Clinical trial NCT03679715: A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers
Official title: Effects of the Montreal Museum of Fine Arts Participatory Art-based Activity on Health of Older Community Dwellers: THE A-HEALTH RCT STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Interaction
Quality of Life
Health, Subjective
Keywords: Community-dwellers
older adults
museum
art
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 235
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief summary: The overall objective of the study is to examine the effects of the Montreal Museum of Fine Arts (MMFA) participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.

Aging is often associated with worsening health and withdrawal from social activities, both increasing the risk of a poor quality of life. It has been reported that the practice of art, especially participatory art-based activity enhances wellbeing, quality of life and health condition of patients and older adults. Since October 2015, the Montreal Museum of Fine Arts (MMFA; Quebec, Canada) has successfully initiated a participatory art-based activity known as "Les Beaux-Jeudis" for older community dwellers living in Montreal. Recently, the investigator demonstrated that the MMFA participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

Detailed description: Background. Recently, the investigator demonstrated that the Montreal Museum of Fine-Arts (MMFA) participatory art-based activity improved wellbeing, quality of life and health condition of Montreal older community dwellers using a pre-post single arm, prospective and longitudinal design. The main limitation of this pilot study was its design: it was not a randomized controlled trial (RCT) which is the gold standard to examine the effects of an intervention.

Objectives. The overall objective is to examine the effect of the MMFA participatory art-based activity on wellbeing, quality of life and health condition in older community dwellers.

The specific objectives are to compare the changes in 1) wellbeing, 2) quality of life and 3) health condition in older community dwellers participating in the museum participatory art-based activity (Intervention group) and in age and sex-matched older community dwellers who are not participants in the museum participatory art-based activity (Control group) during the same period of time. In addition, the compliance to museum participatory art-based activity in intervention will be examined. A second study, based on the same process, has been proceeded in Japan (Tokyo). With merging the 2 databases, we will study the impact of cultural specificities, comparing data collected in Montreal and data collected in Tokyo.

Methods. 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 of Intervention and Control groups) and analyzed with the intention-to-treat.

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

The follow-up period will be 3 months, which is the duration of a session of the museum participatory art-based activity. Assessment of wellbeing, quality of life and health condition will be performed at baseline, at the beginning of second and third months, and at the end of third month.

The same study has been developed and realized in Japan. Data collected in Canada will be merged with data collected in Japan and the analysis will be repeated for this international database.

Eligibility criteria: 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 or Japanese)
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 museums,
3. not speaking the language of the study.

Primary outcomes:
measure: Health condition assessed by self-administered questionnaire (SAQ)
timeFrame: 3 months
Secondary outcomes:
measure: Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire (CPQ)
timeFrame: 1 day
measure: Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire
timeFrame: 3 months
measure: Quality of life of participants assessed by EuroQol-5D self-questionnaire
timeFrame: 3 months
measure: Compliance assessed counting the number of workshops completed during the 3-month period of intervention.
timeFrame: 3 months
measure: Satisfaction concerning the project assessed by self-questionnaire
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Tokyo
country: Japan
facility: Arts Alive
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beauchet O, Cooper-Brown LA, Hayashi Y, Deveault M, Launay CP. Improving the mental and physical health of older community-dwellers with a museum participatory art-based activity: results of a multicentre randomized controlled trial. Aging Clin Exp Res. 2022 Jul;34(7):1645-1654. doi: 10.1007/s40520-022-02139-3. Epub 2022 May 17.
citation: Beauchet O, Cooper-Brown L, Hayashi Y, Galery K, Vilcocq C, Bastien T. Effects of "Thursdays at the Museum" at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol. Trials. 2020 Aug 12;21(1):709. doi: 10.1186/s13063-020-04625-3.