Joint Effort Study

Not Applicable

Completed

• Conditions: Cannabis Use

• Registration Number: NCT05099016
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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:

1. To assess the acceptability of the Joint Effort mobile application in terms of uptake, engagement and intervention appreciation.

2. To document the feasibility of the study processes in terms of online recruitment rate, adherence to online data collection methods, and attrition rate.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-10-18
• Study First Posted: 2021-10-29
• Study Start: 2021-11-15
• Primary Completion: 2022-04-30
• Study Completion: 2022-07-31
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjective engagement with the developed mobile application (acceptability)	4-weeks post baseline	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)	6 months	Objective engagement (ie. number of screens viewed by participants) will be assessed. This data will be collected automatically when users log into the application.
Uptake of the developed mobile application (acceptability)	6 months	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.
Mobile application appreciation (acceptability)	2-weeks post baseline	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

Name	Time	Method
Adherence to data collection methods (feasibility of the study processes)	baseline, 4-weeks post baseline, 8-weeks post baseline	The adherence to data collection methods (ie. number of missing data) will be assessed.
Online recruitment rate (feasibility of the study processes)	6 months	The recruitment rate (ie. number of participants who signed the inform consent form) will be assessed.
Attrition rate (feasibility of the study processes)	6 months	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).

Trial Locations

Locations (1)

Université de Montréal; 🇨🇦 Montréal, Canada