Accepted for/Published in: JMIR Formative Research
Date Submitted: Nov 12, 2021
Open Peer Review Period: Nov 12, 2021 - Jan 7, 2022
Date Accepted: Jun 27, 2022
(closed for review but you can still tweet)
Assessment of Digitally Enabled Engagement in Major Depressive Disorder Within a Large Health System: A Collaborative, Randomized Controlled Pilot Study
ABSTRACT
Background:
Enhanced patient-provider engagement can improve patient health outcomes in chronic conditions, including major depressive disorder (MDD).
Objective:
This study evaluated the impact of a digitally enabled care Pathway mobile app designed to improve patient-provider engagement in patients with MDD. Patients used a mobile interface to assess treatment progress and share this information with primary care providers (PCPs).
Methods:
In this 52-week, real-world effectiveness and feasibility study conducted in primary care clinics, 40 patients with MDD and recently prescribed antidepressant monotherapy were randomized to use of a mobile app with usual care (n=20) or usual care alone (n=20). Patients in the app arm engaged with the app daily for 18 weeks; a report was generated at 6-week intervals and shared with PCPs to facilitate shared treatment decision-making discussions. Patients discontinued the app at week 18 and were followed through year 1. Coprimary outcome measures included change from baseline in PAM-13 and PPES-7 at week 18. Additional outcome measures included depression severity (PHQ-9), cognitive symptoms (PDQ-D5), medication switches and adherence, quality of life (WHO-5), satisfaction with patient and provider engagement, and engagement with and use of the mobile app. Cognitive symptoms (PDQ-D5) and patient and provider satisfaction were evaluated at Week 18 only; all other endpoints were assessed at weeks 18 and 52.
Results:
Of the 40 patients included in the study (83.8% female, mean age 36.4 years), all had moderate to moderately severe depression. Improvements in PAM-13 and PHQ-9 scores were observed in both arms. Increases in PAM-13 scores from baseline to 18 weeks were numerically greater in the app arm than in the usual-care arm (10.5 [SD 13.2] vs 8.8 [SD 9.4]; P=.65). At 52 weeks, differences in PAM-13 scores from baseline demonstrated statistically significant greater improvements in the app arm than in the usual-care arm (20.2 [SD 17.7] vs 1.6 [SD 14.2]; P=.04). Compared with baseline, PHQ-9 scores decreased in both the app arm and the usual-care arm at 18 weeks (7.8 [SD 6.7] vs 7.0 [SD 6.5]; P=.73) and 52 weeks (9.5 [SD 4.0] vs 4.7 [SD 6.0]; P=.07). Improvements in PPES-7 and WHO-5 scores were observed in both arms at 18 weeks and were sustained through 52 weeks in the app arm. Improvements in WHO-5 scores at 52 weeks were significantly greater in the app arm than in the usual-care arm (41.5 vs 20.0; P=.02).
Conclusions:
Patients with MDD will engage with a mobile app designed to track treatment and disease progression, and PCPs will use data generated as part of their assessment to track and inform clinical care. Study results suggest an app-enabled clinical care pathway may enhance patient activation and benefit MDD management. Clinical Trial: ClinicalTrials.gov NCT03242213
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