Status:
COMPLETED
Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Takeda
Lundbeck LLC
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study was conducted to understand the use of a mobile app (titled Pathway) to help patients track depression symptoms, medications, side effects, and goals in addition to the usual care with thei...
Detailed Description
A pre- and post- study design was utilized to assess the impact of implementing the Pathway Platform in the primary care setting. The Pathway Platform consists of a mobile app for patients and a care ...
Eligibility Criteria
Inclusion
- Diagnosis with major depressive disorder or reference to "clinical depression" in patient charts.
- Recently prescribed monotherapy antidepressant medication (defined as new start, medication switch, or dose change in the past 3 months.)
- Patients with inadequate response or tolerability concerns determined based on A PHQ-2 score of 3 or greater or a PHQ-9 score of 5 or more, recorded in medical records in the past 6 weeks or during screening,
- Able and willing to provide informed consent
- Able to use the Pathway Platform based on clinician's judgment, e.g. owns an iPhone version 5 or later or smartphones with Android operating systems, have an active data plan or regular WiFi access
Exclusion
- Missing PHQ-2 score in the past 6 weeks and/or unable to perform PHQ-2 at index visit
- Diagnosis with bipolar depression, schizophrenia, and/or schizoaffective disorder
- Patient no longer under primary care for depression and has transitioned to a psychiatric care team (i.e., Psychiatrist, Advance Practice Psychiatric Nurse, Psychiatric Nurse Practitioner, Psychiatric Physician Assistant).
- Lack of functional English literacy (indicated by primary language in electronic medical record).
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04891224
Start Date
February 19 2021
End Date
January 30 2023
Last Update
March 24 2025
Active Locations (1)
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1
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453