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Trial record 20 of 33 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND BDI | ( Map: Spain )

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

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ClinicalTrials.gov Identifier: NCT03991650
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborators:
Hospital Clinic of Barcelona
European Institute of Innovation and Technology
Information provided by (Responsible Party):
humanITcare

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.

Condition or disease Intervention/treatment
Anxiety Disorders Alcohol Use Disorder Depressive Disorder Behavioral: Monitoring with a device

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: REMOTE: Monitoring Telemedicine Platform in Patients With Anxiety Symptoms and Alcohol Use Disorder: Smartphone and Wearable Sensors
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 5, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Anxiety

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.




Primary Outcome Measures :
  1. 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.

  2. Sleep pattern [ Time Frame: One month ]
    Monitoring of circadian rhythm using a motion sensor Fitbit and cardiac activity sensor

  3. REM sleep time [ Time Frame: One month ]
    monitoring of REM sleep patterns using a motion sensor Fitbit and cardiac activity sensor

  4. Heart Rate [ Time Frame: One month ]
    monitoring of heart rate using Fitbit sensor

  5. Step count [ Time Frame: One month ]
    Monitoring of daily step count using motion sensor FitBit

  6. Distance travelled [ Time Frame: One month ]
    Monitoring of distance travelled using GPS phone

  7. 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

  8. 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

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
There will be a sample n = 60, with 30 healthy control subjects and 30 afflicted experimental subjects.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991650


Contacts
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Contact: Nuria Pastor Hernandez, MSc +34 628994983 nuria.pastor@humanitcare.com
Contact: Unai Sánchez Luque, MSc +34 620248183 unai.sanchez@humanitcare.com

Locations
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Spain
Hospitcal Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Sponsors and Collaborators
humanITcare
Hospital Clinic of Barcelona
European Institute of Innovation and Technology
Investigators
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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

Additional Information:
Publications:
Ghandeharioun, A., Fedor, S., Sangermano, L., Ionescu, D., Alpert, J., Dale, C., ... & Picard, R. (2017, October). Objective assessment of depressive symptoms with machine learning and wearable sensors data. In Affective Computing and Intelligent Interaction (ACII), 2017 Seventh International Conference on (pp. 325-332). IEEE.

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Responsible Party: humanITcare
ClinicalTrials.gov Identifier: NCT03991650     History of Changes
Other Study ID Numbers: humanITcare: Remote
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data sets that underlie results in the final study report will be available for sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be available by the estimated date of September 2019, when study results are expected to be published
Access Criteria: Participants can access their own individual data records, only hospital researchers can access the aggregated data sets.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by humanITcare:
wearable
sensor
anxiety
monitoring
ehealth
Alcohol Use Disorder
depression
Additional relevant MeSH terms:
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Depressive Disorder
Drinking Behavior
Disease
Alcoholism
Anxiety Disorders
Alcohol Drinking
Pathologic Processes
Mental Disorders
Mood Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs