Clinical trial NCT03242213: Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Official title: Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2017-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient activation
timeFrame: 18 weeks
measure: Patient-provider engagement
timeFrame: 18 weeks
Secondary outcomes:
measure: Depression symptoms
timeFrame: 18 weeks
measure: Cognitive dysfunction
timeFrame: 18 weeks
measure: Medication changes
timeFrame: 18 weeks
measure: WHO-5 survey
timeFrame: 18 weeks
measure: Health care utilization
timeFrame: 18 weeks
Other outcomes:
measure: Long-term follow health care utilization
timeFrame: 1 year
Locations:
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Kemp, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.