- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298047
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Tours
February 22, 2024 updated by: Olivier Beauchet, Jewish General Hospital
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Tours to Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members Experiencing Social Isolation
Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Social isolation is a major problem for the Canadian society because of its: (1) high prevalence in the older population (30% in individuals aged 65 and over, which represents 1.5 million individuals), (2) association with a wide range of mental and physical health problems and (3) increased use of health and social services.
Museum art-based activities have demonstrated benefits on an individual's sense of social inclusion, their well-being, their quality of life and physical frailty.
Few studies have examined the effects of the participation in museum art-based activities in older community members experiencing social isolation.
In 2019, the team conducted an experimental pilot study comprised of pre-post intervention, single arm, prospective and a longitudinal follow-up.
This experiment indicated that a 3-month cycle of weekly visits to the Montreal Museum of Fine Arts (MMFA) in the form of a guided tour may improve the social inclusion of socially isolated older adults.
We hypothesize that it is possible to reproduce these previous positive results using a mixed methods approach that combines: (1) a qualitative phase comprised of observation of the guided tours; semi-structured interviews, focus groups and an analysis of relevant organizational documents; (2) a quantitative phase based on a randomized clinical trial (RCT).
Over a two-year period, we will examine whether and how a 3-month cycle of weekly MMFA tours may (1) improve social inclusion, well-being and quality of life, and (2) reduce frailty in older community members, living in Montreal, who are experiencing social isolation.
The study includes the participation of community workers who work with socially isolated older Montrealers, members of this community, as well as museum works and administrators.
Our research will not only include information on how the museum experience has affected older adults.
It will incorporate feedback from all of these participants leading to an evaluation of the program offered by the museum to better serve the future needs and desires of this population.
It will also benefit the participating organizations.
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H3T 1E2
- Jewish General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being 65 years and over
- Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, tablet) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the Centre of Excellence on Longevity of McGill University
- Understanding and writing the language of the recruitment centre (i.e., French or English)
- Life expectancy estimated over 3 months as the duration of the follow-up is 3 months
Exclusion Criteria:
- Concomitant participation to another clinical trial,
- Having participated to a participatory art-based activity of the MMFA,
- Not speaking the language of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The participants in the Intervention group will be participants of the MMFA participatory art-based activity.
|
The intervention is a 3-month cycle of weekly guided tours carried out at the MMFA.
Each visit will be performed with a group of 8 participants and a trained guide.
They will meet at the museum once per week for a 45 min museum guided tour during a 3-month period.
Each visit will be different and supervised by a museum guide.
Regardless the topic of the visits, each visit will be standardized and separated in two consecutive phases: (1) Presentation of the objectives of the activity and (2) tour with a guide.
Guided tours will target visual art (i.e., painting).
They will be tailor-made and based on emotions and interactions in front of painting.
The levels of information given to participants will regularly (i.e., each month) increase during the 3-month cycle of museum guided tours.
The participants will be separated in 8 groups of 8 individuals per week.
The same guide will manage each group of 8 participants during the 12 planned visits.
|
|
No Intervention: Control Group
The Control arm will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participants at the MMFA participatory art-based activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social isolation
Time Frame: 3 months
|
The 11-item Duke Social Support Index (DSSI) comprises two subscales: social interaction (i.e., frequency of interactions) and subjective support (i.e., satisfaction with emotional support provided).
DSSI score ranges from 11 to 33, increased score indicating higher levels of social insertion.
The scores of the 11 items are combined and categorized as low-fair (score ≤26), high (score 27-29) and very high (score 30-33).
We will use as primary outcome the mean score of 11-item DSSI and its distribution in three categories.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frailty
Time Frame: 3 months
|
The Centre of Excellence on longevity Self-AdMinistered questionnaire (CESAM).
This questionnaire is composed of 20 items examining different domains including weight loss; polypharmacy; vision, hearing and memory issues; use of home support (i.e., family, friend and/or professional); the activity of daily living and the instrumental activity daily living scales; mood; practice of regular physical activity and history of falls in the past 12 months.
|
3 months
|
|
Well-being
Time Frame: 3 months
|
Assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) questionnaire.
The WEMWBS covers most aspects of positive mental health (positive thoughts and feelings).
Its score ranges from 14 (i.e., none of the time) to 70 (i.e., all the time)
|
3 months
|
|
Quality of life using the EuroQol-5D (EQ-5D)
Time Frame: 3 months
|
EuroQol-5D self-questionnaire, evaluating mobility, usual activities, self-care, pain, anxiety and mood, from No problem to Unable, scored from 5 to 25, High score meaning a bad quality of life.
|
3 months
|
|
Participants' socio-demographic characteristics
Time Frame: 3 months
|
i.e., age, sex, marital status defined as married, living common-law, single, separated, divorced or widowed, place of living defined as home versus residence) and low household income using Canadian low-income cut-off
|
3 months
|
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Interpersonal interactions
Time Frame: 3 months
|
evaluation adapted from Observed Emotions Rating Scale (OERS).
The OERS is about the completion of observations of 5 categories listed in order to give an overall look at the participants' interpersonal interactions based on expression of emotions.
The 5 categories are; 1/ pleasure, 2/ anger, 3/ anxiety/fear, 4/ sadness, 5/ general alertness.
|
3 months
|
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Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
Time Frame: 3 month
|
assessed counting the number of workshops completed during the 3-months period of intervention.
|
3 month
|
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Satisfaction concerning the project assessed by self-questionnaire
Time Frame: 1 day
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self-questionnaire, qualitative (from 1 to 10: Dissatisfying to Satisfying), NO GLOBAL SCORE, each question is evaluated separately.
A mean of all questions to have a global note (/10) will eventually be done for each participant.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Olivier Beauchet, MD, McGill University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Actual)
December 31, 2023
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
March 4, 2020
First Submitted That Met QC Criteria
March 4, 2020
First Posted (Actual)
March 6, 2020
Study Record Updates
Last Update Posted (Estimated)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20201789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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