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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

Tracking Information
First Submitted Date  ICMJE September 18, 2018
First Posted Date  ICMJE September 20, 2018
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE January 5, 2019
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 20, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
Health condition assessed by self-administered questionnaire (SAQ) [ Time Frame: 3 months ]
self-administered questionnaire (SAQ)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2018)
  • 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
  • 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)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • Ability to use a computer assessed by Computer proficiency questionnaire self-questionnaire [ Time Frame: 1 day ]
    Computer proficiency questionnaire self-questionnaire
  • Well-being assessed by Warwick-Edinburgh Mental Well-being Scale self-questionnaire [ Time Frame: 3 months ]
    Warwick-Edinburgh Mental Well-being Scale self-questionnaire
  • Quality of life of participants assessed by EuroQol-5D self-questionnaire [ Time Frame: 3 months ]
    EuroQol-5D self-questionnaire
  • 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-month period of intervention.
  • Satisfaction concerning the project assessed by self-questionnaire [ Time Frame: 1 day ]
    self-questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A-Health RCT: Effects of Participatory Art-based Activity on Health of Older Community Dwellers
Official Title  ICMJE Effects of the Montreal Museum of Fine Arts Participatory Art-based Activity on Health of Older Community Dwellers: THE A-HEALTH RCT STUDY
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Social Interaction
  • Quality of Life
  • Health, Subjective
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: Intervention group
    The participants in the Intervention group will be participants of the museum participatory art-based activity.
    Intervention: Other: participatory art-based activity
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 2, 2020)
235
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2018)
150
Actual Study Completion Date  ICMJE December 1, 2020
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03679715
Other Study ID Numbers  ICMJE 2019-1493
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Olivier Beauchet, Jewish General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jewish General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivier Beauchet, MD Jewish General Hospital
PRS Account Jewish General Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP