: Alerts patients to potentially inappropriate medications in their list.
Pharmacist connect: Connects users with pharmacists through a secured messaging service.
Social connect: Allows users to share medication experiences. Caregiver connect: Allows patients to enroll caregivers who can use the app. Weekly medication schedule \& pill reminders Receives: Device: SAM mobile application |
| Control (usual care) | No intervention | Patients will receive usual care at discharge. On study units, medication reconciliation is conducted for all patients. Patients have their community medication list obtained via fax from their community pharmacy. The list is validated by the unit pharmacist who then reconciles it with admission orders, and recommends changes as needed to the attending physician. At discharge, the community drug list is reconciled with medications administered in hospital and the discharge prescription is generated by the attending physician or resident, classifying each medication as new medication, dose modification, discontinued therapy, or continued community medication. The discharge prescription is provided to the patient. Patients fill their discharge prescription at their community pharmacy. If there are questions about changes to the community drug list, the pharmacist will ask the patient, and if not clear will contact the discharging physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED visits, hospital readmissions, and deaths (composite)
This is a composite, binary outcome of having experienced an ED visit, hospital readmission, or death in the 90 days post-discharge. In Quebec, physicians must record the location of the services they provide to be remunerated on a fee-for-service basis. These medical services claims data are timely and accurate in measuring hospitalization occurrence and length of stay. The hospitalization database, which records admission and discharge diagnoses and procedures for all acute care hospitalizations in Quebec, will be used to collect additional descriptive information on the reasons for hospitalization and to re-validate the medical services data. Patients will be classified as having an ED visit or hospital readmission if they received a service whose location is recorded as an ED or inpatient hospital unit, respectively. Post-discharge deaths will be retrieved from the RAMQ beneficiary database.
Measured: 90 days post-discharge
Secondary outcomes (5)
Individual components of the primary composite outcome
ED visits, hospital readmissions and deaths occurring in the 90 days post-discharge, each of which will be measured separately as a binary secondary outcome.
Measured: 90 days post-discharge
Nonadherence to medication changes
This is a binary outcome of a patient having adhered or not to medication changes in the discharge prescription. Nonadherence to medication changes is defined as a failure to fill a new prescription within 90 days of discharge, filling a modified prescription at the incorrect dose, or filling any discontinued medication in 90 days.
Measured: 90 days post-discharge
Secondary adherence
Disease-modifying medications are defined as those that prevent health deterioration and typically need to be taken on a daily basis to be effective. A list of these medications will be compiled based on the World Health Organization's list of essential medicines. Secondary adherence will be measured for each disease-modifying medication that is filled using the medication possession ratio, which is calculated as the days of supply (based on the duration of dispensed prescription during follow-up) divided by the number of days of follow-up. Left-over supply prior to admission, when relevant, will be included in the calculation and only supply within the 90-day period for post-discharge dispensations will be included. In Quebec, over 94% of prescriptions are dispensed for 30 days or less, which should provide an accurate measure of persistence.
Measured: 90 days post-discharge
Patient and caregiver empowerment
Patient and caregiver empowerment will be measured using the Patient Reported Outcome Measurement Information System (PROMIS) Self-Efficacy Measure for Managing Medication and Treatments (PROMIS-SE Meds). This 8-item measure assesses patient confidence in managing medication schedules of varying complexity and in challenging situations, such as when running out of supply or when adverse effects occur. Five-point ratings scales assess confidence levels. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self efficacy.
Measured: 90 days post-discharge
Patient health-related quality of life
Patient health-related quality of life (HRQoL) will be measured using the Patient Reported Outcome Measurement Information System-29 (PROMIS-29), which measures quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance). Five-point ratings scales assess HRQoL. Scores are calibrated as T-scores (mean 50, SD 10), where higher scores indicate greater self HRQoL.
Measured: 90 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 Feb 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robyn Tamblyn
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Robyn Tamblyn, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371548
- Sponsor's protocol ID
- 2022-7858
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers can request access to a trial dataset by contacting the PI or Research Project Manager. The dataset will include de-identified, processed participant data that underly the results reported in the main trial publication. Requesting researchers must ensure that their proposed use of the data has been approved by an independent review committee. A Data Transfer Agreement will govern the transfer of the data, the use of the data by the recipient, and the rights and obligations of both parties.
Publications
Tamblyn R, Habib B, Buckeridge DL, Weir DL, Frolova E, Alattar R, Rogozinsky J, Beauchamp C, Pupo R, Bartlett SJ, McDonald E. Evaluating the effectiveness of the Smart About Meds (SAM) mobile application among patients discharged from hospital: protocol of a randomised controlled trial. BMJ Open. 2024 Nov 24;14(11):e084492. doi: 10.1136/bmjopen-2024-084492.
