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

NCT ID: NCT03242213

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-20
• Study Completion Date: 2019-09-09

Brief 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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Mobile App

Standard of Care and Mobile App

Group Type: ACTIVE_COMPARATOR

Mobile App

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kemp, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36301599 (View on PubMed)

Other Identifiers

AHC6680

Identifier Type: -

Identifier Source: org_study_id