NCT06609642

Brief Summary

The study aims at examining the impact of an immersive and interactive digital application (App) that uses impressionist artworks to promote the mental well-being of both young and older adults. The goal is to study the usability and accessibility of this App, particularly for older adults, who may have sensory impairments and lower digital literacy compared to younger adults. The study is based on the hypothesis that the App, which allows interaction with paintings by Claude Monet and Helen McNicoll, can trigger positive emotions, thereby improving users' well-being. The App uses artificial intelligence to create extensions of the paintings and music based on the sonification of electrophysiological signals captured from plants. The study seeks to answer four research questions:

  1. 1.The usage behaviors of young and older adults with the App.
  2. 2.The impressions and feedback from users after testing the App.
  3. 3.The obstacles and enablers to the App's use.
  4. 4.The expectations and needs of users for better use of the App.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

1 year

First QC Date

September 18, 2024

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Observation grid for behaviors and difficulties encountered

    Observation guide. Observation by a member of the research team will examine how participants use the App, in order to document usage behaviors and difficulties encountered.

    Day 1, during the use of the app, duration : 30 minutes

  • Impressions and feedback

    Semi-structured interview. The characteristics of these interviews are as follows: Format: The interviews are conducted with the participant and one or two members of the principal researcher's team. Interview guide: A structured guide is used to organize, standardize, and systematize the collection of information. This guide covers the following topics: impressions of the App (design, aesthetics, usability); participant's digital skills and abilities (integration and understanding of the tool); ease of interaction, enablers and barriers; impressions of AI in general; expectations, needs, and interests in such an App. Recording: With the participants' consent, the interviews are audio-recorded. The recording will be done using Audacity software, with the aim of producing a verbatim transcript for data analysis. Duration: 30 minutes.

    Day 1, right after the use of the app, duration : 30 minutes

  • Enablers and barriers

    Semi-structured interview. The characteristics of these interviews are as follows: Format: The interviews are conducted with the participant and one or two members of the principal researcher's team. Interview guide: A structured guide is used to organize, standardize, and systematize the collection of information. This guide covers the following topics: impressions of the App (design, aesthetics, usability); participant's digital skills and abilities (integration and understanding of the tool); ease of interaction, enablers and barriers; impressions of AI in general; expectations, needs, and interests in such an App. Recording: With the participants' consent, the interviews are audio-recorded. The recording will be done using Audacity software, with the aim of producing a verbatim transcript for data analysis. Duration: 30 minutes.

    Day 1, right after the use of the app, duration : 30 minutes

  • Expectations and needs

    Semi-structured interview. The characteristics of these interviews are as follows: Format: The interviews are conducted with the participant and one or two members of the principal researcher's team. Interview guide: A structured guide is used to organize, standardize, and systematize the collection of information. This guide covers the following topics: impressions of the App (design, aesthetics, usability); participant's digital skills and abilities (integration and understanding of the tool); ease of interaction, enablers and barriers; impressions of AI in general; expectations, needs, and interests in such an App. Recording: With the participants' consent, the interviews are audio-recorded. The recording will be done using Audacity software, with the aim of producing a verbatim transcript for data analysis. Duration: 30 minutes.

    Day 1, right after the use of the app, duration : 30 minutes

Secondary Outcomes (5)

  • Sociodemographics

    Day 1

  • level of visual art knowledge

    Day 1

  • level of music knowledge

    Day 1

  • Ecoanxiety level - Climate change

    Day 1

  • Ecoanxiety level - Environmental issues

    Day 1

Study Arms (2)

Young adults

EXPERIMENTAL

Male and female, aged 18 to 35 years

Behavioral: Art application

Old adults

EXPERIMENTAL

Male and female, aged 60 years and more

Behavioral: Art application

Interventions

Art applicationBEHAVIORAL

First, participants will complete questionnaires that will provide us with their socio-demographic information, their level of knowledge in visual arts and music, as well as their level of eco-anxiety. Second, participants will use the application on a touchscreen tablet: 1. A member of the research team will give a brief explanation of the application. 2. The participant will use the application on the touchscreen tablet. 3. A member of the research team will be present in the room during the test as an observer. Third, the participant will answer questions from a member of the research team: impressions of the tool, digital skills and abilities, enablers and barriers to the use of the tool, expectations, needs, and interests in the application.

Old adultsYoung adults

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsConcordance of sex and gender
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Concordance of sex and gender.
  • No psychiatric or cognitive disorders.
  • Ability to understand spoken and written French.
  • Provide written consent to participate in the study.

You may not qualify if:

  • Non-binary.
  • Inability to provide informed consent to participate in the study.
  • Participation in a concurrent experimental clinical study to avoid interference with our study.
  • Inability to understand spoken and written French.
  • Having moderate to severe visual or auditory impairment.
  • Young adults:
  • Older adults:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W1W5, Canada

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 18, 2024

First Posted

September 24, 2024

Study Start

January 22, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations