Quality of Life Clinical Trial
Official title:
A 3-month Cycle of Weekly Montreal Museum of Fine Arts Tours to Promote Social Inclusion, Well-being, Quality of Life and Health in Older Community Members Experiencing Social Isolation
Verified date | February 2024 |
Source | Jewish General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Social isolation in older community-members living in urban areas and its possible reduction through a 3-month cycle of weekly museum tours.
Status | Active, not recruiting |
Enrollment | 128 |
Est. completion date | December 2025 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: 1. Being 65 years and over 2. 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 3. Understanding and writing the language of the recruitment centre (i.e., French or English) 4. Life expectancy estimated over 3 months as the duration of the follow-up is 3 months Exclusion Criteria: 1. Concomitant participation to another clinical trial, 2. Having participated to a participatory art-based activity of the MMFA, 3. Not speaking the language of the study. |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Jewish General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Frailty | The Centre of Excellence on longevity Self-AdMinistered questionnaire (CESAM). This questionnaire is composed of 20 items examining different domains including weight loss; polypharmacy; vision, hearing and memory issues; use of home support (i.e., family, friend and/or professional); the activity of daily living and the instrumental activity daily living scales; mood; practice of regular physical activity and history of falls in the past 12 months. | 3 months | |
Secondary | Well-being | Assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) questionnaire. The WEMWBS covers most aspects of positive mental health (positive thoughts and feelings). Its score ranges from 14 (i.e., none of the time) to 70 (i.e., all the time) | 3 months | |
Secondary | Quality of life using the EuroQol-5D (EQ-5D) | EuroQol-5D self-questionnaire, evaluating mobility, usual activities, self-care, pain, anxiety and mood, from No problem to Unable, scored from 5 to 25, High score meaning a bad quality of life. | 3 months | |
Secondary | Participants' socio-demographic characteristics | i.e., age, sex, marital status defined as married, living common-law, single, separated, divorced or widowed, place of living defined as home versus residence) and low household income using Canadian low-income cut-off | 3 months | |
Secondary | Interpersonal interactions | evaluation adapted from Observed Emotions Rating Scale (OERS). The OERS is about the completion of observations of 5 categories listed in order to give an overall look at the participants' interpersonal interactions based on expression of emotions. The 5 categories are; 1/ pleasure, 2/ anger, 3/ anxiety/fear, 4/ sadness, 5/ general alertness. | 3 months | |
Secondary | Compliance assessed counting the number of workshops completed during the 3-month period of intervention. | assessed counting the number of workshops completed during the 3-months period of intervention. | 3 month | |
Secondary | Satisfaction concerning the project assessed by self-questionnaire | self-questionnaire, qualitative (from 1 to 10: Dissatisfying to Satisfying), NO GLOBAL SCORE, each question is evaluated separately. A mean of all questions to have a global note (/10) will eventually be done for each participant. | 1 day |
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