Table 6 Application requirements
Requirement | Description |
|---|---|
Application purpose | This medication adherence service will aim at assisting targeted patient populations remain compliant with medication regimens. |
As a first step, the service provider will conduct a pilot study to better understand the impact of smart pill adherence tracking devices on medication compliance levels. The following questions will be addressed: | |
1. What are the relevant adherence rates among the 3 study arms: (a) patient uses no device (e.g., conventional plastic bottle/manual adherence tracking); (b) patient uses a pill adherence tracking device without any associated follow-up intervention in the event of non-adherence; and (c) patient uses a pill adherence tracking device with a follow-up intervention in the event of non-adherence. 2. What are the (a) usability and (b) technical/ installation/operational issues associated with the chosen pill adherence tracking device in a home setting? | |
Cohort profile | Hypertension patients >65 years taking tablets 1x / day. |
Total number of patients across the 3 groups yet to be defined. | |
Ethnographic analysis | Given that hypertension patients are typically 60 years or older, factors related to ageing would have to be considered (i.e. poorer levels of sight, hearing, and dexterity through the fingers) and will inform decisions regarding device selection. |
Setting | Home |
Geographical location | Dublin, Ireland |
Timeframe | 6 Months |
Deployment duration | Patients will be asked to track their medication adherence for 2 months. |
What data need to be collected (via device)? | Electronic Medication Compliance Data (timestamp). |
What type of device is required? | Smart pill adherence tracking device. |
What level of accuracy is required? | Medical standard device—device classification (e.g., class I, class II) to be determined as part of the device evaluation process. |
Are there any ethical issues to be considered? | None of significance |
Standards and regulatory factors to be considered | Compliant with EU standards (CE marking and EU Data Protection Directive). |
Hygiene considerations | Devices used require cleaning on return. |
Human factors to be considered | Patient: ease of use, reliability, durability. |
Service provision: ease of installation. | |
Device: must be portable (e.g., on vacation) and allow offline use. | |
Technical factors to be considered | Device manufacturer must provide a mechanism for the data to be pulled from their servers (this will allow the service provider to use their own application instead of manufacturer’s app). |
Must allow real-time access to monitoring data by other services. | |
Must provide an optional follow-up intervention in the event of non-adherence (group (b): won’t use this feature; group (c): will). | |
Budget | To be determined as part of the device evaluation process. |
In-house expertise available | Design and engineering staff |
