Back to resultsJoint Effort Study (JointEffort)
Primary Purpose
Cannabis Use
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Joint Effort
Brief normative feedback and standard information
Sponsored by
About this trial
This is an interventional supportive care trial for Cannabis Use
Eligibility Criteria
Inclusion Criteria:
- active cannabis user (i.e., having used cannabis at least once in the past month)
- able to understand French
- own an iPhone (running on iOS 13 or higher).
Sites / Locations
- Université de Montréal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Joint Effort (mobile application)
Brief normative feedback and standard information
Arm Description
The Joint Effort mobile application aims to support young adults into taking action on their cannabis use. Based on the Theory of Planned Behaviour, the content focuses on intention, attitude and perceived behavioral control. Various intervention methods and strategies are used to address these determinants (e.g., personalized feedback, persuasive communication, self-observation and activation of intention). The objectives includes: to allow the individual to become aware (or more aware) of their cannabis use, to support the individual's decision-making process of taking action on their cannabis use, to guide and support the establishment and sustainability of an action plan. An optional logbook-type feature (weekly journal of cannabis use) allows personalized monitoring and data collection throughout the course of the intervention.
The comparator is composed of a a brief normative feedback regarding last month frequency of cannabis use and basic reliable non personalized information on lower-risk cannabis use (official public websites).
Outcomes
Primary Outcome Measures
Uptake of the developed mobile application (acceptability)
Uptake is defined as the act of downloading and installing the mobile application (Szinay, Jones, Chadborn, Brown, & Naughton, 2020). The uptake rate will measure the proportion of participants randomized to the EG group that downloaded the mobile application (via the Apple iOS App Store) versus those who did not do it.
Subjective engagement with the developed mobile application (acceptability)
Subjective engagement (self-reported) will be measured by using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF)(O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability; and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimensions will be compared to indicate which are rated more highly than other.
Objective engagement with the developed mobile application (acceptability)
Objective engagement (ie. number of screens viewed by participants) will be assessed. This data will be collected automatically when users log into the application.
Mobile application appreciation (acceptability)
The intervention appreciation will be measured with the User Version of the Mobile Application Rating Scale (uMARS) (Stoyanov, Hides, Kavanagh, & Wilson, 2016). The uMARS is a 20-item measure that includes 4 objective quality subscales regarding engagement, functionality, aesthetics, and information quality and 1 subjective quality subscale. Each item is rated on a 5-point scale ranging from inadequate (+1) to excellent (+5). The possible total score ranges between 20 and 100; a higher scores indicates a higher appreciation.
Secondary Outcome Measures
Online recruitment rate (feasibility of the study processes)
The recruitment rate (ie. number of participants who signed the inform consent form) will be assessed.
Adherence to data collection methods (feasibility of the study processes)
The adherence to data collection methods (ie. number of missing data) will be assessed.
Attrition rate (feasibility of the study processes)
The attrition rate will be measured by taking into account the proportion of participants who completed only the baseline but no follow-up assessment (study dropouts). The proportion of participants who completed the baseline assessment and only one follow-up and the proportion of study completers (who completed all assessments) will also be determined. Loss-to-follow up in both intervention groups will be compared (experimental VS control groups).
Full Information
NCT ID
NCT05099016
First Posted
August 31, 2021
Last Updated
August 24, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
1. Study Identification
Unique Protocol Identification Number
NCT05099016
Brief Title
Joint Effort Study
Acronym
JointEffort
Official Title
Taking Action to Better Manage Cannabis Use Among Young Adults: Preliminary Evaluation of a Digital Tailored Prevention Tool With a Pilot Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot randomized controlled trial (RCT) will be conducted to evaluate the acceptability and feasibility of a digital tailored prevention tool (i.e., the Joint Effort mobile application) aimed at supporting university-level students into taking action on their cannabis use. The two main objectives of the proposed study are:
To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.
