NCT04593433

Brief Summary

Social isolation is defined as the objective and/or subjective reduction of number and quality of interpersonal contacts leading to a loss of an individual's social role and stigmatization. It is a major problem in Canadian society with a high prevalence in the older population (30% in individuals aged 65 and over, representing 1.5 million individuals). Social isolation is associated with a wide range of mental and physical health problems that leads to an increase in the use of health and social services. This issue increased with the coronavirus disease (COVID-19) pandemic which attacking your society at its core. Social distancing and in particular home confinement exacerbated social isolation of frailer groups like the elderly people. In 2016, the International Federation on Ageing reported that "the main new problem facing seniors in Canada is maintaining their social contacts and activities". This highlights the need for efficient and effective interventions to improve the social inclusion of older adults experiencing social isolation. Research suggests that art-based activities carried out at museums have significant benefits for older adults experiencing social isolation, and may foster social inclusion, well-being, quality of life and mitigate frailty. Yet few studies have examined empirically the effects of museum art-based activities in older adults experiencing social isolation. In 2019, the principal investigator of this research conducted an experimental pilot study based on a pre-post intervention (i.e., 3-month cycle of weekly guided tours carried out at the Montreal Museum of Fine Arts (MMFA)), single arm, prospective and longitudinal follow-up named "Effects of Montreal Museum of Fine Arts visits and older community dwellers with a precarious state: An experimental study", which indicated the potential of museum tours to improve social inclusion, well-being, the quality of life and frailty in older community members experiencing social isolation. However, these studies were performed before the COVID-19 crisis and were in-site activities. The principal investigator hypothesizes that a 3-month cycle of virtual weekly MMFA tours may induce changes in well-being, quality of life and health condition in older community dwellers participating like the 'Beautiful Thursday' cycle, and that this activity can prevent the worsening of vulnerability and social isolation due to social distancing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

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

October 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2021

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

October 13, 2020

Last Update Submit

August 23, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Well-being

    using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) self-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). Scores can range from a minimum of 14 to a maximum of 70 points. Higher scores are associated with higher levels of mental well-being

    3 months

  • Quality of life

    using EuroQol-5D (EQ-5D), 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 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), each question ranged from 0 (i.e., no issue) to 25 (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).

    3 months

  • frailty

    using CESAM questionnaire, composed of 20 items providing 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 between 8 and 12, and important frailty with a score above 12).

    3 months

  • social isolation

    using the digital form of the 11-item Dike Social Support Index (DSSI). The index is composed of 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 the mean score of 11-item DSSI and its distribution in three categories.

    3 months

  • socio-geriatric vulnerability

    using ESOGER questionnaire, composed of 17 items exploring the COVID risk, the COVID past history, 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). The ESOGER categorizes state of vulnerability in three levels (Low, Moderate and High vulnerability).

    3 months

Secondary Outcomes (2)

  • Incident planned and unplanned visits to physicians, Emergency Department (ED) and hospitalization

    3 months

  • compliance

    3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Group with the virtual museum guided tours

Other: Museum virtual guided tours

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 5 participants. They meet online one time per week for a 20 to 25 min of a visit tour during a 3-month period. Each tour is different and supervised by a MMFA trained guide.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Being 65 years and over
  • Having an Internet access and an electronic device (smartphone and/or 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, and the guided tours will be virtual.
  • Understanding and writing the language of the recruitment centre (i.e., French or English)

You may not qualify if:

  • a concomitant participation to an experimental study,
  • planning to have a journey over one week during the cycle of visits,
  • having participated to a participatory art-based activity of the MMFA during the 6 month-period before the recruitment,
  • not speaking the language of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Social IsolationFrailty

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Beauchet, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2020

First Posted

October 20, 2020

Study Start

March 4, 2021

Primary Completion

July 4, 2021

Study Completion

July 4, 2021

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations