NCT04298047

Brief Summary

Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

March 4, 2020

Last Update Submit

February 22, 2024

Conditions

Keywords

Community-dwellersolder adultsmuseumart

Outcome Measures

Primary Outcomes (1)

  • Social isolation

    The 11-item Duke Social Support Index (DSSI) 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 (7)

  • Frailty

    3 months

  • Well-being

    3 months

  • Quality of life using the EuroQol-5D (EQ-5D)

    3 months

  • Participants' socio-demographic characteristics

    3 months

  • Interpersonal interactions

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

The participants in the Intervention group will be participants of the MMFA participatory art-based activity.

Other: participatory art-based activity

Control Group

NO INTERVENTION

The Control arm will be composed of older community dwellers matched on age and sex compared to the Intervention group but who will not be participants at the MMFA participatory art-based activity.

Interventions

The intervention is a 3-month cycle of weekly guided tours carried out at the MMFA. Each visit will be performed with a group of 8 participants and a trained guide. They will meet at the museum once per week for a 45 min museum guided tour during a 3-month period. Each visit will be different and supervised by a museum guide. Regardless the topic of the visits, each visit will be standardized and separated in two consecutive phases: (1) Presentation of the objectives of the activity and (2) tour with a guide. Guided tours will target visual art (i.e., painting). They will be tailor-made and based on emotions and interactions in front of painting. The levels of information given to participants will regularly (i.e., each month) increase during the 3-month cycle of museum guided tours. The participants will be separated in 8 groups of 8 individuals per week. The same guide will manage each group of 8 participants during the 12 planned visits.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Being 65 years and over
  • Having an Internet access with an electronic device (i.e.; laptop, computer, smartphone, 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
  • Understanding and writing the language of the recruitment centre (i.e., French or English)
  • Life expectancy estimated over 3 months as the duration of the follow-up is 3 months

You may not qualify if:

  • Concomitant participation to another clinical trial,
  • Having participated to a participatory art-based activity of the MMFA,
  • 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

Study Officials

  • Olivier Beauchet, MD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The design is a unicentre (Jewish General Hospital; Montreal, Quebec, Canada), clinical, randomized, controlled, single blinded (i.e.; investigators), superiority trial, with two parallel arms (Intervention and Control groups), comparative (comparison between Intervention and Control groups) and analyzed with the intention-to-treat.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor of Geriatrics, Holder of the Dr. Joseph Kaufmann Chair in Geriatric Medicine Clinician Scientist, Department of Medicine, Division of Geriatric Medicine Director of Centre of Excellence on Longevity, RUISSS McGill, McGill University

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 1, 2025

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations