Mobile App in Addiction - Clinical Trial for Addiction | NCT04133688

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

ASC

About this trial

This is an interventional supportive care trial for Addiction focused on measuring mobile app, pilot study, addiction, sleep, ePRO

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Teenagers or young adults from 12 to 18 years old (included)
Consultant for addiction to cannabis and / or tobacco and / or alcohol and / or screen
Treated within the Functional Unit of addictology
For minors, after parental consent

Exclusion Criteria:

-

Sites / Locations

Robert Debre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile application (ASC)

Paper diary

Arm Description

mobile app / devise

paper diary

Outcomes

Primary Outcome Measures

Number of days filled for sleep and consumptions, usable by the doctor on the day of the consultation / after 15 days of self-evaluation required by the treatment

Secondary Outcome Measures

Full Information

NCT ID

NCT04133688

First Posted

October 18, 2019

Last Updated

October 15, 2021

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04133688

Brief Title

Mobile App in Addiction

Acronym

ASC-Val

Official Title

A Mobile App for the Self Quantification of Sleep and Behaviors : a Pilot Study With Teenagers and Young Adults

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

October 30, 2019 (Actual)

Primary Completion Date

October 6, 2020 (Actual)

Study Completion Date

October 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

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

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

Detailed Description

The sleep and behavior agendas are today very largely underused while they can be of a considerable contribution in the follow-up of the patients and the reinforcement of the therapeutic alliance. In the management of addictions, sleep disorders are a major comorbidity, these two components maintain indeed complex links: it was highlighted a bidirectional relationship between the effect of the consumption of addictive substances on sleep and conversely, the effect of sleep disorders on the consumption of products, the same is true for overexposure to screens.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Addiction

Keywords

mobile app, pilot study, addiction, sleep, ePRO

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile application (ASC)

Arm Type

Experimental

Arm Description

mobile app / devise

Arm Title

Paper diary

Arm Type

Active Comparator

Arm Description

paper diary

Intervention Type

Device

Intervention Name(s)

ASC

Other Intervention Name(s)

mobile application

Intervention Description

mobile app

Primary Outcome Measure Information:

Title

Number of days filled for sleep and consumptions, usable by the doctor on the day of the consultation / after 15 days of self-evaluation required by the treatment

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Teenagers or young adults from 12 to 18 years old (included) Consultant for addiction to cannabis and / or tobacco and / or alcohol and / or screen Treated within the Functional Unit of addictology For minors, after parental consent Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Benjamin Pitrat, MD

Organizational Affiliation

APHP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Robert Debre Hospital

City

Paris

ZIP/Postal Code

75019

Country

France

Mobile App in Addiction (ASC-Val)

Addiction

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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