NCT05046288

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

September 8, 2021

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (5)

  • Frailty

    3 months

  • socio-geriatric vulnerability

    3 months

  • Well-being

    3 months

  • quality of life

    3 months

  • compliance

    3 months

Study Arms (2)

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

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

Interventions

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.

Group 1

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65 and over;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W5, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Senior researcher, Director of laboratory

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 16, 2021

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations