Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction (FA-O'DIDE)
Primary Purpose
Substance-Related Disorders, Personality Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Application O'DIDE
Sponsored by
About this trial
This is an interventional other trial for Substance-Related Disorders focused on measuring E health, Application, Substance use disorders, Personality disorders, Care observance
Eligibility Criteria
Inclusion Criteria:
- Suffering from any type of addiction, with an active addiction requiring weekly monitoring of consumption
- Possessing an Android smartphone or having access to an Android smartphone and having access to an internet connection
- Able to read and understand French
- Affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
- Patient with cognitive or psychiatric disorders that may affect their ability to consent
- Participation in another protocol involving a modification of the treatment for addiction
- Person under legal protection, guardianship or curatorship
- Known or suspected pregnancy
Sites / Locations
- University hospital of Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Application O'DIDE
Arm Description
The subjects will use the application O'DIDE during 8 weeks
Outcomes
Primary Outcome Measures
Feasibility of the application O'DIDE
Percentage of patients who logged on at least once a week to the application during the 8 weeks of availability of the O'DIDE application
Secondary Outcome Measures
Full Information
NCT ID
NCT04659954
First Posted
December 2, 2020
Last Updated
December 2, 2020
Sponsor
University Hospital, Toulouse
Collaborators
Institut de Recherche en Santé Publique, France
1. Study Identification
Unique Protocol Identification Number
NCT04659954
Brief Title
Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
Acronym
FA-O'DIDE
Official Title
Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Institut de Recherche en Santé Publique, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Substance Use Disorders (SUD) are associated with cognitive schemas that lead to care attrition and mistrust towards care. Considering this within SUD management, it is important to establish a confident relation between the patient and the care team to favorize acre observance. However, it demands an important availability of the healthcare team, allowing for frequent interactions at all times, including at night and during days off. We postulated that an application called Ô DIDE for Digital Interaction for Detoxification Engagement, that aims to help the caregivers maintaining a link with the patient in order to facilitate confidence in the relationship, could favorize care observance especially consumption report.
Detailed Description
The present research aims to assess the feasibility of the "Ô DIDE" application after 8 weeks of use by patients treated for a disorder related to substance use at the Toulouse University Hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Personality Disorders
Keywords
E health, Application, Substance use disorders, Personality disorders, Care observance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Application O'DIDE
Arm Type
Experimental
Arm Description
The subjects will use the application O'DIDE during 8 weeks
Intervention Type
Other
Intervention Name(s)
Application O'DIDE
Intervention Description
The intervention is the use of an application that aimed to favorize contact between the patient and the care team between the consultations.
Primary Outcome Measure Information:
Title
Feasibility of the application O'DIDE
Description
Percentage of patients who logged on at least once a week to the application during the 8 weeks of availability of the O'DIDE application
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suffering from any type of addiction, with an active addiction requiring weekly monitoring of consumption
Possessing an Android smartphone or having access to an Android smartphone and having access to an internet connection
Able to read and understand French
Affiliated or beneficiary of a social security scheme.
Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
Patient with cognitive or psychiatric disorders that may affect their ability to consent
Participation in another protocol involving a modification of the treatment for addiction
Person under legal protection, guardianship or curatorship
Known or suspected pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliette Salles, MD
Phone
33-561777307
Email
salles.j@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliette Salles, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliette SALLES, MD
First Name & Middle Initial & Last Name & Degree
Juliette SALLES, MD
First Name & Middle Initial & Last Name & Degree
Nicolas NAVARRO, MD
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
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