Use of a Digitally Enabled App With Clinical Team Interface in the Management of Depression

NCT04891224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2025-03-24

Study results available
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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 their doctor. Investigators compared the effect of the app over 6 months and examine whether the app can increase engagement between patients and their doctor and help in the management of illnesses as patients started a new treatment for depression. The investigators hoped that using an app to facilitate management of depression symptoms, medication use, and side effects help patients and their providers understand their response to medications and lead to better response and improvements in depression.

Conditions

Interventions

OTHER

Pathway Platform mobile app

The pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13\[PAM-13\], CollaboRATE, and Work and Social Adjustment Scale \[WSAS\]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY
  • Lundbeck LLC

    collaborator INDUSTRY
  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • David Kemp, MD · Advocate Medical Group

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2023-01-30
Completion
2023-01-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04891224 on ClinicalTrials.gov