Patient Management of Depression Through Technology: a Study of Digitally Enabled Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Patient-provider engagement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient-provider engagement
时间窗: 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.
Patient activation
时间窗: 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.
次要结局
- WHO-5 survey(18 weeks)
- Depression symptoms(18 weeks)
- Cognitive dysfunction(18 weeks)
- Medication changes(18 weeks)
- Health care utilization(18 weeks)
研究者
David Kemp
Medical Director, Behavioral Health Service Line
Advocate Health Care