To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Joint Effort (mobile application)
Arm Type
Experimental
Arm Description
The Joint Effort mobile application aims to support young adults into taking action on their cannabis use. Based on the Theory of Planned Behaviour, the content focuses on intention, attitude and perceived behavioral control. Various intervention methods and strategies are used to address these determinants (e.g., personalized feedback, persuasive communication, self-observation and activation of intention). The objectives includes: to allow the individual to become aware (or more aware) of their cannabis use, to support the individual's decision-making process of taking action on their cannabis use, to guide and support the establishment and sustainability of an action plan. An optional logbook-type feature (weekly journal of cannabis use) allows personalized monitoring and data collection throughout the course of the intervention.
Arm Title
Brief normative feedback and standard information
Arm Type
Active Comparator
Arm Description
The comparator is composed of a a brief normative feedback regarding last month frequency of cannabis use and basic reliable non personalized information on lower-risk cannabis use (official public websites).
Intervention Type
Other
Intervention Name(s)
Joint Effort
Intervention Description
The Joint Effort intervention is available in the form of an iPhone mobile application (running on iOS 13 and 14) in French language. It aims to support young adults in school who have used cannabis in the past month into taking action on their cannabis use.
Intervention Type
Other
Intervention Name(s)
Brief normative feedback and standard information
Intervention Description
The brief normative feedback is based on the frequency of cannabis use use. Participants will also be offered basic reliable non personalized information on lower-risk cannabis use in the form of official public websites.
Primary Outcome Measure Information:
Title
Uptake of the developed mobile application (acceptability)
Description
Uptake is defined as the act of downloading and installing the mobile application (Szinay, Jones, Chadborn, Brown, & Naughton, 2020). The uptake rate will measure the proportion of participants randomized to the EG group that downloaded the mobile application (via the Apple iOS App Store) versus those who did not do it.
Time Frame
6 months
Title
Subjective engagement with the developed mobile application (acceptability)
Description
Subjective engagement (self-reported) will be measured by using the validated French version (Fontaine et al., 2020) of the User Engagement Scale - Short Form (UES-SF)(O'Brien et al., 2018). This 12-item instrument serves to measure four dimensions of engagement: 1) aesthetic appeal; 2) focused attention; 3) perceived usability; and 4) reward factor. Possible answers range from strongly disagree (+1) to strongly agree (+5). The possible total score ranges between 12 and 60. The score for each item will be interpreted and the scores for each dimensions will be compared to indicate which are rated more highly than other.
Time Frame
4-weeks post baseline
Title
Objective engagement with the developed mobile application (acceptability)
Description
Objective engagement (ie. number of screens viewed by participants) will be assessed. This data will be collected automatically when users log into the application.
Time Frame
6 months
Title
Mobile application appreciation (acceptability)
Description
The intervention appreciation will be measured with the User Version of the Mobile Application Rating Scale (uMARS) (Stoyanov, Hides, Kavanagh, & Wilson, 2016). The uMARS is a 20-item measure that includes 4 objective quality subscales regarding engagement, functionality, aesthetics, and information quality and 1 subjective quality subscale. Each item is rated on a 5-point scale ranging from inadequate (+1) to excellent (+5). The possible total score ranges between 20 and 100; a higher scores indicates a higher appreciation.
Time Frame
2-weeks post baseline
Secondary Outcome Measure Information:
Title
Online recruitment rate (feasibility of the study processes)
Description
The recruitment rate (ie. number of participants who signed the inform consent form) will be assessed.
Time Frame
6 months
Title
Adherence to data collection methods (feasibility of the study processes)
Description
The adherence to data collection methods (ie. number of missing data) will be assessed.
Time Frame
baseline, 4-weeks post baseline, 8-weeks post baseline
Title
Attrition rate (feasibility of the study processes)
Description
The attrition rate will be measured by taking into account the proportion of participants who completed only the baseline but no follow-up assessment (study dropouts). The proportion of participants who completed the baseline assessment and only one follow-up and the proportion of study completers (who completed all assessments) will also be determined. Loss-to-follow up in both intervention groups will be compared (experimental VS control groups).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
active cannabis user (i.e., having used cannabis at least once in the past month)
able to understand French
own an iPhone (running on iOS 13 or higher).
Facility Information:
Facility Name
Université de Montréal
City
Montréal
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.crsi.umontreal.ca/en/
Description
Related Info
URL
https://etudejointeffort.ca/home
Description
Related Info
Learn more about this trial
Joint Effort Study
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