Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
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|ClinicalTrials.gov Identifier: NCT03242213|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2017
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Behavioral: Mobile App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|United States, Illinois|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|Principal Investigator:||David Kemp, MD, MS||Advocate Health Care|