- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05046288
Virtual Guided Tour of the MMFA for Prevention of Social Isolation (VGV)
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Guided Tours Oto Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members Experiencing Social Isolation
It has previously been reported that participatory art-based activities may improve social inclusion, well-being, quality of life and health condition. Findings from the investigator's first study seem to confirm that the MMFA participatory art-based activity may improve well-being, quality of life and health condition in older community dwellers. However, these studies were performed before the COVID-19 crisis and were guided tours performed at the MMFA. A pilot study on virtual guided tour has been performed during COVID-19 pandemic (spring 2021). There is a need to confirm benefits with a randomized clinical trial.
The hypothesize for this study is that a 3-month cycle of virtual weekly MMFA tours may induce changes in social isolation, well-being, quality of life and health condition (i.e., reduction of frailty) in older community dwellers. Because there is a positive correlation between severity of frailty and the occurrence of undesirable events like Emergency department (ED) visits and hospitalizations, the investigator hypothesizes that virtual guided tours may decrease the frequency of ED visits and hospitalizations.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H3W 1W5
- CRIUGM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 65 and over;
- having a low level of social inclusion defined with the 11-item Duke Social Support Index (DSSI) score ≤ 26/3323;
- living in Quebec, at home in an urban area;
- reading, understanding and writing the languages of the recruitment centre (i.e., French or English or Chinese mandarin) because all the questionnaires are available in French, in English and in Chinese mandarin, and because the guides of the museum performing the virtual guided tours speak French and/or English, with a translator in Chinese mandarin.
- Having an Internet access and an electronic device (smartphone, laptop, computer and/or tablet with a functional cam) at the participant's place of living as the repetitive assessments for this study will be performed on the web platform of the CRIUGM, and the guided tours will be virtual.
Exclusion Criteria:
- Cannot participate to a clinical trial at the same time, to avoid interferences with the outcomes of the studied intervention in this protocol.
- Having participated to a participatory art-based activity of the MMFA during the 3 month-period before the recruitment. A participation to any other museum activities may be assimilate to an intervention. As it could interfere with our outcomes, participants are not allowed to participate to any other museum activity, in any museum, during their 3-month participation. We previously showed that museum activities may change the outcomes studied in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
Participants will participate to the 3-month cycle of virtual guided tour of the MMFA and will complete assessments at M0 and at M3
|
The intervention is a participatory art-based activity which consists in MMFA virtual guided tours.
Each virtual guided tour is performed with a group of 6 to 7 participants.
They meet online one time per week for a 30 to 45 min of a guided tour during a 3-month period.
Each tour is different and supervised by a MMFA trained guide.
|
NO_INTERVENTION: Group 2
Participants will not participate to the 3-month cycle of virtual guided tour of the MMFA but will complete assessments at M0 and at M3
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social isolation
Time Frame: 3 months
|
social isolation which will be assessed using the 11-item Duke Social Support Index (DSSI).
.The index 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 frailty which will be assessed using the CRIUGM Self-AdMinistered questionnaire (CESAM). The CESAM is composed of a maximum of 28 items exploring age, sex, nutrition, place of life, social resources, number of drugs taken on a daily basis, memory complaint, mood and general feeling, fatigue, activities of daily living scale, instrumental activities of daily living scale, physical activity and history of previous falls. Items correspond to a question in closed-ended format (i.e., yes or no, or calling for a specific answer). The CESAM provides two complementary information: 1) A global score of frailty ranged from 0 (i.e., best health and functional condition) to 18 (i.e., worse health and functional condition) and 2) Categorized health condition in four levels (vigorous with a score between 0 and 3, mild frailty with a score between 4 and 7, moderate frailty with a score bet |
3 months
|
socio-geriatric vulnerability
Time Frame: 3 months
|
socio-geriatric vulnerability will be assessed using the digital form of a self-administered questionnaire ESOGER.
The ESOGER is composed of a maximum of 15 questions exploring the COVID risk, the COVID past history, COVID vaccination the social isolation risk due to COVID (access to food, home support and healthcare, contact with external persons, anxiety).
Items correspond to a question in closed-ended format (i.e., yes or no, or calling for a specific answer).
Incident planned and unplanned visits to physicians, Emergency Department (ED) and hospitalization during the 3-month cycle of virtual weekly MMFA tours will be only recorded at the end of the cycle.
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3 months
|
Well-being
Time Frame: 3 months
|
Well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) self-questionnaire.
WEMWBS is a validated questionnaire composed by 14 positively worded item scale with five response categories.
It covers most aspects of positive mental health (positive thoughts and feelings).
|
3 months
|
quality of life
Time Frame: 3 months
|
quality of life will be assessed using the EuroQol-5D (EQ-5D). This test is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. It provides a simple descriptive profile and a single index value for health status. EQ-5D is composed of two parts:
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3 months
|
compliance
Time Frame: 3 months
|
compliance to the MMFA visits will be assessed by counting the number of virtual tours completed during the 3-month period of intervention
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3 months
|
Collaborators and Investigators
Publications and helpful links
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-1338
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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