Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-24 @ 5:16 PM
Study NCT ID:
NCT03991650
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2019-06-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder
Sponsor:
humanITcare
Organization:
Study Overview
Official Title:
REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMOTE
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: