SAM App for Medication Adherence

Overseen By Bettina Habib, MSc MScPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Robyn Tamblyn

Disqualifiers: Rehabilitation, Long-term care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

3250 Participants Needed

Trial Summary

What is the purpose of this 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. 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It focuses on helping you manage your medications better after being discharged from the hospital.

What data supports the effectiveness of the SAM App treatment for medication adherence?

Research suggests that mobile applications, like the SAM App, can help people stick to their medication schedules, especially for those with long-term health conditions. A pilot study of the SAM App showed it might improve how well people follow their medication plans after leaving the hospital. ^{1 2 3 4 5}

Is the SAM App for Medication Adherence safe for humans?

The pilot study of the Smart About Meds (SAM) app aimed to evaluate its potential to improve medication adherence and monitor adverse events, but specific safety data is not detailed in the available research. Additionally, a broader review of medication adherence apps highlighted concerns about data security and privacy, suggesting that none of the apps, including SAM, have undergone certification for safety and should not be recommended by healthcare providers without further clinical studies. ^{1 4 5 6 7}

How is the SAM app treatment different from other treatments for medication adherence?

The SAM app is unique because it is a mobile application designed to help patients manage their medications after leaving the hospital, focusing on improving adherence to medication changes. Unlike traditional methods, it offers a patient-centered, scalable, and potentially more effective way to support medication adherence through technology. ^{1 4 8 9 10}

Eligibility Criteria

The SAM trial is for patients who speak English or French, have provincial health and prescription insurance, own a smart device with internet, and had a medication change at hospital discharge. It excludes those sent to rehab or transferred to non-study units.

Inclusion Criteria

My medication was changed when I was last discharged from the hospital.

Owns a smartphone or tablet with internet connection

My prescription drugs are covered by provincial insurance.

Exclusion Criteria

Transferred to a non-study unit

I was sent to rehab after hospital discharge.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients receive training in and access to the SAM app at discharge, which includes features like medication list updates, adherence alerts, and pharmacist connect.

At discharge

1 visit (in-person)

Follow-up

Participants are monitored for the occurrence of ED visits, hospital readmissions, or death, as well as secondary outcomes like medication adherence and quality of life.

90 days

Data Analysis

Intention-to-treat analysis and multivariable logistic regression to evaluate the effectiveness of SAM.

Treatment Details

Interventions

• Smart About Meds (SAM) mobile application

Trial Overview This study tests the SAM app designed to help patients stick to their new medication plans after leaving the hospital. The app shows updated meds lists with pictures, checks for side effects and interactions, and warns about inappropriate meds.

Participant Groups

Group I: Intervention (SAM app) Experimental Treatment 1 Intervention

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

Group II: Control (usual care) Active Control 1 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.

Smart About Meds (SAM) mobile application is already approved in Canada for the following indications:

Approved in Canada as Smart About Meds for:

• Medication adherence support

Who Is Running the Clinical Trial?

Robyn Tamblyn

Lead Sponsor

Trials

1

Recruited

3,300+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

A systematic review of 14 studies involving 1,785 participants found that mobile applications significantly improve medication adherence in adults with chronic diseases, with a moderate effect size (Cohen's d = 0.40).

Participants reported high satisfaction with the mobile apps, with 91.7% expressing contentment with all aspects, indicating that these tools are not only effective but also well-received by users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications on Medication Adherence in Adults with Chronic Diseases: A Systematic Review and Meta-Analysis. Peng, Y., Wang, H., Fang, Q., et al.[2023]

The Digital Drag and Drop Pillbox (D-3 Pillbox) was tested on 25 hospitalized heart failure patients, showing high feasibility for teaching medication management skills, with 98% achieving accurate medication recognition by discharge.

Despite the high accuracy in recognizing medications, only 25% of patients felt they had a good understanding of their medication responsibilities, indicating a need for improved education on medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Digital Drag and Drop Pillbox: Design and Feasibility of a Skill-based Education Model to Improve Medication Management. Granger, BB., Locke, SC., Bowers, M., et al.[2018]

My/Treatment/Medication (MyTMed) is an innovative system designed to monitor medication adherence using a digital pill that activates in the stomach, providing real-time data on whether patients are taking their medications as prescribed.

