Development and Implementation of a Behavioral Digital Therapeutic Designed to Support, Educate, Screen and Remotely Monitor Patients with Chronic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- PROMIS Pain Interference Scale - Short Form 6b
研究概览
简要总结
The investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
详细描述
This study will evaluate the existing 2Morrow Chronic Pain Self-Management Program, in the form of a mobile app, as a digital therapeutic for improving patients' pain self management and function who suffer from chronic pain. Specifically, the investigators will conduct a 2-arm randomized control feasibility study to evaluate: 1) the feasibility of using the mobile app and an optional activity tracker, 2) the feasibility of conducting a 2-arm trial, and 3) estimate the effect size for planning for a larger efficacy trial based on our primary outcomes. The intervention arm will test a mobile app that aims to help people reduce pain interference who have chronic pain, as well as mental health issues with depression and anxiety. Participants in the intervention arm will also have the option to sense health data with a tracker that integrates with the app, which will inform the feasibility of this feature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=18 years old
- •at least one ICD pain related diagnosis noted in the electronic health record (EHR)
- •at least 2 visits in a primary care clinic with at least one in the last 12 months
- •willing to use a mobile app in English
- •T-score for the PROMIS brief pain inventory of >= 55
- •access to a smartphone
- •willing to download and use a mobile app daily
排除标准
- •current cancer related diagnosis (to exclude cancer related chronic pain)
- •plans for surgery in next 3 months
- •currently receiving hospice care
结局指标
主要结局
PROMIS Pain Interference Scale - Short Form 6b
时间窗: will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm)
Brief survey of patient's perceived pain interference in their ability to function; scores are normed on a T-score with 50 as the mean, 10 as the standard deviation, and higher scores are worse
次要结局
- Patient Health Questionnaire 9 (PHQ-9)(will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm))
- Generalized Anxiety Disorder 7 (GAD-7)(will be measured at baseline, 1 month, 3 months, and 6 months after enrollment (and start of intervention in the intervention arm))
研究者
Kari Stephens
Professor of Family Medicine
University of Washington