PAUSE: Sick Day Medication Management Mobile App Study

Starting soon · Not applicable

Conditions studied: Chronic Condition, Adverse Event

In brief

Diabetes, heart disease and kidney disease have high morbidity and costs of care. Medications used to treat these conditions are effective. Yet, some have the risk of preventable adverse events when people are sick with the flu or stomach bug. These events include low blood sugar and acute kidney injury which can lead to extended hospital stays or death. Sick day medication guidance (SDMG) recommends stopping these medications temporarily when sick and restarted after symptoms subside. Unfortunately, many patients are not aware of these recommendations or find them hard to follow. The investigator's previous research has shown that there is a lack of SDMG education and patient resources. Research on the development, implementation, usability and efficacy of these resources is also limited. In developing a SDMG tool, the investigators surveyed patients who expressed interest in an electronic health (eHealth) tool. As a result, the PAUSE App provides a timely and innovative way to provide continuity of care to patients that is linked to each patients' unique pharmacy record. In the present pilot randomized control trial, the investigators will examine the outcomes of the PAUSE Initiative consisting of the PAUSE App and a SDMG educational handout. Approximately 16 Loblaw/Shoppers Drug Mart pharmacies across Alberta will take part. Patients of these pharmacies who take high-risk medications will be invited to participate. Each pharmacy will be randomized to provide their patients usual care (i.e. SDMG handout) or the intervention (i.e., PAUSE App + handout). Approximately 320 participants (20 per pharmacy) are expected to be recruited. The expected trial length is 9 months from recruitment to analysis. A simulated 'sick day' survey will be used to assess the fidelity and efficacy of the PAUSE Initiative. Feasibility of the study processes (i.e., recruitment, onboarding) will be assessed to inform a full-scale trial. The usability and acceptability of the PAUSE App will also be investigated. Pharmacists and participants will complete questionnaires and qualitative interviews to assess these outcomes. Additionally, PAUSE App user metrics will be collected. All participants will receive an honorarium for their time.

Key facts

Study ID

NCT06433414

Run by

University of Alberta

People needed

320

Starts

2027-01-01

Expected to finish

2027-12-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age and able to provide informed consent
• be able to communicate (read, write, and speak) in English
• have access to a smartphone/tablet with an Internet connection
• be willing and able to download and use the PC Health app for the duration of the study
• currently be taking 2 or more medications from the following classes: renin-angiotensin-aldosterone system (RAAS) antagonists, diuretics, oral NSAIDs, metformin, or 1 or more medications from the following classes: insulin, sulfonylureas, meglitinides, SGLT2 inhibitors.

You may not qualify if…

• fail to meet the inclusion criteria
• have kidney failure requiring maintenance dialysis
• have had an organ transplant
• are pregnant
• receive qualifying medications in a blister pack or sachet
• do not primarily manage their own medications and condition (i.e., receive home care, in a rehabilitation or medical respite facility)
• cannot use the PC Health app independently
• previously participated in studies that led to the development of the PAUSE App (including the PAUSE study usability testing or needs assessment focus groups)

Full record on ClinicalTrials.gov

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