This system not only tracks adherence but also facilitates communication between patients and healthcare providers, potentially improving treatment outcomes for chronic diseases by addressing nonadherence issues directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible Biosensors for Real-Time Medical Adherence Monitoring: MyTMed. Chai, PR., Rosen, RK., Boyer, EW.[2020]

The pilot study involving 49 patients showed that those using the Smart About Meds (SAM) app had better adherence to medication changes after hospital discharge (83.7%) compared to those receiving usual care (77.8%).

Patients using the SAM app also had a lower rate of hospital readmissions (8.7%) compared to the control group (15.4%), suggesting that the app may help reduce adverse events related to medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. Habib, B., Buckeridge, D., Bustillo, M., et al.[2022]

A qualitative study involving 24 patients aged 50 and older revealed that the perceived benefits of a mobile app for medication adherence included accessibility and privacy, which could encourage its use.

Patients also identified barriers to app usage, such as concerns about appearance, cost, and reliability, along with desired features like customization and communication tools, highlighting the importance of user-centered design in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community pharmacy patient perceptions of a pharmacy-initiated mobile technology app to improve adherence. DiDonato, KL., Liu, Y., Lindsey, CC., et al.[2015]

A study evaluated 2,140 medication adherence apps, ultimately identifying only seven that met eligibility criteria, with none achieving high evaluation scores, indicating a lack of effective options for improving medication adherence.

The top-rated apps, such as Medisafe and MyTherapy, received moderate scores, and none had undergone certification for safety and data protection, highlighting the need for regulatory oversight and further clinical studies to assess their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Medication Adherence Support: Could Healthcare Providers Recommend Mobile Health Apps? Backes, C., Moyano, C., Rimaud, C., et al.[2022]

The integration of advanced digital and IT systems is crucial for improving medication safety, as they can help address new challenges that arise with smart technologies in prescribing.

Empowering patients through better education and communication about their medications is essential for enhancing drug adherence and ensuring safer prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Improving smart medication management': an online expert discussion. Bates, DW., Cheng, HY., Cheung, NT., et al.[2022]

A review identified 51 smart medication adherence products (smart MAPs) for in-home use, with 38 commercially available, highlighting a diverse range of features to help improve medication adherence.

Most products (75%) included alarms, and 88% provided notifications to patients, indicating that these features can be tailored by clinicians to meet individual patient needs for better adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of features and characteristics of smart medication adherence products. Faisal, S., Ivo, J., Patel, T.[2022]

A pilot study involving 11 patients over 40 years old showed that a training session on using a smartphone medication reminder app (SMRA) increased perceived ease of use and intention to use the app, suggesting that targeted training can enhance user engagement.

Participants felt the app's usefulness could be improved by addressing their specific medication adherence challenges and by fostering a positive perception of app use among family and healthcare providers, indicating that real-world relevance is key to promoting app adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications for Training on Smartphone Medication Reminder App Use by Adults With Chronic Conditions: Pilot Study Applying the Technology Acceptance Model. Park, DY., Goering, EM., Head, KJ., et al.[2020]

A systematic review of 272 medication reminder apps revealed that while many are available, most lack desirable features, with only 18 apps meeting at least 9 out of 17 key criteria for quality.

The review identified that advanced medication reminder apps, which make up 54.8% of the total, offer more features and higher quality ratings compared to basic apps, highlighting the need for users to choose wisely for better medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps. Santo, K., Richtering, SS., Chalmers, J., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Applications on Medication Adherence in Adults with Chronic Diseases: A Systematic Review and Meta-Analysis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Digital Drag and Drop Pillbox: Design and Feasibility of a Skill-based Education Model to Improve Medication Management. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ingestible Biosensors for Real-Time Medical Adherence Monitoring: MyTMed. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Community pharmacy patient perceptions of a pharmacy-initiated mobile technology app to improve adherence. [2015]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Medication Adherence Support: Could Healthcare Providers Recommend Mobile Health Apps? [2022]

7. England pubmed.ncbi.nlm.nih.gov

'Improving smart medication management': an online expert discussion. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A review of features and characteristics of smart medication adherence products. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Implications for Training on Smartphone Medication Reminder App Use by Adults With Chronic Conditions: Pilot Study Applying the Technology Acceptance Model. [2020]

10. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Improve Medication Adherence: A Systematic Stepwise Process to Identify High-Quality Apps. [2022]