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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

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 8, 2017
Last Update Posted Date January 25, 2019
Actual Study Start Date  ICMJE July 20, 2017
Actual Primary Completion Date January 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
  • 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).
  • Cognitive dysfunction [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.
  • Medication changes [ Time Frame: 18 weeks ]
    This outcome will be assessed by clinical data on the frequency and types of medication switches.
  • Quality of Life [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the quality of life WHO-5 survey.
  • Health care utilization [ Time Frame: 18 weeks ]
    This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 3, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
Official Title  ICMJE Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE 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.
Study Arms  ICMJE
  • No Intervention: Usual Care
    Standard of Care
  • Active Comparator: Mobile App
    Standard of Care and Mobile App
    Intervention: Behavioral: Mobile App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 3, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2019
Actual Primary Completion Date January 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03242213
Other Study ID Numbers  ICMJE 6680
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David Kemp, Advocate Health Care
Study Sponsor  ICMJE Advocate Health Care
Collaborators  ICMJE Takeda
Investigators  ICMJE
Principal Investigator: David Kemp, MD, MS Advocate Health Care
PRS Account Advocate Health Care
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP