Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement

The current randomized controlled trial is a pilot study that will assess the effectiveness and feasibility of a mobile phone application intervention. The objective is to determine whether the use of a mobile health application for patient self-management of depression improves patient-provider engagement for patients diagnosed with major depressive disorder.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Mobile App

Detailed Description

This pilot study will be a randomized, real-world effectiveness study. Patients diagnosed with major depressive disorder starting a new prescription for an antidepressant monotherapy will be eligible for participation. The study will enroll 40 patients (20 in an observational arm of usual care and 20 with access to a mobile health application). No intervention will occur in the usual care arm. The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression. Patient reported outcomes and clinical data will be collected at baseline and at study primary endpoint (18 weeks) to assess changes over time and between groups for: patient-provider engagement, disease severity, quality of life, employment productivity, cognitive function, resource utilization, and medication adherence. Additionally, resource utilization will be assessed at the one year time point. A Student's t test, if allowed for by the data distribution, will be used to assess between group differences in patient reported outcome scales assessing patient-provider engagement.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Christ Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 70
• Ability to consent and participate in study (technical requirements for app: iPhone version 5 or later, active data plan or regular WiFi access)
• Diagnosis with major depressive disorder
• PHQ-9 score greater than 5 at baseline
• Recent (0-14 days) start on monotherapy depression medication (either new prescription or a change from a previous medication)
• Outpatient care provided by participating Advocate Medical Group clinics

Exclusion Criteria:

• Diagnosis with major psychiatric disorder (e.g. bipolar disorder, manic depressive disorder)
• Contraindications to use of depression medications
• Patients with treatment resistant depression [defined as patients who have not responded to two or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in the current depressive episode]
• Considered at imminent risk for hospitalization due to severe depression in the opinion of the treating physician
• History of hospitalization due to major depressive disorder in prior 3 months
• Significant risk of suicide according to the treating physician's clinical judgment or previous suicide attempt in prior 6 months
• History of response only to combination or augmentation therapy in current depressive episode
• Receipt of any investigational compound in prior 30 days (or five half-lives, whichever is longer)
• Current participation in another clinical study
• Lack of functional English literacy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Standard of Care
Active Comparator: Mobile App; Standard of Care and Mobile App	Behavioral: Mobile App; The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient activation	This will be assessed by the Patient Activation Measure, a validated scale that measures patient knowledge, skills and confidence in disease self-management in the primary care setting.	18 weeks
Patient-provider engagement	This will be assessed by the Patient-Provider Engagement Scale (PPES-7), an instrument developed for this study to measure patient knowledge, communication, and interaction with their provider specific to depression management.	18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms	This patient reported outcome is assessed by the clinical depression severity. PHQ-9 scale, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).	18 weeks
Cognitive dysfunction	This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.	18 weeks
Medication changes	This outcome will be assessed by clinical data on the frequency and types of medication switches.	18 weeks
Health care utilization	This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.	18 weeks
WHO-5 survey	This patient reported outcome is assessed by the quality of life WHO-5 survey.	18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term follow health care utilization	This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.	1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Takeda
• Investigators: Principal Investigator: David Kemp, MD, MS, Advocate Health Care

Publications and helpful links

General Publications

• McCue M, Blair C, Fehnert B, King J, Cormack F, Sarkey S, Eramo A, Kabir C, Khatib R, Kemp D. Mobile App to Enhance Patient Activation and Patient-Provider Communication in Major Depressive Disorder Management: Collaborative, Randomized Controlled Pilot Study. JMIR Form Res. 2022 Oct 27;6(10):e34923. doi: 10.2196/34923.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): September 9, 2019

Study Registration Dates

• First Submitted: July 31, 2017
• First Submitted That Met QC Criteria: August 3, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: AHC6680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No