PubMed 39581737
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Smart About Meds (SAM) Medication Management Mobile Application: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05371548
- Acronym / sponsor ID
- 2022-7858
- Conditions
- Medication Adherence
- Keywords
- medication adherence, mobile application, medication management, patient empowerment, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,250 participants (estimated)
- Lead sponsor
- Robyn TamblynUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 May 2022 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (SAM app) | Experimental | Device: SAM mobile applicationPatients will receive training in and access to the SAM app at discharge. SAM uses prescribed and dispensed medication data to display a continuously updated drug list and provides patients and caregivers with tools to address barriers to adherence. Drug information: Provides patient-friendly drug monographs. Interaction checker: Generates drug-drug interactions between the patient's medications and other OTC drugs. Adherence alerts: Uses decision algorithms to alert users to adherence problems with the new regimen. Side effect checker: Displays possible side effects for each medication and frequency of occurrence. PIMs alerts: Alerts patients to potentially inappropriate medications in their list. Pharmacist connect: Connects users with pharmacists through a secured messaging service. Social connect: Allows users to share medication experiences. Caregiver connect: Allows patients to enroll caregivers who can use the app. Weekly medication schedule \& pill reminders |
| Control (usual care) | No intervention | –Patients will receive usual care at discharge. On study units, medication reconciliation is conducted for all patients. Patients have their community medication list obtained via fax from their community pharmacy. The list is validated by the unit pharmacist who then reconciles it with admission orders, and recommends changes as needed to the attending physician. At discharge, the community drug list is reconciled with medications administered in hospital and the discharge prescription is generated by the attending physician or resident, classifying each medication as new medication, dose modification, discontinued therapy, or continued community medication. The discharge prescription is provided to the patient. Patients fill their discharge prescription at their community pharmacy. If there are questions about changes to the community drug list, the pharmacist will ask the patient, and if not clear will contact the discharging physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Discharged to rehabilitation center or to long-term care
- Transferred to a non-study unit
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 |
|---|---|---|
| SAM mobile applicationSee description of intervention group | Device | Intervention (SAM app) |
Primary outcome
ED visits, hospital readmissions, and deaths (composite)
Time frame: 90 days post-discharge
This is a composite, binary outcome of having experienced an ED visit, hospital readmission, or death in the 90 days post-discharge. In Quebec, physicians must record the location of the services they provide to be remunerated on a fee-for-service basis. These medical services claims data are timely and accurate in measuring hospitalization occurrence and length of stay. The hospitalization database, which records admission and discharge diagnoses and procedures for all acute care hospitalizations in Quebec, will be used to collect additional descriptive information on the reasons for hospitalization and to re-validate the medical services data. Patients will be classified as having an ED visit or hospital readmission if they received a service whose location is recorded as an ED or inpatient hospital unit, respectively. Post-discharge deaths will be retrieved from the RAMQ beneficiary database.
5 secondary outcomes
Individual components of the primary composite outcome
Time frame: 90 days post-discharge
Nonadherence to medication changes
Time frame: 90 days post-discharge
Secondary adherence
Time frame: 90 days post-discharge
Patient and caregiver empowerment
Time frame: 90 days post-discharge
Patient health-related quality of life
Time frame: 90 days post-discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 39581737Tamblyn R, Habib B, Buckeridge DL, Weir DL, Frolova E, Alattar R, Rogozinsky J, Beauchamp C, Pupo R, Bartlett SJ, McDonald E. Evaluating the effectiveness of the Smart About Meds (SAM) mobile application among patients discharged from hospital: protocol of a randomised controlled trial. BMJ Open. 2024 Nov 24;14(11):e084492. doi: 10.1136/bmjopen-2024-084492.
- Individual participant dataSharing planned: Yes. Researchers can request access to a trial dataset by contacting the PI or Research Project Manager. The dataset will include de-identified, processed participant data that underly the results reported in the main trial publication. Requesting researchers must ensure that their proposed use of the data has been approved by an independent review committee. A Data Transfer Agreement will govern the transfer of the data, the use of the data by the recipient, and the rights and obligations of both parties.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAM mobile application in people with Medication Adherence, run by Robyn Tamblyn 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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bettina Habib, MSc MScPH (514-396-1156, bettina.habib@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED visits, hospital readmissions, and deaths (composite) (time frame: 90 days post-discharge). 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 NCT05371548, which also lists 1 linked publication.
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 15 Oct 2026.