18 and older, any sex, with Medication Adherence or Mobile Application. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Usability of the SAM AppPrimary· At baseline, prior to hospital discharge
Users were observed as they used the app, following the "think aloud protocol". This involved users verbalizing their thoughts as they perform a standardized set of tasks, while being audio-recorded.A field assistant familiar with the SAM app observed and recorded users as they accessed SAM and completed the following standardized tasks: log in, peruse drug information, send the pharmacist a message, add a medication review, use the interaction checker, and use the side effect checker. User performance was observed and registered by a trained research assistant to establish if the user was abl
Severity scale mean, login
Group
Value
95% CI
SAM Intervention Group
1.14
± 0.51
Severity scale mean, view drug information
Group
Value
95% CI
SAM Intervention Group
1.32
± 0.74
Severity scale mean, send a message
Group
Value
95% CI
SAM Intervention Group
1.35
± 0.65
Severity scale mean, review a medication
Group
Value
95% CI
SAM Intervention Group
1.81
± 1.09
Severity scale mean, check side effects of a specific medication
Group
Value
95% CI
SAM Intervention Group
1.13
± 0.45
Severity scale mean, check side effect profile of all medications (side effect checker)
Group
Value
95% CI
SAM Intervention Group
1.71
± 0.88
Severity scale mean, use interaction checker
Group
Value
95% CI
SAM Intervention Group
1.17
± 0.37
User Acceptance of and Satisfaction With the SAM AppPrimary· 2 weeks post-discharge
Participants in the intervention arm completed the Technology Acceptance Model (TAM) Questionnaire 2 weeks following discharge from hospital. The questionnaire measures users' perceived ease of use and perceived usefulness of the SAM app and their intention to use the app. The TAM questionnaire is self-administered, and consists of 38 questions on a Likert scale of 1 to 7, with responses being strongly agree (7), moderately agree (6), somewhat agree (4), neutral (4), somewhat disagree (3), moderately disagree (2), and strongly disagree (1). Responses higher on the Likert scale typically reflec
TAM domain: behavioral intention
Group
Value
95% CI
SAM Intervention Group
5.17
± 2.12
TAM domain: perceived usefulness
Group
Value
95% CI
SAM Intervention Group
5.29
± 2.11
TAM domain: subjective norm
Group
Value
95% CI
SAM Intervention Group
3.81
± 1.74
TAM domain: relevance
Group
Value
95% CI
SAM Intervention Group
4.86
± 1.78
TAM domain: output quality
Group
Value
95% CI
SAM Intervention Group
5.44
± 1.65
TAM domain: result demonstrability
Group
Value
95% CI
SAM Intervention Group
5.06
± 1.82
TAM domain: perceived ease of use
Group
Value
95% CI
SAM Intervention Group
5.65
± 2.02
TAM domain: computer self-efficacy
Group
Value
95% CI
SAM Intervention Group
5.60
± 2.00
Proportion of Medication Changes That Are Adhered toPrimary· 30 days post-discharge
Pharmacy claims data from the public insurance provider will be used to identify community medications dispensed to participating patients in the 30 days following hospital discharge. These data will be compared with the patient's hospital discharge prescription to identify non-adherence to in-hospital medication changes. Non-adherence to in-hospital treatment changes in the 30-day post-discharge period will be defined as (1) failure to fill newly prescribed medications, (2) re-filling a previous prescription that was stopped at discharge, or (3) filling a previous prescription whose dosage wa
Proportion of all medication changes adhered to
Group
Value
95% CI
SAM Intervention Group
0.837
Usual Care Group
0.778
Proportion of all new medications adhered to
Group
Value
95% CI
SAM Intervention Group
0.727
Usual Care Group
0.617
Proportion of all dose changes adhered to
Group
Value
95% CI
SAM Intervention Group
0.909
Usual Care Group
0.818
Proportion of all discontinued medications adhered to
Group
Value
95% CI
SAM Intervention Group
0.935
Usual Care Group
0.943
Sponsor's own description
Adverse drug events (ADEs) are a leading cause of death in North America, with over 2 million ADEs causing 100,000 deaths every year and millions in economic costs. The majority of ADEs that occur within 30 days of discharge from hospital are related to prescription medications and of these, more than 50% are preventable. Among the causes of ADEs are incomplete and unclear medication lists, and a lack of patient understanding and adherence. Patients are usually discharged from hospital on substantially difference medication regiments than those prior to admission. In the absence of supportive mechanisms that ensure patients' understanding of their medication list, adherence to prescribed medication changes is likely to be reduced and the subsequent risk of ADEs increased. Secondary analyses from a recently conducted randomized controlled trial (RCT) by our team suggest that more than 50% of study patient were non-adherent to at least one in-hospital medication change, and that this non-adherence significantly increased the risk of hospital re-admission and emergency department visits in the 30 days post-discharge. Furthermore, analyses of interview data suggest that non-adherence may be driven by unclear communication with patients about medication changes and the reasons for these changes, as well as difficulties in managing complex dosing schedules and drug regimen information. There is therefore a clear need to implement and evaluate patient support mechanisms that reduce non-adherence to essential changes in therapy following hospitalization.
The objective of this project is to conduct a pilot RCT that will evaluate the usability of a medication management mobile application and its efficacy in reducing non-adherence to in-hospital medication changes following discharge. We will randomize 100 patients from the internal medicine unit of the McGill University Health Centre (MUHC) Glen site to either the intervention or control arm. Patients in the control arm will receive usual care (i.e. no medication management support), whereas those in the intervention arm will receive a tablet with the installed mobile application. The application will integrate prescription claims data from the Régie de l'assurance maladie du Québec (RAMQ) for the 3-month period prior to hospital admission with the patient's discharge prescription to generate a patient-friendly medication list, along with details of in-hospital medication changes. The app will also offer a number of features designed to maximize patient understanding and adherence, including pill images, patient-friendly drug monographs, weekly dosing schedules, drug alerts, home refill services, and features that connect with the patient's caregiver and hospital pharmacist.
At 1 week post-discharge, study coordinators will conduct a usability assessment to obtain patient feedback on the app (via a technology acceptance questionnaire) and to document usability using the "think aloud" protocol, which is based on observing and recording patients as they use the application and verbalize any thoughts that might occur to them. Qualitative analysis of recorded and transcribed sessions will then be used to assess the technology's ease of use, user-friendliness, efficiency, and any features that may cause confusion, frustration, or user errors.
Non-adherence to in-hospital treatment changes will be assessed by comparing patients' discharge prescriptions with medications dispensed in the 30 days following hospital discharge (obtained from RAMQ pharmacy claims). We will compare, between intervention and control groups, the average number of in-hospital medication changes not adhered to in the 30-day follow-up period.
This project will assess a technological intervention that has the potential to improve patient adherence to in-hospital medication changes and may subsequently reduce the occurrence of ADEs. Given the high costs associated with ADEs, this small investment has the potential to incur significant cost savings for the Quebec healthcare system.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07420634 — Multilevel Ecological and COM-B Determinants of Medication Adherence in Adults With Diabetes
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by McGill University
Last refreshed: 7 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04676165.