Social InteractionNCT04298047
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Tours
A study testing participatory art-based activity in people with Social Interaction and Quality of Life, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Interaction, Quality of Life, Health
- What is being tested?
- participatory art-based activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Concomitant participation to another clinical trial,
- Having participated to a participatory art-based activity of the MMFA,
- Not speaking the language of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Social Interaction, Quality of Life, Health
- Being tested
- participatory art-based activity
- Keywords
- Community-dwellers, older adults, museum, art
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participatory art-based activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The participants in the Intervention group will be participants of the MMFA participatory art-based activity. Receives: Other: participatory art-based activity |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Social isolation
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.
Measured: 3 months
Secondary outcomes (7)
Frailty
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.
Measured: 3 months
Well-being
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)
Measured: 3 months
Quality of life using the EuroQol-5D (EQ-5D)
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.
Measured: 3 months
Participants' socio-demographic characteristics
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
Measured: 3 months
Interpersonal interactions
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.
Measured: 3 months
Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
assessed counting the number of workshops completed during the 3-months period of intervention.
Measured: 3 month
Satisfaction concerning the project assessed by self-questionnaire
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison between Intervention and Control groups) and analyzed with the intention-to-treat.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Beauchet, Jewish General Hospital
- Investigators
- Olivier Beauchet, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298047
- Sponsor's protocol ID
- 20201789
- Status last verified
- Feb 2024
- First submitted
- 4 Mar 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04298047
- Acronym / sponsor ID
- 20201789
- Conditions
- Social Interaction, Quality of Life, Health
- Keywords
- Community-dwellers, older adults, museum, art
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison between Intervention and Control groups) and analyzed with the intention-to-treat.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: participatory art-based activityThe participants in the Intervention group will be participants of the MMFA participatory art-based activity. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Concomitant participation to another clinical trial,
- Having participated to a participatory art-based activity of the MMFA,
- Not speaking the language of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| participatory art-based activityThe 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. | Other | Intervention group |
Primary outcome
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.
7 secondary outcomes
Frailty
Time frame: 3 months
Well-being
Time frame: 3 months
Quality of life using the EuroQol-5D (EQ-5D)
Time frame: 3 months
Participants' socio-demographic characteristics
Time frame: 3 months
Interpersonal interactions
Time frame: 3 months
Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
Time frame: 3 month
Satisfaction concerning the project assessed by self-questionnaire
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Beauchet, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing participatory art-based activity in people with Social Interaction and Quality of Life, run by Jewish General Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social isolation (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.