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A 3-month Cycle of Virtual Guided Tours to Promote Health in Older Community Members in a Context of COVID-19 Induced Social Isolation: a Pilot Study (VGV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04593433
Recruitment Status : Completed
First Posted : October 20, 2020
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Olivier Beauchet, Jewish General Hospital

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE October 20, 2020
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE March 4, 2021
Actual Primary Completion Date July 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Well-being [ Time Frame: 3 months ]
    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
  • Quality of life [ Time Frame: 3 months ]
    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).
  • frailty [ Time Frame: 3 months ]
    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).
  • social isolation [ Time Frame: 3 months ]
    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.
  • socio-geriatric vulnerability [ Time Frame: 3 months ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Well-being [ Time Frame: 3 months ]
    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).
  • Quality of life [ Time Frame: 3 months ]
    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).
  • frailty [ Time Frame: 3 months ]
    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).
  • social isolation [ Time Frame: 3 months ]
    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.
  • socio-geriatric vulnerability [ Time Frame: 3 months ]
    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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2020)
  • Incident planned and unplanned visits to physicians, Emergency Department (ED) and hospitalization [ Time Frame: 3 months ]
    recorded at the end of the cycle by asking directly to the participants
  • compliance [ Time Frame: 3 months ]
    determined by the total number of guided tours performed, on a maximum of 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 3-month Cycle of Virtual Guided Tours to Promote Health in Older Community Members in a Context of COVID-19 Induced Social Isolation: a Pilot Study
Official Title  ICMJE A 3-month Cycle of Virtual Weekly Montreal Museum of Fine Arts Tours to Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members : a Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Social Isolation
  • Quality of Life
  • Well Aging
  • Frailty
Intervention  ICMJE Other: Museum virtual guided tours
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.
Study Arms  ICMJE Experimental: Intervention
Group with the virtual museum guided tours
Intervention: Other: Museum virtual guided tours
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2021)
44
Original Estimated Enrollment  ICMJE
 (submitted: October 13, 2020)
40
Actual Study Completion Date  ICMJE July 4, 2021
Actual Primary Completion Date July 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04593433
Other Study ID Numbers  ICMJE 2021-2604
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Olivier Beauchet, Jewish General Hospital
Original Responsible Party Olivier Beauchet, Jewish General Hospital, MD, PhD
Current Study Sponsor  ICMJE Jewish General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier Beauchet, MD Jewish General Hospital
PRS Account Jewish General Hospital
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP