Substance-Related DisordersFA-O'DIDENCT04659954
Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
A study testing Application O'DIDE in people with Substance-Related Disorders and Personality Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance-Related Disorders, Personality Disorders
- What is being tested?
- Application O'DIDE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2022to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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. With the present study, the investigator 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.
Read the 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.
- Conditions
- Substance-Related Disorders, Personality Disorders
- Being tested
- Application O'DIDE
- Keywords
- E health, Application, Substance use disorders, Personality disorders, Care observance
- Medical subject headings
- Substance-Related Disorders, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application O'DIDEOther
The intervention is the use of an application that aimed to favorize contact between the patient and the care team between the consultations.
| Study group | Role | What they receive |
|---|---|---|
| Application O'DIDE | Experimental | The subjects will use the application O'DIDE during 8 weeks Receives: Other: Application O'DIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of use of the application O'DIDE during 8 weeks
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start7 Jan 2022
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France
- Responsible party
- Sponsor
- Investigators
- Juliette Salles, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659954
- Sponsor's protocol ID
- RC31/20/0367
- Acronym
- FA-O'DIDE
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stocker A, Navarro N, Schmitt L, Delagnes M, Doualle A, Mallard V, Entajan F, Guivarc'h K, Masse P, Chaigneau L, Bonneau B, Lapeyre-Mestre M, Arbus C, Yrondi A, Salles J. Acceptability of "DIDE", a mobile application designed at facilitating care adherence of patients with substance use disorder. Addict Sci Clin Pract. 2024 Oct 15;19(1):72. doi: 10.1186/s13722-024-00500-7.
PubMed 39407238
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of the "O'Dide" Application in People Suffering From an Addiction
- ClinicalTrials.gov ID
- NCT04659954
- Acronym / sponsor ID
- FA-O'DIDE / RC31/20/0367
- Conditions
- Substance-Related Disorders, Personality Disorders
- Keywords
- E health, Application, Substance use disorders, Personality disorders, Care observance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institut de Recherche en Santé Publique, France
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. With the present study, the investigator 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application O'DIDE | Experimental | Other: Application O'DIDEThe subjects will use the application O'DIDE during 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application O'DIDEThe intervention is the use of an application that aimed to favorize contact between the patient and the care team between the consultations. | Other | Application O'DIDE |
Primary outcome
Feasibility of use of the application O'DIDE during 8 weeks
Time frame: 8 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Derived from this study: PubMed 39407238Stocker A, Navarro N, Schmitt L, Delagnes M, Doualle A, Mallard V, Entajan F, Guivarc'h K, Masse P, Chaigneau L, Bonneau B, Lapeyre-Mestre M, Arbus C, Yrondi A, Salles J. Acceptability of "DIDE", a mobile application designed at facilitating care adherence of patients with substance use disorder. Addict Sci Clin Pract. 2024 Oct 15;19(1):72. doi: 10.1186/s13722-024-00500-7.
Related trials for Substance-Related Disorders
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
Alcohol Use Disorder, Addiction
Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliette Salles, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application O'DIDE in people with Substance-Related Disorders and Personality Disorders, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of use of the application O'DIDE during 8 weeks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659954, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.