Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder (REMOTE)

January 24, 2023 updated by: humanITcare

REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospitcal Clínic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There will be a sample n = 60, with 30 healthy control subjects and 30 afflicted experimental subjects.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Mood disorder diagnoses (DSM5).
  • Cognitive deficits that prevent the participation.
  • Active intake of other substances (except for nicotine).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control

n=30 healthy participants will be recruited using social networks and leaflets of information distributed by the research team at the Hospital Cliníc de Barcelona.

The participants will be monitored over the course of one month using the humanITcare app "U-Shine," which will track participant's sociability, device usage, and location frequency using mobile sensors. Participants' data will also be monitored with a FitBit device to track sleep schedules, heart rate, and step count. During the weekly follow-up, they will have to complete the three clinical questionnaires taken at the initial visit.
Behavioral: Monitoring with a device
Participants will be monitored by an App.
Experimental

The recruitment process will be carried out in patients of external consultations and the day hospital of the Addictions Unit at the Hospital Clinic of Barcelona.

n=30 patients with Anxiety and Alcohol Use Disorder.

The participants will be monitored over the course of one month using the humanITcare app "U-Shine," which will track participant's sociability, device usage, and location frequency using mobile sensors. Participants will also be monitored using a FitBit device to track sleep schedules, heart rate, and step count. During the weekly follow-up, they will have to complete the three clinical questionnaires taken at the initial visit.
Behavioral: Monitoring with a device
Participants will be monitored by an App.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-reported Anxiety symptoms assessed with the State-Trait Anxiety Inventory (STAI)
Time Frame: 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.
One month, questionnaire taken 4 times (1/week)
Sleep pattern
Time Frame: One month
Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor
One month
REM sleep time
Time Frame: One month
monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor
One month
Heart Rate
Time Frame: One month
monitoring of heart rate using Fitbit sensor
One month
Step count
Time Frame: One month
Monitoring of daily step count using motion sensor FitBit
One month
Distance travelled
Time Frame: One month
Monitoring of distance travelled using GPS phone
One month
Mobile device usage
Time Frame: One month
Monitoring how often the patient's mobile device is used, determined by tracking the presence of a signal from their device
One month
Sociability (number of incoming an outgoing calls and text messages)
Time Frame: One month
The number of incoming and outgoing calls and text messages will be monitored using the UShine app algorithm
One month
Change in Self-reported Depression symptoms assessed with the Beck's Depression Inventory (BDI-II)
Time Frame: 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.
One month, questionnaire taken 4 times (1/week)
Change in Self-reported Alcohol Abuse Symptoms assesed with the Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: 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.
One month, questionnaire taken 4 times (1/week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability of the mobile application
Time Frame: One month
Ease of usability of the mobile applications by participants will be scaled using the System Usability Scale (SUS). Final scores range from 0-100. A score of 51 or under means the system has serious faults in usability, a score of 68 means the system usability is about average, and a score of 80.3 or higher means the system usability is considered appreciable.
One month
Satisfaction with the application
Time Frame: One month
Participants' satisfaction with the Ushine application will be scaled using the Post-Study Usability Questionnaire (PSSUQ). Scores range from 0-100, 0 being least satisfactory and 100 being the most satisfactory. The PSSUQ has 3 sub-scores representing system usefulness, information quality, and interface quality, also scaled from 0-100. In all score sets, 0 is considered the least satisfactory and 100 is considered the most satisfactory.
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

humanITcare

Collaborators

Hospital Clinic of Barcelona
European Institute of Innovation and Technology

Investigators

  • Principal Investigator: Antoni Gual, MD, Director of Addictions Unit. Hospital Clínic de Barcelona
  • Study Chair: Elsa Caballeria, Clinic Foundation for Biomedical Research
  • Study Chair: Hugo Lopez-Pelayo, MD, Addictions Unit, Hospital Clínic de Barcelona
  • Study Director: Nuria Pastor Hernandez, MSc, humanITcare, FollowHealth SL
  • Study Director: Unai Sanchez Luque, MSc, humanITcare, FollowHealth SL
  • Study Chair: Elizabeth Katayoun Khalilian, humanITcare, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

November 5, 2019

Study Completion (Actual)

November 5, 2019

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (Actual)

June 19, 2019

Study Record Updates

Last Update Posted (Estimate)

January 25, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • humanITcare: Remote

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data sets that underlie results in the final study report will be available for sharing.

IPD Sharing Time Frame

IPD will be available by the estimated date of September 2019, when study results are expected to be published

IPD Sharing Access Criteria

Participants can access their own individual data records, only hospital researchers can access the aggregated data sets.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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