NCT03242213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2019

Completed
Last Updated

October 4, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

July 31, 2017

Last Update Submit

October 2, 2024

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Depression symptoms

    18 weeks

  • Cognitive dysfunction

    18 weeks

  • Medication changes

    18 weeks

  • WHO-5 survey

    18 weeks

  • Health care utilization

    18 weeks

Other Outcomes (1)

  • Long-term follow health care utilization

    1 year

Study Arms (2)

Usual Care

NO INTERVENTION

Standard of Care

Mobile App

ACTIVE COMPARATOR

Standard of Care and Mobile App

Behavioral: Mobile App

Interventions

Mobile AppBEHAVIORAL

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.

Mobile App

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Related Publications (1)

  • 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.

    PMID: 36301599DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • David Kemp, MD, MS

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 8, 2017

Study Start

July 20, 2017

Primary Completion

January 18, 2019

Study Completion

September 9, 2019

Last Updated

October 4, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)