Pilot Study of Technology Assisted Depression Treatment Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Medication Adherence at Baseline, 6 Weeks and 12 Weeks
研究概览
简要总结
Patients and providers need effective tools to help promote adherence to newly prescribed medications for depression and to determine if this medication is improving depressed mood. This study will test an intervention that uses 1) VA's text messaging program called Annie to help patient's engage in self-management when starting a new medication for depression and 2) My HealtheVet, VA's patient portal, for education and communication with their VA health care team. The goals of this intervention are to improve adherence to depression medication and depressive symptoms in Veterans.
详细描述
Background: There are several known challenges to starting a medication for depression, such as side effects and needing four to six weeks before the effects of the medication may be noticed. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve antidepressant adherence and depression outcomes in Veterans initiating medication to treat depression by using Annie, VA's short messaging services (SMS) application and My HealtheVet, VA's patient portal.
Method: Veterans will be eligible if they are initiating a new antidepressant medication as part of their care at the Iowa City VA primary care or mental health. Veterans will be randomized to one of three groups, usual care or 1 of 2 interventional groups (Annie or Annie plus). Veterans in the intervention groups will 1) receive education about depression and the importance of taking medications as prescribed and 2) receive text messages from "Annie" with information and questions for response. For example, are Veterans taking their medication, is their medication working, and how would they rate their mood. They will also receive weekly reports about their responses to Annie through My HealtheVet, VA's patient portal. In addition, Veterans assigned to Annie Plus will receive a weekly phone call to review progress and to answer any questions. Prior to a participant's scheduled follow-up appointment, a summary of information collected to date via Annie will be made available to the clinical team in the medical record. At the end of the study, participants will be invited to complete a recorded interview about their experiences using the Annie text messaging program and to provide any recommendations for changes. VA providers will also be invited to complete a recorded phone interview about their experience with patients using Annie.
For Veterans randomized to the control condition, research staff will provide education about depression and the importance of taking medications as prescribed. Staff will contact participants in this arm by phone just prior to scheduled follow up visits to discuss any concerns the patient may be experiencing. A sample of Veterans will be asked to complete a recorded interview about their medication management at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with depression
- •Initiating or changing to a new antidepressant medication
- •Cell phone with text messaging capabilities
- •Registered with My HealtheVet
- •Follow-up appointment with their provider in the next 12 weeks
- •Internet access
- •English speaking VA Providers: provide care to a study participant
排除标准
- •Lack of cell phone access/willingness to receive text messages
- •Diagnosis of cognitive disorders, psychotic disorders, bipolar disorder, or active substance abuse.
结局指标
主要结局
Medication Adherence at Baseline, 6 Weeks and 12 Weeks
时间窗: Baseline, 6 and 12 weeks
Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.
次要结局
- Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks(Baseline, 6 and 12 weeks)
- Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks(Baseline, 6 and 12 weeks)