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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05099016
Other study ID # 21.196
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date July 31, 2022

Study information

Verified date August 2021
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date July 31, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Joint Effort
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.
Brief normative feedback and standard information
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.

Locations

Country Name City State
Canada Université de Montréal Montréal

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Primary 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. 4-weeks post baseline
Primary 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. 6 months
Primary 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. 2-weeks post baseline
Secondary Online recruitment rate (feasibility of the study processes) The recruitment rate (ie. number of participants who signed the inform consent form) will be assessed. 6 months
Secondary Adherence to data collection methods (feasibility of the study processes) The adherence to data collection methods (ie. number of missing data) will be assessed. baseline, 4-weeks post baseline, 8-weeks post baseline
Secondary 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). 6 months
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