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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Standard of Care | |
| Mobile App | Active Comparator | Standard of Care and Mobile App |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile App | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 18 weeks |
| Cognitive dysfunction |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term follow health care utilization | This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kemp, MD, MS | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36301599 | Derived | 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. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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This patient reported outcome is assessed by the cognitive dysfunction PDQ-D scale.
| 18 weeks |
| Medication changes | This outcome will be assessed by clinical data on the frequency and types of medication switches. | 18 weeks |
| WHO-5 survey | This patient reported outcome is assessed by the quality of life WHO-5 survey. | 18 weeks |
| Health care utilization | This patient reported outcome is assessed by the healthcare resource utilization and cost RUQ-D survey. | 18 weeks |