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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile App
Sponsored by
Advocate Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Advocate Christ Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Mobile App

Arm Description

Standard of Care

Standard of Care and Mobile App

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Depression symptoms
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
This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.
Medication changes
This outcome will be assessed by clinical data on the frequency and types of medication switches.
Quality of Life
This patient reported outcome is assessed by the quality of life WHO-5 survey.
Health care utilization
This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.

Full Information

First Posted
July 31, 2017
Last Updated
January 20, 2021
Sponsor
Advocate Health Care
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT03242213
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
January 18, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Advocate Health Care
Collaborators
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
Mobile App
Arm Type
Active Comparator
Arm Description
Standard of Care and Mobile App
Intervention Type
Behavioral
Intervention Name(s)
Mobile App
Intervention Description
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 Measure Information:
Title
Patient activation
Description
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.
Time Frame
18 weeks
Title
Patient-provider engagement
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Depression symptoms
Description
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).
Time Frame
18 weeks
Title
Cognitive dysfunction
Description
This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.
Time Frame
18 weeks
Title
Medication changes
Description
This outcome will be assessed by clinical data on the frequency and types of medication switches.
Time Frame
18 weeks
Title
Quality of Life
Description
This patient reported outcome is assessed by the quality of life WHO-5 survey.
Time Frame
18 weeks
Title
Health care utilization
Description
This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.
Time Frame
18 weeks
Other Pre-specified Outcome Measures:
Title
Long-term follow health care utilization
Description
This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kemp, MD, MS
Organizational Affiliation
Advocate Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36301599
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.
Results Reference
derived

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

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