Table 1.
Overview of human factors studies
| Study | Participants | Device/interface tested | Onboarding | Changes resulting from the study |
|---|---|---|---|---|
| Patient interface studies | ||||
| Formative 1 December 2013 |
Patients N=10 (2 BP-I, 4 MDD, 4 SZ) |
Wearable sensor version RP4, DMS version 1.3, preliminary labeling |
No in-person assistance | New wearable sensor design implemented, mandatory in-app training video generated |
| Formative 2 February 2014 |
Patients N=7 (3 BP-I, 2 MDD, 2 SZ) |
Wearable sensor version DW5, DMS version 1.5, preliminary labeling |
No in-person assistance, full-length, simulated in-app video | Packaging, medication reminder, and notification tile redesigned |
| Formative 3 December 2014 |
Patients N=36 (18 SZ, 8 MDD, 10 BP-I) |
Wearable sensor version DW5, DMS version 1.5.2 |
In-app videos during onboarding; HCP-assisted onboarding for 18 participants followed by independent use | Modifications to pill tiles and reminders, wearable sensor status tiles and patch application videos, and language and visuals of onboarding videos |
| Formative 4 March 2015 |
Patients N=36 (12 SZ, 10 BP-I, 14 MDD) |
Wearable sensor version DW5, DMS version 1.5.2, draft labeling |
In-app video during onboarding; HCP-assisted onboarding for 17 participants | Introduction of quick start guide, elimination of pill reminder functionality, modification to wearable sensor tiles, and language of onboarding videos |
| Formative 5 a, b, c July 2016–October 2016 |
Patients N=30 (15 SZ, 9 BP-I, 6 MDD) |
Wearable sensor version DW5, DMS version 2.0, draft labeling (including draft quick start guide) |
In-app videos during onboarding | Modifications to onboarding flow, daily summary tile, wearable sensor icons, and introduction of quick start guide |
| Formative 6 October 2016 |
Patients N=10 (6 SZ, 1 BP-I, 3 MDD) |
Wearable sensor version DW5, DMS version 2.0, draft labeling (including draft quick start guide) |
In-app videos during onboarding | Updates to onboarding videos related to wearable sensor issues and the daily summary tile; changes to increase legibility of text in the system |
| Patient validation 2017 | Patients N=35 (11 SZ, 12 BP-I, 12 MDD) |
Wearable sensor version DW5, DMS version 2.0, draft labeling |
In-app videos during onboarding; HCP-assisted onboarding for 17 patients | |
| HCP/caregiver studies | ||||
| Formative March 2014 |
HCPs and caregivers N=11 (6 HCPs, 5 caregivers) |
HCP dashboard, caregiver dashboard | No in-person assistance, full-length, simulated dashboard video for caregivers | Feedback on structuring of assisted onboarding |
| Validation February 2015 |
HCPs and caregivers N=33 (17 HCPs, 16 caregivers) |
HCP dashboard, caregiver dashboard | No assistance | |
Abbreviations: BP-I, bipolar I disorder; DMS, digital medicine system; HCP, health care provider; MDD, major depressive disorder; SZ, schizophrenia.