Quality of Life Clinical Trial
— VGVOfficial 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
NCT number | NCT05046288 |
Other study ID # | 2022-1338 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2022 |
Est. completion date | June 1, 2022 |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | June 1, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CRIUGM | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
3 months | |
Secondary | 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. | 3 months | |
Secondary | 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). | 3 months | |
Secondary | 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). |
3 months | |
Secondary | compliance | compliance to the MMFA visits will be assessed by counting the number of virtual tours completed during the 3-month period of intervention | 3 months |
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