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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05445453
Other study ID # MP-53-2023-2627
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2022
Est. completion date December 22, 2023

Study information

Verified date February 2024
Source Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 22, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Museum 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.

Locations

Country Name City State
Canada CRIUGM Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life Quality of life will be assessed using the EuroQol-5D (EQ-5D).
EuroQol-5D is composed of two parts:
a five-question questionnaire with a score per question ranging from 1 (no problem) to 5 (severe problem), so that the sum ranged from 0 (no problem) to 25 (severe problem).
a visual analogue scale on participants' perceived health. This scale is numbered from 0 (i.e., the worst health the participant can imagine) to 100 (i.e., the best health the participant can imagine).
This questionnaire will be completed online on the CRIUGM web platform using an electronic device.
3 months
Primary Well-being 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 Physical Health Status 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:
weight loss and its extent;
polypharmacy defined by a number of therapeutic classes taken on a daily basis = 5;
vision, hearing, and memory problems;
use of home support;
6-item activities of daily living scale, 4-item instrumental activities of daily living scale;
mood assessed
regular physical activity defined as at least 1 hour per week in the past month;
and history of falls in the past 12 months.
The CESAM provides two complementary scores:
An overall frailty score ranging from 0 to 18
A four-stage categorization of frailty
This questionnaire will be completed online on the CRIUGM web platform using an electronic device.
3 months
Secondary Social Isolation Social isolation will be assessed using the 11-item Duke Social Support Index (DSSI).
This index includes two subscales:
social interaction (i.e., frequency of interactions)
subjective support (i.e., satisfaction with emotional support provided).
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
Secondary Prescribing context 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
Secondary Satisfaction from the visit to the museum 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
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