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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242213
• Other study ID #: 6680
• Status: Completed
• Phase: N/A
• Start date: July 20, 2017
• Est. completion date: September 9, 2019

Study information

• Verified date: January 2021
• Source: Advocate Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 9, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Advocate Christ Medical Center	Oak Lawn	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Advocate Health Care	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term follow health care utilization	This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.	1 year
Primary	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
Primary	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	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
Secondary	Cognitive dysfunction	This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.	18 weeks
Secondary	Medication changes	This outcome will be assessed by clinical data on the frequency and types of medication switches.	18 weeks
Secondary	Quality of Life	This patient reported outcome is assessed by the quality of life WHO-5 survey.	18 weeks
Secondary	Health care utilization	This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.	18 weeks