- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05445453
Museum Prescription by a Physician for a Visit to the MBAM (PM)
Museum Prescription by a Physician for a Visit to the Montreal Museum of Fine Arts: Assessment of Effects.
In recent years, museums have participated in the patient care journey by using art to enhance their quality of life and well-being. Since 2015, the Montreal Museum of Fine Arts (MMFA) and Dr. Beauchet have developed an Action-Research program exploring the effects of participatory art activities for community elders conducted at the MMFA, known as the Arts & Longevity Lab (ALL). The mandate of ALL is to improve the well-being, quality of life and health (i.e. mental and physical state) of individuals and patients through the practice of visual arts activities (i.e. arts that produce objects perceived by the eyes).
Since 2019, the MMFA has developed in collaboration with Médecins Francophones du Canada museum visits prescribed by a primary care physician as a new intervention. Today, it is necessary to improve the knowledge on the effects of this museum visit prescription
The overall objective of this study is to examine the effects of a visit to the MMFA prescribed by a primary care physician on the mental health (well-being and quality of life) of patients living in Montreal.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3W 1W5
- CRIUGM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age 18 and over
- having Internet access at home with an electronic device (computer, keyboard, or smartphone)
- having no dementia
- speaking English or French
- committing to visiting the museum within 3 months of the prescription.
Exclusion Criteria:
- individuals participating in a clinical trial at the same time, to avoid interference with the results of the intervention being studied in this protocol
- individuals with dementia. There are no tests for dementia. The physicians involved in the pre-recruitment process are aware of the cognitive status of their patients. Therefore, they will be able to avoid offering the study to a patient with dementia if such a diagnosis appears in the medical file.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Physicians participating in the research project will be able to prescribe a visit to the Museum to any of their patients for whom they deem this museum prescription necessary. Only patients who meet the inclusion criteria will be offered to participate in the research. If patients refuse or do not meet the inclusion criteria, they may be prescribed a museum visit but will not be offered the study. After obtaining informed consent, the patient will be asked to complete 2 sets of self-administered questionnaires: in the 2 days prior to the visit and in the 2 days following the MBAM visit. |
The intervention is a visit of the MMFA. This visit can be done alone or accompanied. The visit of the MMFA is free for the patient. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life
Time Frame: 3 months
|
Quality of life will be assessed using the EuroQol-5D (EQ-5D). EuroQol-5D is composed of two parts:
This questionnaire will be completed online on the CRIUGM web platform using an electronic device. |
3 months
|
Well-being
Time Frame: 3 months
|
Well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). The WEMWBS is a validated questionnaire composed by a 14-item positively worded scale and five response categories. It covers most aspects of positive mental health (positive thoughts and feelings). This questionnaire will be completed online on the CRIUGM web platform using an electronic device. |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Health Status
Time Frame: 3 months
|
Physical health status will be assessed using the CRIUGM Self-AdMinistered questionnaire (CESAM). The CESAM has been previously developed and validated. It is composed of 20 items exploring several domains:
The CESAM provides two complementary scores:
This questionnaire will be completed online on the CRIUGM web platform using an electronic device. |
3 months
|
Social Isolation
Time Frame: 3 months
|
Social isolation will be assessed using the 11-item Duke Social Support Index (DSSI). This index includes two subscales:
The DSSI score ranges from 11 to 33, with higher scores indicating higher levels of social inclusion. Scores for the 11 items are combined and categorized as low (score ≤26), high (score 27-29), and very high (score 30-33). We will use the mean score of the 11-item DSSI and its breakdown into three categories as the primary outcome. This questionnaire will be completed online on the CRIUGM web platform using an electronic device. |
3 months
|
Prescribing context
Time Frame: 3 months
|
Researchers will also study the prescribing context.
A document will be filled by primary care physicians to give additional informations on the prescribing context such as the date of the prescription and the reason of the prescription.
|
3 months
|
Satisfaction from the visit to the museum
Time Frame: 3 months
|
A short questionnaire will be given to participants to the intervention at the end of the visit to the museum.
This questionnaire will give additionnal information on the satisfaction from the visit and whether the visit was made alone or accompanied.
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MP-53-2023-2627
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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