REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI)
研究概览
简要总结
The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of remote collected data.
详细描述
The objective of this study is to analyze the physiological patterns of two groups of patients, one control and one with anxiety disorder and alcoholic abuse disorder using sensor data from mobile devices and wearables. This data, collected by sensors, will be compared to the data presented by three clinical questionnaires: State-trait Anxiety Inventory (STAI), the Alcohol Use Disorders Identification Test (AUDIT), and the Beck's Depression Inventory (BDI-II) in order to determine the feasibility of using remote collected data in routine clinical practice. Furthermore, patient satisfaction with the app will be evaluated after the data collection phase.
This is a unicentric, case-controlled, longitudinal, evaluational, national study with two groups, one control of healthy individuals without symptoms of anxiety or depression, and another experimental group in which participants fulfill the given selection criteria for the trial. There are a total of 60 participants split evenly between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years of age.
- •Alcohol use disorder (DSM 5) as main substance.
- •Anxiety (STAI > percentile 33) and, if depressive symptoms, not clinically relevant as to accomplish DSM5 diagnostic criteria for mood disorders (major depressive disorder, bipolar disorder...).
- •Having a mobile phone compatible with Android.
- •Sign informed consent.
排除标准
- •Mood disorder diagnoses (DSM5).
- •Cognitive deficits that prevent the participation.
- •Active intake of other substances (except for nicotine).
结局指标
主要结局
Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI)
时间窗: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive STAI scores ranging from 0-60, 0 being lowest amount of symptoms, and 60 being the greatest amount of symptoms, which are then transformed into percentiles according to age and sex.
Sleep pattern
时间窗: One month
Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor
REM sleep time
时间窗: One month
monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor
Heart Rate
时间窗: One month
monitoring of heart rate using Fitbit sensor
Step count
时间窗: One month
Monitoring of daily step count using motion sensor FitBit
Distance travelled
时间窗: One month
Monitoring of distance travelled using GPS phone
Mobile device usage
时间窗: One month
Monitoring how often the patient's mobile device is used, determined by tracking the presence of a signal from their device
Sociability (number of incoming an outgoing calls and text messages)
时间窗: One month
The number of incoming and outgoing calls and text messages will be monitored using the UShine app algorithm
Change in Self-reported Depression symptoms assessed with the Beck's Depression Inventory (BDI-II)
时间窗: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive BDI-II scores ranging from 1-63, with a score of 0-13 indicating minimal depression, 14-19 indicating mild depression, 20-28 indicating moderate depression, and 29-63 indicating severe depression.
Change in Self-reported Alcohol Abuse Symptoms assesed with the Alcohol Use Disorders Identification Test (AUDIT)
时间窗: One month, questionnaire taken 4 times (1/week)
Taken through the application "Ushine". Participants receive AUDIT scores ranging from 0-40. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.
次要结局
- Usability of the mobile application(One month)
- Satisfaction with the application(One month)