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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242213
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
David Kemp, Advocate Health 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Mobile App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : January 18, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Patient activation [ Time Frame: 18 weeks ]
    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.

  2. Patient-provider engagement [ Time Frame: 18 weeks ]
    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.


Secondary Outcome Measures :
  1. Depression symptoms [ Time Frame: 18 weeks ]
    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).

  2. Cognitive dysfunction [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.

  3. Medication changes [ Time Frame: 18 weeks ]
    This outcome will be assessed by clinical data on the frequency and types of medication switches.

  4. Quality of Life [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the quality of life WHO-5 survey.

  5. Health care utilization [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03242213


Locations
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United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
Sponsors and Collaborators
Advocate Health Care
Takeda
Investigators
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Principal Investigator: David Kemp, MD, MS Advocate Health Care
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Responsible Party: David Kemp, Medical Director, Behavioral Health Service Line, Advocate Health Care
ClinicalTrials.gov Identifier: NCT03242213    
Other Study ID Numbers: 6680
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders