Social IsolationVGVNCT05046288
Virtual Guided Tour of the MMFA for Prevention of Social Isolation
A study testing Virtual guided tours in people with Social Isolation and Well Aging, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Isolation, Well Aging, Quality of Life
- What is being tested?
- Virtual guided tours
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2022to 1 Jun 2022
- 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
- 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.
Who cannot join
- 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.
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 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.
- Conditions
- Social Isolation, Well Aging, Quality of Life, Healthy Aging
- Being tested
- Virtual guided tours
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual guided toursOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will participate to the 3-month cycle of virtual guided tour of the MMFA and will complete assessments at M0 and at M3 Receives: Other: Virtual guided tours |
| Group 2 | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social isolation
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.
Measured: 3 months
Secondary outcomes (5)
Frailty
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
Measured: 3 months
socio-geriatric vulnerability
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.
Measured: 3 months
Well-being
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).
Measured: 3 months
quality of life
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:
- a questionnaire of five questions with score per question ranged from 1 (i.e., no issue) to 5 (i.e., worse issue),
- and a visual analogic scale of how good or bad participant health was. This scale is numbered from 0 (i.e., worse health participant can imagine) to 100 (i.e., best health participant can imagine).
Measured: 3 months
compliance
compliance to the MMFA visits will be assessed by counting the number of virtual tours completed during the 3-month period of intervention
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social IsolationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Olivier Beauchet, Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046288
- Sponsor's protocol ID
- 2022-1338
- Acronym
- VGV
- Status last verified
- Feb 2023
- First submitted
- 8 Sep 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beauchet O, Matskiv J, Galery K, Goossens L, Lafontaine C, Sawchuk K. Benefits of a 3-month cycle of weekly virtual museum tours in community dwelling older adults: Results of a randomized controlled trial. Front Med (Lausanne). 2022 Aug 16;9:969122. doi: 10.3389/fmed.2022.969122. eCollection 2022.
PubMed 36052331
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. 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 Guided Tours Oto Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members Experiencing Social Isolation
- ClinicalTrials.gov ID
- NCT05046288
- Acronym / sponsor ID
- VGV / 2022-1338
- Conditions
- Social Isolation, Well Aging, Quality of Life, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-MontréalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 16 Sep 2021 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Virtual guided toursParticipants will participate to the 3-month cycle of virtual guided tour of the MMFA and will complete assessments at M0 and at M3 |
| Group 2 | No intervention | –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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Virtual guided toursThe 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. | Other | Group 1 |
Primary outcome
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.
5 secondary outcomes
Frailty
Time frame: 3 months
socio-geriatric vulnerability
Time frame: 3 months
Well-being
Time frame: 3 months
quality of life
Time frame: 3 months
compliance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 36052331Beauchet O, Matskiv J, Galery K, Goossens L, Lafontaine C, Sawchuk K. Benefits of a 3-month cycle of weekly virtual museum tours in community dwelling older adults: Results of a randomized controlled trial. Front Med (Lausanne). 2022 Aug 16;9:969122. doi: 10.3389/fmed.2022.969122. eCollection 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual guided tours in people with Social Isolation and Well Aging, run by Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT05046288, which also lists 1 linked publication.
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 8 Feb 2023.