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A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers (A-Health-RCT)

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: NCT03679715
Recruitment Status : Completed
First Posted : September 20, 2018
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Olivier Beauchet, Jewish General Hospital

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.


Condition or disease Intervention/treatment Phase
Social Interaction Quality of Life Health, Subjective Other: participatory art-based activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 5, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 1, 2020

Arm Intervention/treatment
Experimental: Intervention group
The participants in the Intervention group will be participants of the museum participatory art-based activity.
Other: participatory art-based activity

The intervention is a participatory art-based activity which consists in making art in group, involving the participants directly in the creative process, allowing them to become co-authors of the work.

In Montreal, Canada, participants will meet once per week for a 2h workshop from 2.00 PM to 4.00 PM at the MMFA in a dedicated room during a three month-period defining "a session". Two successive sessions will be setup; a winter and a spring sessions. Each session will be composed of 12 consecutive workshops.

In Tokyo, Japan, participants will meet once per week for a 2h workshop at the Tokyo Fuji Museum in a dedicated room during a three month-period defining "a session". The session will be composed of 12 consecutive workshops.


No Intervention: Control Group
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 museum participatory art-based activity.



Primary Outcome Measures :
  1. Health condition assessed by self-administered questionnaire (SAQ) [ Time Frame: 3 months ]
    self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty


Secondary Outcome Measures :
  1. Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire (CPQ) [ Time Frame: 1 day ]
    Computer proficiency questionnaire self-questionnaire, self-estimation of different tasks on informatics devices quoted from Never tried to Very easily (high score for proficiency in informatics). Score for each categories is calculated from the mean of the sub-questions scored from 0 to 4

  2. Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire [ Time Frame: 3 months ]
    Warwick-Edinburgh Mental Well-being Scale self-questionnaire, quoting statement of feelings and thought from None of the Time to All of the time, scoring from 14 to 70 (high score for a good well-being)

  3. Quality of life of participants assessed by EuroQol-5D self-questionnaire [ Time Frame: 3 months ]
    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

  4. Compliance assessed counting the number of workshops completed during the 3-month period of intervention. [ Time Frame: 3 months ]
    assessed counting the number of workshops completed during the 3-months period of intervention.

  5. Satisfaction concerning the project assessed by self-questionnaire [ Time Frame: 1 day ]
    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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679715


Locations
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Canada, Quebec
Jewish General Hospital
Montréal, Quebec, Canada, H3T 1E2
Japan
Arts Alive
Tokyo, Japan
Sponsors and Collaborators
Jewish General Hospital
Investigators
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Principal Investigator: Olivier Beauchet, MD Jewish General Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olivier Beauchet, Principal Investigator, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03679715    
Other Study ID Numbers: 2019-1493
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olivier Beauchet, Jewish General Hospital:
Community-dwellers
older adults
museum
art